Inflammatory Bowel Disease
Conditions
Keywords
Psychosocial Stress and Adjustment, Pediatric Chronic Illness, Decision-support tool, Integrated Health Care, Case Complexity
Brief summary
The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate identification of areas of high need and risk for each patient. The focus of the present study is to examine the characteristics and usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents will participate in a semi-structured structured interview with a clinical nurse who will then rate the 34-PIM items. To examine the construct validity of each of the Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care system) participants will complete questionnaires assessing social and psychological functioning, parent and family stress, quality of life and adaptive functioning. Information about disease status, and health care utilization will be obtained from medical chart review. It is hypothesized that greater case complexity will be predictive of more complex disease course/treatment, poorer quality of life, and increased health care utilization.
Detailed description
Inflammatory Bowel Disease (Crohn's disease/ulcerative colitis) manifests itself in children and adolescents in up to 1/3 of those that will eventually develop these conditions. It is fast becoming an increasing problem with a 50% increase in Crohn's disease diagnosed in young children in the last decade. The patient's chronic symptoms can be both due to and result in increased child and family psychosocial stress. Similarly, treatments may add to psychosocial stress. Failure to address these psychosocial issues can lead to greater risk for poor treatment adherence, higher utilization of health care, and increased psychiatric co-morbidity. As such, improvement in health care providers' capacity to identify factors contributing to case complexity offers significant potential for improving outcomes. Assessment of biological, psychological, social and health delivery of children's chronic illness has not been consistently integrated into the health care system. Physical and mental health services are often disconnected. Identifying those who would benefit from a mental health referral typically rests on the primary care physician or specialist and is often triggered by crises. There is also variability in physician education and comfort level in assessing psychosocial issues and especially in children with chronic illnesses in which symptoms of physical disease and mental health can overlap. Oftentimes this leaves the most responsible physician wanting for a simple assessment tool to try and determine who might be at risk and benefit from mental health intervention. The adult INTERMED is a clinical decision-support tool that provides indicators of biological, psychological, social, heath care needs, as well as an overall index of case complexity. The tool is efficient to administer and has been successfully used by varied health care professionals in diverse medical settings to detect psychosocial needs, facilitate referral to effective services and improve health practices and outcomes. However, there is no comparable validated tool for use with children/youth. The investigators have recently developed a pediatric adaptation of the adult INTERMED to address the unique developmental and social contexts of children and youth. A Delphi group of international experts in the field of pediatric chronic illness has reviewed the instrument to ensure clinical relevance, utility and communication clarity. Initial pilot data has demonstrated the Pediatric INTERMED has very good item inter-rater reliability. The focus of the current study is to examine the usefulness of this tool to identify biopsychosocial needs in IBD children/youth. Canada has a very high IBD incidence and prevalence. Given the facts that children with IBD face an unpredictable disease course, complex symptoms and difficult management regimens that can significantly impact their lives, it is not surprising that patients with this chronic incurable condition are highly vulnerable to mental health comorbidities. The development of this new tool will have significant importance if it proves to be useful in this population. The current study will examine a sizeable cohort of patients with regards to the relations between Pediatric INTERMED domains and other measures of children's disease, mood, behaviour, quality of life, family stress and strengths, and health services utilization. Both ulcerative colitis and Crohn's disease in children and youth lend themselves very well to this study because of the validated measures of disease severity that have been developed already. Implementation of the novel Pediatric INTERMED n clinical practice will provide a new way to assist IBD Teams in screening their patients to be proactive in referral to mental health resources, and facilitate case management which targets patient needs. Clearly, clinicians are well aware that compliance, anxiety and depression will affect disease outcomes and too often these are only dealt with at times of crisis that has led to disease flare or reports that medicines are no longer effective. Use of this structured assessment tool begins to realize the potential of developing a truly integrated biopsychosocial approach to this chronic disease. The ease of use and objective nature of the tool will enhance communication among primary and tertiary providers and contribute to best practice approaches in the provision of integrated physical and mental health care. It will also assist in monitoring the impact of childhood chronic illness, identify factors linked to optimal health outcomes and inform program planning and resource allocations. Study Design Children/youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of Eastern Ontario (CHEO) with confirmed diagnoses of IBD (Crohn's disease or ulcerative colitis) are eligible for the study. A clinical nurse will complete the Pediatric INTERMED for all study participants: based on information obtained from a review of the patients' hospital chart and a semi-structured interview conducted with the child/youth and primary caregivers), Following the Pediatric INTERMED interview, children/youth and parents participating in the project will complete a battery of self-report instruments to provide assessments of patients' social and psychological functioning, parent/family stresses, adjustment and resources. In addition, information will be obtained from the patients' charts about aspects of their diagnoses, treatment regimens, disease activity and complications, and health care utilization in the 3 months prior to their participation in the study. Primary Hypotheses/Objectives and Statistical Rationale 1. Demonstrate that the Pediatric INTERMED is a reliable tool for use in IBD children (good inter-rater reliability and internal consistency). 40 interviews with the clinical research nurse will be videotaped so that a second health care professional trained in the use of the PIM, can also complete the PIM tool, in order to examine inter-rater reliability. Agreement between raters will be measured by means of intraclass correlations. Items within each domain will be examined to confirm that they meet internal consistency criteria (Cronbach's Alpha of .80). 2. Demonstrate that the Pediatric INTERMED domains successfully identify patient needs. Concurrent validity of the Pediatric INTERMED will be examined by looking at the Spearman rank, Pearson correlations, as appropriate, between each domain score and the measures hypothesized to be conceptually linked to the domain. To assess aspects of the Psychological Domain, the patients will complete the Children's Depression Inventory, the Multidimensional Anxiety Scale for Children and parents will complete the Child Behaviour Checklist (CBCL). Measures linked to the Social Domain of the PIM, include The Functional Disability Inventory, which taps the child's involvement in daily activities, and CBCL Competence Scores (Social, School, Activities), and the IMPACT-III, an IBD specific quality of life measure. To examine constructs linked to the Caregiver/Family Domain parents will complete the Pediatric Inventory for Parents, an index of childhood illness-related parenting stress, the Family Inventory of Life Events and Changes and the Family Inventory of Resources for Management. Disease/treatment and health care data gathered will be used to validate the Biological and Health System Domains. 3. Demonstrate that Pediatric INTERMED Complexity score is predictive of increased health care utilization. A general linear approach will be used to study the relation of the Pediatric INTERMED to health service utilization. Multivariate models will also be tested including potential covariates such as disease severity, time since diagnosis. Statistical Power Calculations The CHEO GI clinic sees 40 to 60 new patients diagnosed with IBD per year. In 2007 the clinic actively followed 265 children with IBD. Once diagnosed children are followed on an ongoing basis. The frequency of follow-up appointments varies depending on the nature and course of a child's disease, but the children/youth are seen at minimum three times each year. In general, participation rates in studies of children/youth with chronic illness are typically in the vicinity of 80-90% or better and this figure is consistent with the experience of the CHEO IBD clinic in the recruitment of patients into various knowledge generation studies. The PIM involves 5 domains of information inclusive of various components. To achieve significance with the various domains the investigators estimated that a total of 140-150 children will need to be enrolled. This sample size is sufficient to ensure that there are a sufficient number of observations per variable to conduct multivariate analyses. Tabachnick and Fidell (2007) and others indicated that 4 is the absolute minimum number of observations per variable to conduct multivariate analyses. A subject size of 140-150 would be sufficient to provide 4 observations per variable. Further, the anticipated sample size is sufficient to conduct all proposed analyses. Further corrections for multiple testing will be applied on a per-analysis basis.
Interventions
None listed
Sponsors
Janssen Inc.
Children's Hospital of Eastern Ontario
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of IBD (Crohn's or Ulcerative Colitis) * fluency in English or French * between the ages of 8 and 17 * residing in the CHEO catchment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric INTERMED- Complexity Index | Time of Study Participation (Completion of Pediatric INTERMED tool) | 34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action). Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains: Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity). Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity). Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity). Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity). Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity). |
| Correlations Between Pediatric INTERMED Domain Scores | Pediatric INTERMED scores at time of study participation | Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores. |
| Pediatric INTERMED Items | Day 1 (At time of Pediatric Intermed Interview) | Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. |
| IBD Disease Severity | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe. |
| Time Since IBD Diagnosis | Data collected through chart review at time of Pediatric INTERMED interview. | Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in months since date of diagnosis, with a range from 1 - 131 months. |
| Disease Course and Treatment | Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview) | Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record). |
| IBD Treatment With Immunomodulators or Anti-TNFa Medications | Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview). | Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as yes (Score of 1) or no (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as yes (Score of 1) or no (Score of 2). |
| Functional Disability Inventory | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) no trouble to (4) impossible. The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p\<.001) between the FDI and an objective index of disability (Walker & Greene, 1991). |
| Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. | Day 1 (At time of Pediatric Intermed Interview) | 35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008). |
| Child Behaviour Checklist | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores. |
| Children's Depression Inventory | Administered at study entry | 27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences. |
| Multidimensional Anxiety Scale for Children | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) never true about me to (3) often true about me. Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences. |
| Pediatric Inventory for Parents- Difficulty Score | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater perceived difficulty. |
| Family Inventory of Life Events and Changes | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress. |
| Family Inventory of Resources for Management | Day 1 (Date of patient's participation in the Pediatric Intermed interview). | Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources. |
| Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis | Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire. |
| Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Day 1 (Time of Study Participation) | Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9). |
| Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. | Day 1 (At time of Pediatric Intermed Interview) | This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range. |
| Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. | Day 1 (At time of Pediatric Intermed Interview) | This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range. |
| Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. | Day 1 (At time of Pediatric Intermed Interview) | This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range. |
| Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. | Day 1 (At time of Pediatric Intermed Interview) | This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range. |
| Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis | Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management. |
| Total Number of Hospital Services Involved in Child's Care. | Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) | Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview. |
| Number of Calls to IBD Nurse | Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) | Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview |
| Number of Extra Appointments With the IBD Team | Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) | Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview. |
| Number of Visits to the Hospital Emergency Department | Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) | Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview. |
| Number of Inpatient Hospital Admissions | Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) | Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children and Youth With IBD Children/youth (ages 8-17) with confirmed diagnoses of IBD. | 148 |
| Total | 148 |
Baseline characteristics
| Characteristic | Children and Youth With IBD |
|---|---|
| Age, Continuous | 14.00 years |
| Region of Enrollment Canada | 148 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 148 |
| serious Total, serious adverse events | 0 / 148 |
Outcome results
Primary
Child Behaviour Checklist
Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Population: The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Children and Youth With IBD | Child Behaviour Checklist | CBCL Internalizing | 54 Units on a Scale - T Scores |
| Children and Youth With IBD | Child Behaviour Checklist | CBCL Externalizing | 46 Units on a Scale - T Scores |
| Children and Youth With IBD | Child Behaviour Checklist | CBCL Social Competence | 45 Units on a Scale - T Scores |
| Children and Youth With IBD | Child Behaviour Checklist | CBCL Activities Competence | 48 Units on a Scale - T Scores |
| Children and Youth With IBD | Child Behaviour Checklist | CBCL Academic Competence | 50 Units on a Scale - T Scores |
Primary
Children's Depression Inventory
27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.
Time frame: Administered at study entry
Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Children's Depression Inventory | 42 Units on a Scale - T Scores |
Primary
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators
Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.
Time frame: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Services involved in Child's Care | .26 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Hospitalizations since Diagnosis | .34 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Numbers of Surgeries since Hospitalization | .22 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | FIRM: Financial Well Being Scale | -.32 Correlation Coefficients |
| Psychological | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Numbers of Surgeries since Hospitalization | .25 Correlation Coefficients |
| Psychological | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Hospitalizations since Diagnosis | .36 Correlation Coefficients |
| Psychological | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Services involved in Child's Care | .08 Correlation Coefficients |
| Psychological | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | FIRM: Financial Well Being Scale | -.34 Correlation Coefficients |
| Social | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | FIRM: Financial Well Being Scale | -.13 Correlation Coefficients |
| Social | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Numbers of Surgeries since Hospitalization | .10 Correlation Coefficients |
| Social | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Hospitalizations since Diagnosis | .14 Correlation Coefficients |
| Social | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Services involved in Child's Care | .25 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Services involved in Child's Care | .37 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | FIRM: Financial Well Being Scale | -.03 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Hospitalizations since Diagnosis | .11 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Numbers of Surgeries since Hospitalization | .08 Correlation Coefficients |
| Health Service | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Numbers of Surgeries since Hospitalization | .13 Correlation Coefficients |
| Health Service | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | FIRM: Financial Well Being Scale | -.15 Correlation Coefficients |
| Health Service | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Hospitalizations since Diagnosis | .09 Correlation Coefficients |
| Health Service | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Services involved in Child's Care | .20 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Hospitalizations since Diagnosis | .23 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Numbers of Surgeries since Hospitalization | .11 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | FIRM: Financial Well Being Scale | -.36 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators | Number of Services involved in Child's Care | .15 Correlation Coefficients |
Comparison: Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Beingp-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being.p-value: <0.01Spearman Correlation Coefficient
Primary
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning
Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.
Time frame: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | .00 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | -.45 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .50 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | -.09 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | -.11 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | -.06 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | .10 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | .36 Correlation Coefficients |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | .52 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | .08 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | .06 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | .01 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .16 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | -.05 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | .10 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | -.18 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | .13 Correlation Coefficients |
| Psychological | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | .27 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | .06 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | .15 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | -.08 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | -.12 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | -.04 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | -.10 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | -.11 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | .03 Correlation Coefficients |
| Social | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .00 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | .53 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | .51 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | -.65 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | .02 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | -.01 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | .16 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | .09 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | -.09 Correlation Coefficients |
| Family/Caregiver | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .56 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | .14 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | .07 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | .20 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | -.24 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .20 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | -.10 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | .09 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | .12 Correlation Coefficients |
| Health Service | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | -.15 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | -.14 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | .04 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | .18 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | .09 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | -.32 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .03 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | -.42 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | -.01 Correlation Coefficients |
| Current Biological Item: Therapeutic Complexity | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | .17 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Study Enrolment | .18 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Disease Severity at Diagnosis | -.02 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index- Child Rating | .23 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Biological Immunodulators Since Diagnosis | -.06 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Impact III: General Well-Being Scale | -.17 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Surgeries since Diagnosis | .13 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Functional Disability Index - Parent Rating | .27 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Use of Chemical Immunomodulators since Diagnosis | -.20 Correlation Coefficients |
| Vulnerability Biological Item: Complications and Life Threat | Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning | Number of Courses of Prednisone since Diagnosis | -.07 Correlation Coefficients |
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosisp-value: >0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.p-value: >0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.p-value: >0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)p-value: <0.05Spearman Correlation Coefficent
Comparison: Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation.p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating).p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scalep-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeriesp-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation.p-value: <0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)p-value: <0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating).p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scalep-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. .p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medicationsp-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating).p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Beingp-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis.p-value: <0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate).p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab).p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation.p-value: <0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating).p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating).p-value: <0.01Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale.p-value: <0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone.p-value: >0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate).p-value: <0.05Spearman Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications.p-value: >0.05Spearman Correlation Coefficient
Primary
Correlations Between Pediatric INTERMED Domain Scores
Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.
Time frame: Pediatric INTERMED scores at time of study participation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Domain Scores | Biological | 1 Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Domain Scores | Caregiver/Family | .32 Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Domain Scores | Psychological | .29 Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Domain Scores | Social | .34 Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric INTERMED Domain Scores | Health Service | .19 Correlation Coefficient |
| Psychological | Correlations Between Pediatric INTERMED Domain Scores | Social | .65 Correlation Coefficient |
| Psychological | Correlations Between Pediatric INTERMED Domain Scores | Biological | .29 Correlation Coefficient |
| Psychological | Correlations Between Pediatric INTERMED Domain Scores | Caregiver/Family | .64 Correlation Coefficient |
| Psychological | Correlations Between Pediatric INTERMED Domain Scores | Psychological | 1 Correlation Coefficient |
| Psychological | Correlations Between Pediatric INTERMED Domain Scores | Health Service | .42 Correlation Coefficient |
| Social | Correlations Between Pediatric INTERMED Domain Scores | Psychological | .65 Correlation Coefficient |
| Social | Correlations Between Pediatric INTERMED Domain Scores | Social | 1 Correlation Coefficient |
| Social | Correlations Between Pediatric INTERMED Domain Scores | Caregiver/Family | .63 Correlation Coefficient |
| Social | Correlations Between Pediatric INTERMED Domain Scores | Biological | .34 Correlation Coefficient |
| Social | Correlations Between Pediatric INTERMED Domain Scores | Health Service | .41 Correlation Coefficient |
| Family/Caregiver | Correlations Between Pediatric INTERMED Domain Scores | Social | .63 Correlation Coefficient |
| Family/Caregiver | Correlations Between Pediatric INTERMED Domain Scores | Caregiver/Family | 1 Correlation Coefficient |
| Family/Caregiver | Correlations Between Pediatric INTERMED Domain Scores | Psychological | .64 Correlation Coefficient |
| Family/Caregiver | Correlations Between Pediatric INTERMED Domain Scores | Health Service | .53 Correlation Coefficient |
| Family/Caregiver | Correlations Between Pediatric INTERMED Domain Scores | Biological | .32 Correlation Coefficient |
| Health Service | Correlations Between Pediatric INTERMED Domain Scores | Health Service | 1 Correlation Coefficient |
| Health Service | Correlations Between Pediatric INTERMED Domain Scores | Caregiver/Family | .53 Correlation Coefficient |
| Health Service | Correlations Between Pediatric INTERMED Domain Scores | Social | .41 Correlation Coefficient |
| Health Service | Correlations Between Pediatric INTERMED Domain Scores | Biological | .19 Correlation Coefficient |
| Health Service | Correlations Between Pediatric INTERMED Domain Scores | Psychological | .42 Correlation Coefficient |
p-value: <0.05Pearson Correlation Coefficients
Comparison: Correlation between the Biological and Social domain scores on the Pediatric INTERMED.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Biological and Health Service Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Psychology and Social Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Social and Health Service Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.p-value: <0.01Pearson Correlation Coefficient
Primary
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.
Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).
Time frame: Day 1 (Time of Study Participation)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Family Inventory of Life Events | .31 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Internalizing Score | .56 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Externalizing Score | .52 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Social Competence | -.32 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Children's Depression Inventory | .41 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Family Inventory of Resources for Management | -.26 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Multidimensional Anxiety Scale for Children | .24 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Activities Competence | -.18 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Academic Competence | -.50 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Impact III: Social Interactions | .40 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Impact III: Emotional Functioning | -.35 Pearson Correlation Coefficient |
| Children and Youth With IBD | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | PIP Difficulty Score | .22 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Children's Depression Inventory | .46 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | PIP Difficulty Score | .41 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Internalizing Score | .46 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Impact III: Emotional Functioning | -.30 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Activities Competence | -.23 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Multidimensional Anxiety Scale for Children | .19 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Impact III: Social Interactions | -.38 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Family Inventory of Life Events | .36 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Social Competence | -.38 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Academic Competence | -.59 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Family Inventory of Resources for Management | -.28 Pearson Correlation Coefficient |
| Psychological | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Externalizing Score | .42 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Family Inventory of Resources for Management | -.46 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Externalizing Score | .38 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Children's Depression Inventory | .38 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Multidimensional Anxiety Scale for Children | .14 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Impact III: Emotional Functioning | -.33 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Social Competence | -.29 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Activities Competence | -.27 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Academic Competence | -.35 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Impact III: Social Interactions | -.37 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | CBCL Internalizing Score | .46 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | PIP Difficulty Score | .39 Pearson Correlation Coefficient |
| Social | Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. | Family Inventory of Life Events | .41 Pearson Correlation Coefficient |
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Scorep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.p-value: <0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scalep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).p-value: 0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).p-value: <0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scalep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).p-value: <0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Scorep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.p-value: <0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scalep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scalep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Scorep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.p-value: >0.05Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scalep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scalep-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).p-value: <0.01Pearson Correlation Coefficient
Comparison: Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).p-value: <0.01Pearson Correlation Coefficient
Primary
Disease Course and Treatment
Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).
Time frame: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Children and Youth With IBD | Disease Course and Treatment | Number of Hospitalizations since Diagnosis | 1 number of times it occurred |
| Children and Youth With IBD | Disease Course and Treatment | Number of Surgeries Since Diagnosis | 0 number of times it occurred |
| Children and Youth With IBD | Disease Course and Treatment | Number of Courses of Prednisone | 1 number of times it occurred |
Primary
Family Inventory of Life Events and Changes
Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Family Inventory of Life Events and Changes | 7 units on a scale |
Primary
Family Inventory of Resources for Management
Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Children and Youth With IBD | Family Inventory of Resources for Management | Firm: Total Score | 127 units on a scale |
| Children and Youth With IBD | Family Inventory of Resources for Management | FIRM: Financial Well-being Scale | 36 units on a scale |
Primary
Functional Disability Inventory
Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) no trouble to (4) impossible. The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p\<.001) between the FDI and an objective index of disability (Walker & Greene, 1991).
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Children and Youth With IBD | Functional Disability Inventory | FDI - Child Report | 4 units on a scale |
| Children and Youth With IBD | Functional Disability Inventory | FDI- Parent Report | 2 units on a scale |
Primary
IBD Disease Severity
IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | IBD Disease Severity | Disease Severity at Pediatric INTERMED Interview | 62.8 percentage of participants |
| Children and Youth With IBD | IBD Disease Severity | Disease Severity at Diagnosis | 4.3 percentage of participants |
| Psychological | IBD Disease Severity | Disease Severity at Diagnosis | 25.7 percentage of participants |
| Psychological | IBD Disease Severity | Disease Severity at Pediatric INTERMED Interview | 25.7 percentage of participants |
| Social | IBD Disease Severity | Disease Severity at Pediatric INTERMED Interview | 8.1 percentage of participants |
| Social | IBD Disease Severity | Disease Severity at Diagnosis | 32.1 percentage of participants |
| Family/Caregiver | IBD Disease Severity | Disease Severity at Pediatric INTERMED Interview | 3.4 percentage of participants |
| Family/Caregiver | IBD Disease Severity | Disease Severity at Diagnosis | 37.9 percentage of participants |
Primary
IBD Treatment With Immunomodulators or Anti-TNFa Medications
Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as yes (Score of 1) or no (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as yes (Score of 1) or no (Score of 2).
Time frame: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | IBD Treatment With Immunomodulators or Anti-TNFa Medications | Use of Immunomodulators | 55.4 Percentage of participants treated |
| Children and Youth With IBD | IBD Treatment With Immunomodulators or Anti-TNFa Medications | Use of anti-TNFa Medications | 42.6 Percentage of participants treated |
Primary
Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.
35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).
Time frame: Day 1 (At time of Pediatric Intermed Interview)
Population: The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Children and Youth With IBD | Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. | Impact III: Social Interactions | 22 units on a scale |
| Children and Youth With IBD | Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. | Impact III: General Well-Being | 57 units on a scale |
| Children and Youth With IBD | Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. | Impact III: Emotional Functioning | 45 units on a scale |
Primary
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
Population: The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 5 participants |
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 3 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 8 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 119 participants |
95% CI: [5, 122.84]
Primary
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
Population: The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 8 participants |
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 22 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 5 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 100 participants |
95% CI: [2.17, 24.36]
Primary
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
Population: The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 3 participants |
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 4 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 11 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 125 participants |
95% CI: [1.7, 43.02]
Primary
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
Population: The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 4 participants |
| Children and Youth With IBD | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 6 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. | No Mental Health/Cognitive Vulnerability | 125 participants |
| Psychological | Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. | Mental Health/Cognitive Vulnerability Need | 10 participants |
95% CI: [2.02, 34.47]
Primary
Multidimensional Anxiety Scale for Children
Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) never true about me to (3) often true about me. Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Multidimensional Anxiety Scale for Children | 50.00 units on a scale- T scores |
Primary
Number of Calls to IBD Nurse
Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Number of Calls to IBD Nurse | 0 Number of calls |
Comparison: A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.p-value: <0.01Regression, Linear
Primary
Number of Extra Appointments With the IBD Team
Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Number of Extra Appointments With the IBD Team | 0 Number of appointments |
Comparison: A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).p-value: <0.01Regression, Linear
Primary
Number of Inpatient Hospital Admissions
Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Number of Inpatient Hospital Admissions | 0 Number of hospital admissions |
Comparison: A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.p-value: <0.01Regression, Linear
Primary
Number of Visits to the Hospital Emergency Department
Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Number of Visits to the Hospital Emergency Department | 0 Emergency Department Visits |
Comparison: A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.p-value: <0.05Regression, Linear
Primary
Pediatric INTERMED- Complexity Index
34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action). Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains: Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity). Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity). Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity). Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity). Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).
Time frame: Time of Study Participation (Completion of Pediatric INTERMED tool)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Children and Youth With IBD | Pediatric INTERMED- Complexity Index | Total Complexity Index | 24 scores on a scale |
| Children and Youth With IBD | Pediatric INTERMED- Complexity Index | Pediatric INTERMED Biological Domain Score | 9.0 scores on a scale |
| Children and Youth With IBD | Pediatric INTERMED- Complexity Index | Pediatric INTERMED Psychological Domain Score | 4.0 scores on a scale |
| Children and Youth With IBD | Pediatric INTERMED- Complexity Index | Pediatric INTERMED Social Domain Score | 4.0 scores on a scale |
| Children and Youth With IBD | Pediatric INTERMED- Complexity Index | Pediatric INTERMED Caregiver/Family Domain Score | 4.0 scores on a scale |
| Children and Youth With IBD | Pediatric INTERMED- Complexity Index | Pediatric INTERMED Health Service Domain Score | 3.0 scores on a scale |
Primary
Pediatric INTERMED Items
Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Adverse Developmental Events | 84.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family: Caregiver Health/Function | 45.3 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family: Residential Stability | 60.1 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Resistance to Treatment | 49.3 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family: Caregiver/Family Support | 61.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family: Family Stress | 14.9 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Biological: Diagnostic Challenge | 60.8 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family: Parental Skills | 62.8 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Mental Health Symptoms | 36.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family/Caregiver System Vulnerability | 39.2 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Health System: Access to Health Care | 57.4 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Barriers to Coping | 37.8 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Health System: Treatment Experience | 51.4 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Cogntive/Functinonal Impairment | 96.6 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Health System: Organization of Care | 2 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Health System: Coordination of Care | 70.9 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Health System Impediments | 34.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Biological: Chronicity | .7 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Mental Health/Cognitive Threat | 31.8 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Family: Family Relationships | 58.8 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Biological: Therapeutic Complexity | 2.7 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Biological: Diagnostic Dilemma | .7 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Resiliency | 43.9 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Biological: Symptom Severity | 26.4 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social: School Functionning | 36.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Mental Health History | 51.4 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social: Social Functioning | 63.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social: Child/Youth Supports | 77.7 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social: School Attendance | 55.4 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Psychological: Cogntive/Intellectual Development | 79.7 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social: Educational NEeds | 54.1 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social: Community Participation | 61.5 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Biological: Complications and Life Threat | 2.7 Percentage of participants |
| Children and Youth With IBD | Pediatric INTERMED Items | Social System Vulnerability | 37.8 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Mental Health History | 30.4 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Mental Health/Cognitive Threat | 58.1 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family: Caregiver Health/Function | 43.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Biological: Complications and Life Threat | 73.6 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Cogntive/Intellectual Development | 17.6 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family: Residential Stability | 33.8 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family: Family Relationships | 33.1 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Biological: Chronicity | 1.4 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family: Caregiver/Family Support | 25.7 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Resistance to Treatment | 41.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social: Child/Youth Supports | 21.6 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family: Family Stress | 66.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Biological: Diagnostic Challenge | 20.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Biological: Diagnostic Dilemma | 20.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family: Parental Skills | 34.5 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Adverse Developmental Events | 12.8 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social: School Attendance | 25 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Family/Caregiver System Vulnerability | 55.4 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Mental Health Symptoms | 53.4 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Biological: Symptom Severity | 46.6 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Health System: Access to Health Care | 38.5 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Resiliency | 43.2 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Biological: Therapeutic Complexity | 6.1 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Health System: Treatment Experience | 43.2 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social: Community Participation | 28.4 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social: School Functionning | 43.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Health System: Organization of Care | 81.1 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Cogntive/Functinonal Impairment | 2.7 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social System Vulnerability | 52 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Health System: Coordination of Care | 25 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Psychological: Barriers to Coping | 45.9 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social: Educational NEeds | 27.7 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Health System Impediments | 61.5 Percentage of participants |
| Psychological | Pediatric INTERMED Items | Social: Social Functioning | 24.3 Percentage of participants |
| Social | Pediatric INTERMED Items | Health System Impediments | 4.1 Percentage of participants |
| Social | Pediatric INTERMED Items | Biological: Diagnostic Challenge | 18.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Biological: Therapeutic Complexity | 91.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Biological: Complications and Life Threat | 23.7 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Barriers to Coping | 16.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Resiliency | 12.8 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Mental Health History | 18.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Cogntive/Intellectual Development | 2.7 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Adverse Developmental Events | 2.7 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Resistance to Treatment | 8.8 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Mental Health Symptoms | 10.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Cogntive/Functinonal Impairment | .7 Percentage of participants |
| Social | Pediatric INTERMED Items | Biological: Chronicity | 98 Percentage of participants |
| Social | Pediatric INTERMED Items | Biological: Diagnostic Dilemma | 78.4 Percentage of participants |
| Social | Pediatric INTERMED Items | Biological: Symptom Severity | 27 Percentage of participants |
| Social | Pediatric INTERMED Items | Psychological: Mental Health/Cognitive Threat | 10.1 Percentage of participants |
| Social | Pediatric INTERMED Items | Social: School Functionning | 19.6 Percentage of participants |
| Social | Pediatric INTERMED Items | Social: Social Functioning | 12.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Social: Child/Youth Supports | .7 Percentage of participants |
| Social | Pediatric INTERMED Items | Social: School Attendance | 19.6 Percentage of participants |
| Social | Pediatric INTERMED Items | Social: Educational NEeds | 18.3 Percentage of participants |
| Social | Pediatric INTERMED Items | Social: Community Participation | 10.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Social System Vulnerability | 10.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Family: Family Relationships | 8.1 Percentage of participants |
| Social | Pediatric INTERMED Items | Family: Caregiver Health/Function | 10.8 Percentage of participants |
| Social | Pediatric INTERMED Items | Family: Residential Stability | 6.1 Percentage of participants |
| Social | Pediatric INTERMED Items | Family: Caregiver/Family Support | 12.8 Percentage of participants |
| Social | Pediatric INTERMED Items | Family: Family Stress | 18.2 Percentage of participants |
| Social | Pediatric INTERMED Items | Family: Parental Skills | 2.7 Percentage of participants |
| Social | Pediatric INTERMED Items | Family/Caregiver System Vulnerability | 5.4 Percentage of participants |
| Social | Pediatric INTERMED Items | Health System: Access to Health Care | 4.1 Percentage of participants |
| Social | Pediatric INTERMED Items | Health System: Treatment Experience | 5.4 Percentage of participants |
| Social | Pediatric INTERMED Items | Health System: Organization of Care | 16.9 Percentage of participants |
| Social | Pediatric INTERMED Items | Health System: Coordination of Care | 4.1 Percentage of participants |
Primary
Pediatric Inventory for Parents- Difficulty Score
Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater perceived difficulty.
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Population: The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Pediatric Inventory for Parents- Difficulty Score | 82 units on a scale |
Primary
Time Since IBD Diagnosis
Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in months since date of diagnosis, with a range from 1 - 131 months.
Time frame: Data collected through chart review at time of Pediatric INTERMED interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children and Youth With IBD | Time Since IBD Diagnosis | 15.5 Percentage of Participants |
| Psychological | Time Since IBD Diagnosis | 34.5 Percentage of Participants |
| Social | Time Since IBD Diagnosis | 32.4 Percentage of Participants |
| Family/Caregiver | Time Since IBD Diagnosis | 17.6 Percentage of Participants |
Primary
Total Number of Hospital Services Involved in Child's Care.
Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children and Youth With IBD | Total Number of Hospital Services Involved in Child's Care. | 2.00 R Square change statistic |
Comparison: A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.p-value: <0.01Regression, Linear