Asthma
Conditions
Keywords
psychosocial stress
Brief summary
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children. A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes. Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
Detailed description
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children. A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes. Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support. We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.
Interventions
BEHAVIORALParental stress management
The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches.
OTHERUsual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Sponsors
Patient-Centered Outcomes Research Institute
Stephen J. Teach, MD, MPH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
We plan to enroll parent-child dyads that meet the following criteria: Inclusion criteria (Parent): * self-identify as African-American * both the legal guardian and primary asthma caregiver of an eligible child.
Exclusion criteria
(Parent): * unable or unwilling to sign informed consent document * exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment * enrolled in another asthma research study. Inclusion criteria (Child): * parent-identified as African-American * age 4-12 years inclusive at recruitment * physician diagnosis of persistent asthma * publicly financed insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom-free Days in the Last 14 Days | Repeated Measures at 6 months (3 month data collected to allow for repeated measures) | Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Depression | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms. |
| Economic Outcomes | 12m follow-up period | Analysis of costs of care in both groups |
| Caregiver Smoking Behavior | Repeated Measures at 6 and 12 months | parent report of cigarettes smoked per day |
| Coping Strategies | Repeated measures at 12m FU (6m data used for repeated measures) | Brief COPE |
| Mindfulness | Repeated Measures at 6 and 12 months | Interpersonal Mindfulness in Parenting |
| Parental Resilience | Repeated Measures at 6 and 12 months | Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism. |
| Exacerbations - Hospital Admissions | Assessed at 6m and 12m after enrollment | Number of participants with hospital admissions due to exacerbations |
| Symptom-free Days in the Last 14 Days | Repeated Measures at 12 months (with data also assessed at 3m and 6m) | Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications |
| Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Repeated measures at 6 and 12 months (3m data collected for repeated measures) | Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d |
| Asthma Morbidity - Nighttime Asthma Symptoms | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | Nights of asthma symptoms in prior 14d |
| Asthma Severity and Control | Repeated Measures at 3, 6, and 12 months | — |
| Asthma Medication Adherence | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | Reported use of inhaled corticosteroids and LTRA in past two days |
| Health Care Utilization - Emergency Department Visits for Asthma | 12 months after enrollment | Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere |
| Asthma Exacerbations - Courses of Systemic Steroids | Assessed at 6m and 12m following enrollment | Courses of systemic steroids over 12m follow up period |
| Parental Stress | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress. |
| Child Anxiety | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression. |
| Child Depression | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression. |
| Caregiver Quality of Life | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed. |
| Number of Participants With AEs and SAEs | 12m follow up period | Safety data: Number of Participants with AEs and SAEs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parental Health Literacy | Baseline | Single Item Literacy Screener (SILS) |
| Use of Existing Ancillary Services | Assessed at 6m and 12m following enrollment | — |
| Parental Resilience | Baseline | Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism. |
| Intervention Component Uptake | 6 month intervention period | Completion of intervention sessions |
| Intervention Satisfaction | 6 month intervention period | Brief survey of satisfaction with intervention components. |
| Intervention Fidelity | 6 month intervention period | Checklist of staff's fidelity to individual components of intervention protocol |
| Sociodemographics | Baseline | Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history |
| Number of Participants With Positive Smoke Exposure | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) | Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: How often did anyone smoke inside the home where child usually lives? or How often did anyone smoke in the room where child usually sleeps? A positive response on either or both questions was considered positive exposure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination | 110 |
| Intervention Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches. | 107 |
| Total | 217 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Categorical Child Participants <=18 years | 110 Participants | 217 Participants | 107 Participants |
| Age, Categorical Child Participants >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Child Participants Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Parent Participants <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Parent Participants >=65 years | 2 Participants | 5 Participants | 3 Participants |
| Age, Categorical Parent Participants Between 18 and 65 years | 108 Participants | 212 Participants | 104 Participants |
| Age, Continuous Child Participants | 6.4 years STANDARD_DEVIATION 2.3 | 6.6 years STANDARD_DEVIATION 2.3 | 6.8 years STANDARD_DEVIATION 2.3 |
| Age, Continuous Parent Participants | 33.2 years STANDARD_DEVIATION 8.9 | 33.8 years STANDARD_DEVIATION 9.5 | 34.3 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 110 participants | 217 participants | 107 participants |
| Sex: Female, Male Child Participants Female | 42 Participants | 85 Participants | 43 Participants |
| Sex: Female, Male Child Participants Male | 68 Participants | 132 Participants | 64 Participants |
| Sex: Female, Male Parent Participants Female | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male Parent Participants Male | 10 Participants | 17 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 107 |
| other Total, other adverse events | 0 / 110 | 0 / 107 |
| serious Total, serious adverse events | 0 / 110 | 0 / 107 |
Outcome results
Primary
Symptom-free Days in the Last 14 Days
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Time frame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Population: Randomized participants with follow up available at each time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Symptom-free Days in the Last 14 Days | 11.4 days in prior 14d | Standard Deviation 3.3 |
| Intervention | Symptom-free Days in the Last 14 Days | 11.6 days in prior 14d | Standard Deviation 3 |
Comparison: At 6 Monthsp-value: 0.93Generalized Linear Model Analysis
Secondary
Asthma Exacerbations - Courses of Systemic Steroids
Courses of systemic steroids over 12m follow up period
Time frame: Assessed at 6m and 12m following enrollment
Population: Participants with data available at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids over 6 Months | 0.30 Courses of systemic steroids | Standard Error 0.63 |
| Usual Care | Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids btwn 6m and 12m FU | 0.26 Courses of systemic steroids | Standard Error 0.61 |
| Intervention | Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids over 6 Months | 0.29 Courses of systemic steroids | Standard Error 0.68 |
| Intervention | Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids btwn 6m and 12m FU | 0.30 Courses of systemic steroids | Standard Error 0.67 |
Comparison: Courses of systemic steroids over 6 monthsp-value: 0.98Generalized Linear Model Analysis
Comparison: Courses of systemic steroids between 6m and 12m FUp-value: 0.48Generalized Linear Model Analysis
Secondary
Asthma Medication Adherence
Reported use of inhaled corticosteroids and LTRA in past two days
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants with Follow Up Data Available at Each Time Point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Asthma Medication Adherence | ICS use at 6 Month Follow Up | 68 Participants |
| Usual Care | Asthma Medication Adherence | ICS use at 12 Month Follow up | 55 Participants |
| Usual Care | Asthma Medication Adherence | LTRA use at 6 Month Follow Up | 14 Participants |
| Usual Care | Asthma Medication Adherence | LTRA use at 12 Month Follow Up | 20 Participants |
| Intervention | Asthma Medication Adherence | LTRA use at 12 Month Follow Up | 18 Participants |
| Intervention | Asthma Medication Adherence | ICS use at 6 Month Follow Up | 68 Participants |
| Intervention | Asthma Medication Adherence | LTRA use at 6 Month Follow Up | 16 Participants |
| Intervention | Asthma Medication Adherence | ICS use at 12 Month Follow up | 61 Participants |
Comparison: ICS Use at 6 Month Follow Upp-value: 0.35Generalized Linear Model Analysis
Comparison: ICS Use at 12 Month Follow Upp-value: 0.34Generalized Linear Model Analysis
Comparison: LTRA Use at 6 Monthsp-value: 0.35Generalized Linear Model Analysis
Comparison: LTRA use at 12 Month Follow Upp-value: 0.62Generalized Linear Model Analysis
Secondary
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Time frame: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants with data available at each follow up time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Daytime asthma symptoms at 12m FU | 2.31 days in prior 14d | Standard Deviation 3.24 |
| Usual Care | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of activity limitation at 12m | 1.66 days in prior 14d | Standard Deviation 2.99 |
| Usual Care | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Daytime asthma symptoms at 6m FU | 1.64 days in prior 14d | Standard Deviation 2.48 |
| Usual Care | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of activity limitation at 6m | 1.42 days in prior 14d | Standard Deviation 2.53 |
| Usual Care | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of quick relief medicine use at 12m | 3.40 days in prior 14d | Standard Deviation 4.16 |
| Usual Care | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of quick relief medicine use at 6m | 2.75 days in prior 14d | Standard Deviation 3.59 |
| Intervention | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of quick relief medicine use at 12m | 2.85 days in prior 14d | Standard Deviation 3.99 |
| Intervention | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Daytime asthma symptoms at 6m FU | 1.83 days in prior 14d | Standard Deviation 2.66 |
| Intervention | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Daytime asthma symptoms at 12m FU | 1.57 days in prior 14d | Standard Deviation 2.39 |
| Intervention | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of activity limitation at 6m | 1.04 days in prior 14d | Standard Deviation 1.74 |
| Intervention | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of activity limitation at 12m | 1.12 days in prior 14d | Standard Deviation 2.31 |
| Intervention | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of quick relief medicine use at 6m | 2.96 days in prior 14d | Standard Deviation 4.26 |
p-value: 0.54Generalized Linear Model Analysis
p-value: 0.11Generalized Linear Model Analysis
p-value: 0.82Generalized Linear Model Analysis
p-value: 0.84Generalized Linear Model Analysis
p-value: 0.7Generalized Linear Model Analysis
p-value: 0.58Generalized Linear Model Analysis
Secondary
Asthma Morbidity - Nighttime Asthma Symptoms
Nights of asthma symptoms in prior 14d
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants with data available at each follow up time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Asthma Morbidity - Nighttime Asthma Symptoms | Nighttime asthma symptoms at 6 Month FU | 1.7 days in prior 14d | Standard Deviation 2.9 |
| Usual Care | Asthma Morbidity - Nighttime Asthma Symptoms | Nighttime asthma symptoms at 12 Month FU | 2.1 days in prior 14d | Standard Deviation 3.2 |
| Intervention | Asthma Morbidity - Nighttime Asthma Symptoms | Nighttime asthma symptoms at 6 Month FU | 1.9 days in prior 14d | Standard Deviation 3.2 |
| Intervention | Asthma Morbidity - Nighttime Asthma Symptoms | Nighttime asthma symptoms at 12 Month FU | 1.5 days in prior 14d | Standard Deviation 2.3 |
Comparison: At 6 month follow upp-value: 0.87Generalized Linear Model Analysis
Comparison: At 12 month follow upp-value: 0.25Generalized Linear Model Analysis
Secondary
Asthma Severity and Control
Time frame: Repeated Measures at 3, 6, and 12 months
Population: Data not collected
Secondary
Caregiver Quality of Life
Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants with follow up available at each time point. Note use of modified scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Caregiver Quality of Life | Score at 12 Month Follow Up | 58.1 units on a scale | Standard Deviation 8.4 |
| Usual Care | Caregiver Quality of Life | Score at 6 month Follow Up | 57.6 units on a scale | Standard Deviation 8.8 |
| Intervention | Caregiver Quality of Life | Score at 6 month Follow Up | 58.9 units on a scale | Standard Deviation 8.1 |
| Intervention | Caregiver Quality of Life | Score at 12 Month Follow Up | 57.8 units on a scale | Standard Deviation 8.4 |
Comparison: Quality of Life at 6 Month Follow upp-value: 0.53Generalized Linear Model Analysis
Comparison: Quality of Life at 12 Month Follow upp-value: 0.57Generalized Linear Model Analysis
Secondary
Caregiver Smoking Behavior
parent report of cigarettes smoked per day
Time frame: Repeated Measures at 6 and 12 months
Population: We are unable to analyze or report the data because it was not systematically collected.
Secondary
Child Anxiety
PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants available at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Child Anxiety | Score at 6 Month Follow up | 42.5 units on a scale | Standard Deviation 9.6 |
| Usual Care | Child Anxiety | Score at 12 Month Follow Up | 43.1 units on a scale | Standard Deviation 10.2 |
| Intervention | Child Anxiety | Score at 6 Month Follow up | 40.4 units on a scale | Standard Deviation 7.8 |
| Intervention | Child Anxiety | Score at 12 Month Follow Up | 41.5 units on a scale | Standard Deviation 8.4 |
Comparison: At 6 Month Follow Upp-value: 0.7Generalized Linear Model Analysis
Comparison: At 12 Month Follow Upp-value: 0.8Generalized Linear Model Analysis
Secondary
Child Depression
PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants available at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Child Depression | Score at 6 Month Follow Up | 41.1 units on a scale | Standard Deviation 7.7 |
| Usual Care | Child Depression | Score at 12 Month Follow Up | 42.3 units on a scale | Standard Deviation 9.1 |
| Intervention | Child Depression | Score at 6 Month Follow Up | 40.6 units on a scale | Standard Deviation 7 |
| Intervention | Child Depression | Score at 12 Month Follow Up | 41.2 units on a scale | Standard Deviation 7.6 |
Comparison: 6 Month Follow Upp-value: 0.53Generalized Linear Model Analysis
Comparison: 12 Month Follow upp-value: 0.77Generalized Linear Model Analysis
Secondary
Coping Strategies
Brief COPE
Time frame: Repeated measures at 12m FU (6m data used for repeated measures)
Population: While we have collected this data, its analysis will be complex and require significant resources. We lack those resources at this time. We may at some point in the future return to this analysis.
Comparison: Score on Brief COPE at 12 Monthsp-value: 0.58Generalized Linear Model Analysis
Secondary
Economic Outcomes
Analysis of costs of care in both groups
Time frame: 12m follow-up period
Population: Data were not collected
Secondary
Exacerbations - Hospital Admissions
Number of participants with hospital admissions due to exacerbations
Time frame: Assessed at 6m and 12m after enrollment
Population: Participants with data available at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Exacerbations - Hospital Admissions | Pts hospitalized btwn enrollment and 6m FU | 5 Participants |
| Usual Care | Exacerbations - Hospital Admissions | Pts hospitalized btwn 6m and 12m FU | 7 Participants |
| Intervention | Exacerbations - Hospital Admissions | Pts hospitalized btwn enrollment and 6m FU | 4 Participants |
| Intervention | Exacerbations - Hospital Admissions | Pts hospitalized btwn 6m and 12m FU | 9 Participants |
Secondary
Health Care Utilization - Emergency Department Visits for Asthma
Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere
Time frame: 12 months after enrollment
Population: Participants with follow up available at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Health Care Utilization - Emergency Department Visits for Asthma | ED Visits between enrollment and 6m Follow Up | 0.32 Visits | Standard Error 0.68 |
| Usual Care | Health Care Utilization - Emergency Department Visits for Asthma | ED Visits between 6m and 12m Follow up | 0.33 Visits | Standard Error 0.65 |
| Intervention | Health Care Utilization - Emergency Department Visits for Asthma | ED Visits between enrollment and 6m Follow Up | 0.32 Visits | Standard Error 0.77 |
| Intervention | Health Care Utilization - Emergency Department Visits for Asthma | ED Visits between 6m and 12m Follow up | 0.42 Visits | Standard Error 0.75 |
Comparison: ED visits over 6 monthsp-value: 0.63Generalized Linear Model Analysis
Comparison: ED Visits between 6 and 12 Month follow upp-value: 0.44Generalized Linear Model Analysis
Secondary
Mindfulness
Interpersonal Mindfulness in Parenting
Time frame: Repeated Measures at 6 and 12 months
Population: We are unable to analyze or report the data because it was not systematically collected.
Secondary
Number of Participants With AEs and SAEs
Safety data: Number of Participants with AEs and SAEs
Time frame: 12m follow up period
Population: Participants available at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With AEs and SAEs | 6 Month Follow Up | 0 Participants |
| Usual Care | Number of Participants With AEs and SAEs | 12 Month Follow up | 0 Participants |
| Intervention | Number of Participants With AEs and SAEs | 6 Month Follow Up | 0 Participants |
| Intervention | Number of Participants With AEs and SAEs | 12 Month Follow up | 0 Participants |
p-value: 1Fisher Exact
Secondary
Parental Depression
Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Participants available at each follow up time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Parental Depression | CES-D 10 score at 12 Month Follow up | 7.6 units on a scale | Standard Deviation 5.7 |
| Usual Care | Parental Depression | CES-D 10 score at 6 Month Follow up | 6.8 units on a scale | Standard Deviation 4.8 |
| Intervention | Parental Depression | CES-D 10 score at 12 Month Follow up | 8.0 units on a scale | Standard Deviation 5.8 |
| Intervention | Parental Depression | CES-D 10 score at 6 Month Follow up | 7.4 units on a scale | Standard Deviation 5.2 |
Comparison: At 6 Month follow upp-value: 0.32Generalized Linear Model Analysis
Comparison: At 12 month follow upp-value: 0.44Generalized Linear Model Analysis
Secondary
Parental Resilience
Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Time frame: Repeated Measures at 6 and 12 months
Population: Participants with follow up available at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Parental Resilience | Score on LOT-R at 6 Month Follow Up | 16.1 units on a scale | Standard Deviation 3.3 |
| Usual Care | Parental Resilience | Score on LOT-R at 12 month Follow Up | 16.7 units on a scale | Standard Deviation 3.3 |
| Intervention | Parental Resilience | Score on LOT-R at 6 Month Follow Up | 16.5 units on a scale | Standard Deviation 4.5 |
| Intervention | Parental Resilience | Score on LOT-R at 12 month Follow Up | 16.9 units on a scale | Standard Deviation 4.1 |
Comparison: Score on LOT-R at 6 Month Follow Upp-value: 0.46Generalized Linear Model Analysis
Comparison: Score on LOT-R at 12 Month Follow Upp-value: 0.62Generalized Linear Model Analysis
Secondary
Parental Stress
Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Number of participants with follow up available at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Parental Stress | PSS Score at 6 Month Follow Up | 10.4 units on a scale | Standard Deviation 7.3 |
| Usual Care | Parental Stress | PSS Score at 12 Month Follow up | 10.3 units on a scale | Standard Deviation 7.2 |
| Intervention | Parental Stress | PSS Score at 6 Month Follow Up | 11.4 units on a scale | Standard Deviation 7.1 |
| Intervention | Parental Stress | PSS Score at 12 Month Follow up | 12.6 units on a scale | Standard Deviation 7.8 |
Comparison: At 6 Month Follow Upp-value: 0.32Generalized Linear Model Analysis
Comparison: At 12 Month Follow Upp-value: 0.06Generalized Linear Model Analysis
Secondary
Symptom-free Days in the Last 14 Days
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Time frame: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Population: Participants with data available at 12m follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Symptom-free Days in the Last 14 Days | 10.9 days | Standard Deviation 3.7 |
| Intervention | Symptom-free Days in the Last 14 Days | 11.8 days | Standard Deviation 2.9 |
p-value: 0.35Generalized Linear Model Analysis
Other Pre-specified
Intervention Component Uptake
Completion of intervention sessions
Time frame: 6 month intervention period
Population: Intervention group only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Intervention Component Uptake | Completed 0 Intervention Sessions | 8 Participants |
| Usual Care | Intervention Component Uptake | Completed 1 Intervention Session | 15 Participants |
| Usual Care | Intervention Component Uptake | Completed 2 Intervention Sessions | 4 Participants |
| Usual Care | Intervention Component Uptake | Completed 3 Intervention Sessions | 5 Participants |
| Usual Care | Intervention Component Uptake | Completed 4 Intervention Sessions | 75 Participants |
Other Pre-specified
Intervention Fidelity
Checklist of staff's fidelity to individual components of intervention protocol
Time frame: 6 month intervention period
Other Pre-specified
Intervention Satisfaction
Brief survey of satisfaction with intervention components.
Time frame: 6 month intervention period
Population: Participants with data available at 6 month follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Intervention Satisfaction | Very Much satisfied with individual sessions | 82 Participants |
| Usual Care | Intervention Satisfaction | Very Much satisfied with delivery of sessions | 86 Participants |
Other Pre-specified
Number of Participants With Positive Smoke Exposure
Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: How often did anyone smoke inside the home where child usually lives? or How often did anyone smoke in the room where child usually sleeps? A positive response on either or both questions was considered positive exposure.
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Population: Number of participants with follow up data available at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Positive Smoke Exposure | 6 Month Follow Up | 13 Participants |
| Usual Care | Number of Participants With Positive Smoke Exposure | 12 Month Follow up | 13 Participants |
| Intervention | Number of Participants With Positive Smoke Exposure | 6 Month Follow Up | 10 Participants |
| Intervention | Number of Participants With Positive Smoke Exposure | 12 Month Follow up | 9 Participants |
Comparison: ETS exposure at 6 Month Follow Upp-value: 0.91Generalized Linear Model Analysis
Comparison: ETS Exposure at 12 Month Follow upp-value: 0.98Generalized Linear Model Analysis
Other Pre-specified
Parental Health Literacy
Single Item Literacy Screener (SILS)
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Parental Health Literacy | Never needs assistance | 98 Participants |
| Usual Care | Parental Health Literacy | Needs any assistance | 12 Participants |
| Intervention | Parental Health Literacy | Never needs assistance | 95 Participants |
| Intervention | Parental Health Literacy | Needs any assistance | 12 Participants |
p-value: 0.94Chi-squared
Other Pre-specified
Parental Resilience
Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Parental Resilience | 16.1 units on a scale | Standard Deviation 3.3 |
| Intervention | Parental Resilience | 16.2 units on a scale | Standard Deviation 3.5 |
p-value: 0.9Wilcoxon (Mann-Whitney)
Other Pre-specified
Sociodemographics
Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Sociodemographics | Child Race : African American | 110 Participants |
| Usual Care | Sociodemographics | Parent Education: Grade 1-11 | 9 Participants |
| Usual Care | Sociodemographics | Child Ethnicity: Non-Hispanic | 110 Participants |
| Usual Care | Sociodemographics | Parent Education: GED or 12th grade | 44 Participants |
| Usual Care | Sociodemographics | Parent Ethnicity: Non-Hispanic | 110 Participants |
| Usual Care | Sociodemographics | Parent Education: Some college/associates degree | 39 Participants |
| Usual Care | Sociodemographics | Public Insurance | 110 Participants |
| Usual Care | Sociodemographics | Parent Education: College Graduate | 18 Participants |
| Usual Care | Sociodemographics | Parent Race : African American | 110 Participants |
| Intervention | Sociodemographics | Parent Education: College Graduate | 14 Participants |
| Intervention | Sociodemographics | Parent Race : African American | 107 Participants |
| Intervention | Sociodemographics | Child Race : African American | 107 Participants |
| Intervention | Sociodemographics | Parent Ethnicity: Non-Hispanic | 106 Participants |
| Intervention | Sociodemographics | Child Ethnicity: Non-Hispanic | 106 Participants |
| Intervention | Sociodemographics | Public Insurance | 107 Participants |
| Intervention | Sociodemographics | Parent Education: Grade 1-11 | 19 Participants |
| Intervention | Sociodemographics | Parent Education: GED or 12th grade | 41 Participants |
| Intervention | Sociodemographics | Parent Education: Some college/associates degree | 33 Participants |
Comparison: Parent educationp-value: 0.2Chi-squared
Other Pre-specified
Use of Existing Ancillary Services
Time frame: Assessed at 6m and 12m following enrollment
Population: Participants with data available at each follow up point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Use of Existing Ancillary Services | Parent use of mental health resources at 6 Months | 19 Participants |
| Usual Care | Use of Existing Ancillary Services | Parent use of mental health resources at 12 Months | 28 Participants |
| Intervention | Use of Existing Ancillary Services | Parent use of mental health resources at 6 Months | 30 Participants |
| Intervention | Use of Existing Ancillary Services | Parent use of mental health resources at 12 Months | 28 Participants |
Comparison: Parent use of mental health resources at 6 Monthsp-value: 0.02Generalized Linear Model Analysis
Comparison: Parent use of mental health resources at 12 Monthsp-value: 0.85Generalized Linear Model Analysis