Chronic Pain
Conditions
Brief summary
The primary objective is to assess the feasibility and acceptability of a group-based parent training intervention for parents of youth with chronic pain. Secondary objectives include evaluating changes in child functional impairment, pain intensity, and parent accommodation.
Interventions
BEHAVIORALSupportive Parenting for Anxious Childhood Emotions - Pain
Originally developed for pediatric anxiety disorders, SPACE equips parents to reduce accommodation while maintaining a warm, empathic stance.
Sponsors
Children's Hospital of Philadelphia
Stanford Children's Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Inclusion criteria
* Children aged 10-17 with chronic pain (≥3 months) and associated functional impairment * Parent/guardian living with the child ≥50% of the time * Parent and child are fluent in English
Exclusion criteria
* Pain better explained by another medical condition * History of psychosis, bipolar disorder, autism spectrum disorder, or intellectual disability (child) * Current emotional, cognitive, or physical barrier to participation for caregiver, as determined by clinical judgment of study personnel * Severe psychiatric symptoms requiring immediate intervention * Ongoing individual Cognitive Behavioral Therapy (CBT) for pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Acceptance | From enrollment through the end of the treatment (6-8 weeks) | Feasibility of intervention as measured by the mean of number of sessions attended. Local session documents will track each session. |
| Acceptability - Client Satisfaction | Post-treatment (6-8 weeks) | Client satisfaction with the intervention will be measured by the patient-reported Client Satisfaction Questionnaire. The Client Satisfaction Questionnaire is an 8-item, widely used, self-report measure for assessing general client satisfaction with mental health services. It uses a 4-point Likert scale for each question. This will be administered to parents, who received the intervention. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. Parents of youth with chronic pain will be asked to complete this measure at the end of the intervention. |
| Acceptability - Provider | Post-treatment (6-8 weeks) | Provider will assess the acceptability of the measure by the Acceptability of Intervention Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher acceptability. Providers will be asked to complete this measure at the end of the intervention. |
| Provider Intervention Appropriateness | Post-treatment (6-8 weeks) | Provider will assess the appropriateness of the measure by the Intervention Appropriateness Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher degree of appropriateness. Providers will be asked to complete this measure at the end of the intervention |
| Feasibility - Provider | Post-treatment (6-8 weeks) | Provider will assess the feasibility of the measure by the Feasibility of Intervention Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher degree of feasibility. Providers will be asked to complete this measure at the end of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety - Child | Baseline | This 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
| Anxiety - Parent | Baseline | This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
| Depression - Child | Baseline | The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Child report form is 8 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
| Depression - Parent | Baseline | The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Parent report form is 6 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
| Parent Stress | Baseline | The Parent Stress Scale is an 18-item self-report scale. Items represent positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, restrictions) themes of parenthood. Respondents agree or disagree in terms of their typical relationship with their child. Responses are measured on a 5-point likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated by summing each item score. Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of Parental stress. Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
| Parent Accommodation | Baseline | The Inventory of Parent Accommodations to Children's Symptoms (IPACS) is an 11-item parent report form that assesses the degree to which parents accommodate their child's pain. Responses are captured on a 5-point likert scale (0, "never" to 4, "always"). A total score is calculated by summing each item score. Overall possible scores range from 0 to 44 with higher scores suggesting greater parental accommodation. Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Murphy, PhD
Children's Hospital of Philadelphia
Outcome results
None listed