- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425691
SPACE for Youth With Chronic Pain
Development of a Parent Training Intervention for Pediatric Patients With Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christina Murphy, PhD
- Phone Number: 215-590-6577
- Email: murphyc11@chop.edu
Study Contact Backup
- Name: Julia Ney, MA
- Phone Number: 215-590-6577
- Email: neyjs@chop.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94025
- Not yet recruiting
- Stanford Children's Health
-
Contact:
- Rashmi Bhandari, PhD
- Phone Number: 650-724-5333
- Email: rbhandar@stanford.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Christina Murphy, PhD
- Phone Number: 215-590-6577
- Email: murphyc11@chop.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Youth with chronic pain
Youth with chronic pain will complete questionnaires assessing secondary outcome measures prior to the start of the parent-only group intervention. The parent-only group intervention is 6 weekly, 90 minute sessions held over a secure virtual platform. Sessions will focus on orientation to the group, psychoeducation about pain neuroscience, and the role of parents in pain management, how parents can increase support for their child as well as decrease behaviors that may inadvertently maintain or reinforce pain and pain-related behaviors. Sessions will be recorded to ensure consistency in session content across groups. Homework will be assigned to parents after each session and will be reviewed the following week. Youth with chronic pain will then be asked to complete questionnaires at the end of the intervention, and at 1-month and 3-month follow up time points. Questionnaire completion is expected to take about 20 minutes at each time point. |
|
|
Parents of youth with chronic pain
Parents of youth with chronic pain will complete questionnaires assessing secondary outcome measures prior to the start of the parent-only group intervention. The parent-only group intervention is 6 weekly, 90 minute sessions held over a secure virtual platform. Sessions will focus on orientation to the group, psychoeducation about pain neuroscience, and the role of parents in pain management, how parents can increase support for their child as well as decrease behaviors that may inadvertently maintain or reinforce pain and pain-related behaviors. Sessions will be recorded to ensure consistency in session content across groups. Homework will be assigned to parents after each session and will be reviewed the following week. Parents of youth with chronic pain will be asked to complete questionnaires at the end of the intervention (45 minutes), and repeat some of the questionnaires at follow up time points (35-40 minutes). |
Originally developed for pediatric anxiety disorders, SPACE equips parents to reduce accommodation while maintaining a warm, empathic stance.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Acceptance
Time Frame: 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.
|
From enrollment through the end of the treatment (6-8 weeks)
|
|
Acceptability - Client Satisfaction
Time Frame: 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. |
Post-treatment (6-8 weeks)
|
|
Acceptability - Provider
Time Frame: 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. |
Post-treatment (6-8 weeks)
|
|
Provider Intervention Appropriateness
Time Frame: 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 |
Post-treatment (6-8 weeks)
|
|
Feasibility - Provider
Time Frame: 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 |
Post-treatment (6-8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety - Child
Time Frame: 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. |
Baseline
|
|
Anxiety - Child
Time Frame: Post-Treatment (6-8 weeks)
|
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. Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
Post-Treatment (6-8 weeks)
|
|
Anxiety - Child
Time Frame: 1 month Post-Treatment
|
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. Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
1 month Post-Treatment
|
|
Anxiety - Child
Time Frame: 3 months Post-Treatment
|
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. Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points. |
3 months Post-Treatment
|
|
Anxiety - Parent
Time Frame: 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. |
Baseline
|
|
Anxiety - Parent
Time Frame: Post-Treatment (6-8 weeks)
|
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. |
Post-Treatment (6-8 weeks)
|
|
Anxiety - Parent
Time Frame: 1 month Post-Treatment
|
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. |
1 month Post-Treatment
|
|
Anxiety - Parent
Time Frame: 3 months Post-Treatment
|
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. |
3 months Post-Treatment
|
|
Depression - Child
Time Frame: 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. |
Baseline
|
|
Depression - Child
Time Frame: Post-Treatment (6-8 weeks)
|
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. |
Post-Treatment (6-8 weeks)
|
|
Depression - Child
Time Frame: 1 month Post-Treatment
|
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. |
1 month Post-Treatment
|
|
Depression - Child
Time Frame: 3 months Post-Treatment
|
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. |
3 months Post-Treatment
|
|
Depression - Parent
Time Frame: 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. |
Baseline
|
|
Depression - Parent
Time Frame: Post-Treatment (6-8 weeks)
|
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. |
Post-Treatment (6-8 weeks)
|
|
Depression - Parent
Time Frame: 1 month Post-Treatment
|
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. |
1 month Post-Treatment
|
|
Depression - Parent
Time Frame: 3 months Post-Treatment
|
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. |
3 months Post-Treatment
|
|
Parent Stress
Time Frame: 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. |
Baseline
|
|
Parent Stress
Time Frame: Post-Treatment (6-8 weeks)
|
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). Overall possible scores on the scale range from 18 - 90. 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. |
Post-Treatment (6-8 weeks)
|
|
Parent Stress
Time Frame: 1 month Post-Treatment
|
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. |
1 month Post-Treatment
|
|
Parent Stress
Time Frame: 3 months Post-Treatment
|
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. |
3 months Post-Treatment
|
|
Parent Accommodation
Time Frame: 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. |
Baseline
|
|
Parent Accommodation
Time Frame: Post-Treatment (6-8 weeks)
|
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. |
Post-Treatment (6-8 weeks)
|
|
Parent Accommodation
Time Frame: 1 month Post-Treatment
|
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. |
1 month Post-Treatment
|
|
Parent Accommodation
Time Frame: 3 months Post-Treatment
|
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. |
3 months Post-Treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christina Murphy, PhD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-023906
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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