SPACE for Youth With Chronic Pain
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-17
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Children ages 10-17 years old with a chronic pain condition.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Supportive Parenting for Anxious Childhood Emotions - Pain
BehavioralOriginally developed for pediatric anxiety disorders, SPACE equips parents to reduce accommodation while maintaining a warm, empathic stance.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Youth with chronic pain0 interventions
Group B: Parents of youth with chronic pain1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Acceptance
Feasibility of intervention as measured by the mean of number of sessions attended. Local session documents will track each session.
Time frame
From enrollment through the end of the treatment (6-8 weeks)2
Acceptability - Client Satisfaction
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.
Time frame
Post-treatment (6-8 weeks)3
Acceptability - Provider
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.
Time frame
Post-treatment (6-8 weeks)4
Provider Intervention Appropriateness
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
Time frame
Post-treatment (6-8 weeks)Secondary outcomes
1
Anxiety - Child
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.
Time frame
Baseline2
Anxiety - Child
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.
Time frame
Post-Treatment (6-8 weeks)3
Anxiety - Child
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.
Time frame
1 month Post-Treatment4
Anxiety - Child
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.
Time frame
3 months Post-TreatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Stanford Children's Health
Collaborator
Source ClinicalTrials.gov