Abdominal Pain (AP), Chronic Pain, Complex Regional Pain Syndromes (CRPS), Fibromyalgia, Musculoskeletal Pain, Neuropathic Pain
Conditions
Brief summary
This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways. Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.
Detailed description
Background and Rationale: Chronic pain is common in youth and is associated with significant long-term physical and mental health consequences, yet it remains under-recognized and undertreated. Cognitive behavioral therapy (CBT) is an effective treatment, but access barriers limit its reach, leaving a gap for scalable, accessible interventions. Empowered Relief (ER) is a single-session, skills-based intervention that has produced outcomes comparable to multi-session CBT in adults; a youth adaptation (ER-Y) has shown strong feasibility, acceptability, and effectiveness. At the same time, caregiver distress, including anxiety and depressive symptoms, is associated with worse child pain outcomes, but few brief, accessible interventions exist to support caregivers themselves. To address this gap, the investigators co-designed Empowered Relief for Caregivers (ER-CY), a brief virtual intervention for caregivers of youth with chronic pain, and designed this study to evaluate its feasibility, acceptability, and preliminary effectiveness. Objectives: The study has two aims. Aim 1 is to assess the feasibility and acceptability of ER-CY, indexed by participant attendance and ratings of credibility and satisfaction. Aim 2 is to evaluate preliminary effectiveness, indexed by caregiver distress, caregiver behavior in response to their child's pain, and parent-reported youth pain interference. The investigators hypothesize that ER-CY will demonstrate strong feasibility and acceptability and that caregivers will show reduced distress and reduced unhelpful responses to pain, along with improvements in youth pain-related functioning over time. Design and Procedures: This is a single-group study enrolling up to 80 caregivers of youth with chronic pain, conducted at the Pediatric Pain Management Clinic at Stanford Medicine Children's Health. Caregivers identified through the clinic complete an eligibility questionnaire, a screening call, and informed consent, and then complete baseline surveys via REDCap. Participants attend one approximately two-hour ER-CY class delivered virtually via Zoom and complete post-class surveys immediately afterward. Within one to two weeks, participants complete a semi-structured qualitative interview, which is audio- and video-recorded for analysis. Outcome and monitoring assessments are repeated at 1, 2, and 3 months following the intervention. Changes over time will be examined using mixed-effects models, and no interim analysis is planned.
Interventions
BEHAVIORALEmpowered Relief for Caregivers (ER-CY)
Empowered Relief for Caregivers is a single-session, skills-based behavioral intervention delivered virtually via Zoom in one session of approximately two hours. Co-designed with caregivers, it adapts the Empowered Relief approach for caregivers of youth with chronic pain, teaching strategies to reduce caregiver distress and to respond more adaptively to a child's pain. All participants receive the same single class; there are no additional sessions or booster components.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Caregiver of a youth with a chronic pain diagnosis (\>3 months in duration) * English speaking
Exclusion criteria
* Significant psychosocial complexity based on clinical team assessment (e.g., severe depression/anxiety, unable to tolerate a group setting)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Expectancy and Credibility: Caregiver Version | Immediately post class | The Treatment Expectancy and Credibility: Caregiver Version assesses treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations. |
| Program Feedback Scale | Immediately post class | The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = "really disagree" to 4 = "really agree") with a higher score indicating positive feedback and two open ended questions. |
| Exit Interview | 1-2 weeks post class | Semi-structured qualitative interview conducted with caregivers following the ER-CY class to assess intervention acceptability and gather feedback on their experience. Interviews are audio/video recorded, transcribed, and analyzed thematically to characterize caregivers' perspectives on program content, delivery, perceived helpfulness, and suggestions for refinement. |
Secondary
| Measure | Time frame |
|---|---|
| Adult Responses to Children's Symptoms (ARCS) - Protect Subscale | Pre-class, 1 month, 2 months, and 3 months post class |
| Bath Adolescent Pain Parental Impact Questionnaire | Pre-class, 1 month, 2 months, and 3 months post class |
| Child Activity Limitations Interview-9 | Pre-class, 1 month, 2 months, and 3 months post class |
| Generalized Anxiety Disorder-2 | Pre-class, 1 month, 2 months, and 3 months post class |
| Pain Catastrophizing Scale - Parent | Pre-class, 1 month, 2 months, and 3 months post class |
| Pain Catastrophizing Scale | Pre-class, 1 month, 2 months, and 3 months post class |
| Patient Health Questionnaire-2 | Pre-class, 1 month, 2 months, and 3 months post class |
| Parent Psychological Flexibility Questionnaire - 10 | Pre-class, 1 month, 2 months, and 3 months post class |
| Parent Risk and Impact Screening Measure - 12 | Pre-class, 1 month, 2 months, and 3 months post class |
Countries
United States
Contacts
CONTACTJeremy Giberson
CONTACTSahrish Masood
PRINCIPAL_INVESTIGATORLaura Simons, PhD
Stanford University
Outcome results
None listed