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Not yet recruiting NCT07636980

Empowered Relief for Caregivers

No phase Interventional Chronic Pain Musculoskeletal Pain Fibromyalgia Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empowered Relief for Caregivers (ER-CY).
Who it may be relevant to
Registry conditions: Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuropathic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Empowered Relief for Caregivers (ER-CY): A Co-Designed Brief Intervention to Support Families of Youth With Chronic Pain

Overview

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

  • Behavioral Empowered 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.

Primary outcome measures

  • Treatment Expectancy and Credibility: Caregiver Version [Time frame: Immediately post class]
  • Program Feedback Scale [Time frame: Immediately post class]
  • Exit Interview [Time frame: 1-2 weeks post class]
Secondary outcome measures (9)
  • Adult Responses to Children's Symptoms (ARCS) - Protect Subscale [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Bath Adolescent Pain Parental Impact Questionnaire [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Child Activity Limitations Interview-9 [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Generalized Anxiety Disorder-2 [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Pain Catastrophizing Scale - Parent [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Pain Catastrophizing Scale [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Patient Health Questionnaire-2 [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Parent Psychological Flexibility Questionnaire - 10 [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]
  • Parent Risk and Impact Screening Measure - 12 [Time frame: Pre-class, 1 month, 2 months, and 3 months post class]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Palo Alto

Identifiers

NCT: NCT07636980 · 86875

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗