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Empowered Relief for Caregivers (ER-CY)

2026년 8월 17일 업데이트: Laura E Simons, Stanford University

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

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

행동: Empowered Relief for Caregivers (ER-CY)

상세 설명

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.

연구 유형

중재적

등록 (추정된)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Jeremy Giberson
전화번호: 650-723-5814
이메일: jgiberso@stanford.edu

연구 연락처 백업

이름: Sahrish Masood
이메일: sahrishm@stanford.edu

연구 장소

미국
- California
  - Palo Alto, California, 미국, 94304
    - Stanford University
    - 수석 연구원:
      
      Laura Simons, PhD
    - 연락하다:
      
      Jeremy Giberson
      
      전화번호: 650-723-5814
      
      이메일: jgiberso@stanford.edu
    - 연락하다:
      
      Sahrish Masood
      
      이메일: sahrishm@stanford.edu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 해당 없음
중재 모델: 단일 그룹 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Empowered Relief for Caregivers (ER-CY) Participants in this single-group study attend one approximately two-hour Empowered Relief for Caregivers class, a co-designed, skills-based intervention delivered virtually via Zoom. The class teaches caregivers of youth with chronic pain strategies to manage their own distress and to respond adaptively to their child's pain. All enrolled participants receive the ER-CY intervention; there is no comparison arm.	행동: 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.

참가자 그룹 / 팔

개입 / 치료

실험적: Empowered Relief for Caregivers (ER-CY)

Participants in this single-group study attend one approximately two-hour Empowered Relief for Caregivers class, a co-designed, skills-based intervention delivered virtually via Zoom. The class teaches caregivers of youth with chronic pain strategies to manage their own distress and to respond adaptively to their child's pain. All enrolled participants receive the ER-CY intervention; there is no comparison arm.

행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
프로그램 피드백 척도 기간: 수업 직후	프로그램 피드백 척도는 척도(점수 0 = "정말 동의하지 않음" ~ 4 = "정말 동의함")를 기반으로 인지된 수용 가능성 및 실행 가능성을 나타내는 7개의 진술에 대한 참가자의 동의를 평가하며, 점수가 높을수록 긍정적인 피드백과 두 개의 개방형 질문을 나타냅니다.	수업 직후
Treatment Expectancy and Credibility: Caregiver Version 기간: 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.	Immediately post class
Exit Interview 기간: 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.	1-2 weeks post class

2차 결과 측정

결과 측정	기간
Adult Responses to Children's Symptoms (ARCS) - Protect Subscale 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Bath Adolescent Pain Parental Impact Questionnaire 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Child Activity Limitations Interview-9 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Generalized Anxiety Disorder-2 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Pain Catastrophizing Scale - Parent 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Pain Catastrophizing Scale 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Patient Health Questionnaire-2 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Parent Psychological Flexibility Questionnaire - 10 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class
Parent Risk and Impact Screening Measure - 12 기간: Pre-class, 1 month, 2 months, and 3 months post class	Pre-class, 1 month, 2 months, and 3 months post class

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Stanford University

수사관

수석 연구원: Laura Simons, PhD, Stanford University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2028년 9월 1일

연구 등록 날짜

최초 제출

2026년 6월 3일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 17일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

86875

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Empowered Relief for Caregivers (ER-CY)