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Empowered Relief for Caregivers (ER-CY)

3. juni 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • California
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford University
        • Ledende efterforsker:
          • Laura Simons, PhD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Program Feedback-skala
Tidsramme: Umiddelbart efter undervisningen
Program Feedback-skalaen vurderer deltagernes accept af syv udsagn, der angiver deres opfattede acceptabilitet og gennemførlighed baseret på en skala (score 0 = "virkelig uenig" til 4 = "virkelig enig") med en højere score, der indikerer positiv feedback og to åbne spørgsmål.
Umiddelbart efter undervisningen
Treatment Expectancy and Credibility: Caregiver Version
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Adult Responses to Children's Symptoms (ARCS) - Protect Subscale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Pre-class, 1 month, 2 months, and 3 months post class
Pre-class, 1 month, 2 months, and 3 months post class

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Laura Simons, PhD, Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

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