- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07636980
Empowered Relief for Caregivers (ER-CY)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jeremy Giberson
- Numero di telefono: 650-723-5814
- Email: jgiberso@stanford.edu
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94304
- Stanford University
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Investigatore principale:
- Laura Simons, PhD
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Contatto:
- Jeremy Giberson
- Numero di telefono: 650-723-5814
- Email: jgiberso@stanford.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Scala di feedback del programma
Lasso di tempo: Subito dopo la lezione
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La scala di feedback del programma valuta l'accordo dei partecipanti su sette affermazioni che indicano la loro accettabilità e fattibilità percepite sulla base di una scala (punteggio da 0 = "veramente in disaccordo" a 4 = "veramente d'accordo") con un punteggio più alto che indica un feedback positivo e due domande aperte.
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Subito dopo la lezione
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Treatment Expectancy and Credibility: Caregiver Version
Lasso di tempo: Immediately post class
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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.
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Immediately post class
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Exit Interview
Lasso di tempo: 1-2 weeks post class
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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.
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1-2 weeks post class
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Adult Responses to Children's Symptoms (ARCS) - Protect Subscale
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Bath Adolescent Pain Parental Impact Questionnaire
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Child Activity Limitations Interview-9
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Generalized Anxiety Disorder-2
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Pain Catastrophizing Scale - Parent
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Pain Catastrophizing Scale
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Patient Health Questionnaire-2
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Parent Psychological Flexibility Questionnaire - 10
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Parent Risk and Impact Screening Measure - 12
Lasso di tempo: Pre-class, 1 month, 2 months, and 3 months post class
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Pre-class, 1 month, 2 months, and 3 months post class
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Laura Simons, PhD, Stanford University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie del sistema nervoso
- Malattie muscolari
- Malattie neuromuscolari
- Malattie reumatiche
- Segni e sintomi, Digestivo
- Malattie del sistema nervoso periferico
- Malattie del sistema nervoso autonomo
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore addominale
- Dolore muscoloscheletrico
- Fibromialgia
- Dolore cronico
- Nevralgia
- Sindromi Dolorose Regionali Complesse
- Force di lavoro e servizi per le strutture sanitarie
- Personale sanitario
- Caregiver
Altri numeri di identificazione dello studio
- 86875
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