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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jeremy Giberson
- Número de teléfono: 650-723-5814
- Correo electrónico: jgiberso@stanford.edu
Copia de seguridad de contactos de estudio
- Nombre: Sahrish Masood
- Correo electrónico: sahrishm@stanford.edu
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94304
- Stanford University
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Investigador principal:
- Laura Simons, PhD
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Contacto:
- Jeremy Giberson
- Número de teléfono: 650-723-5814
- Correo electrónico: jgiberso@stanford.edu
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Contacto:
- Sahrish Masood
- Correo electrónico: sahrishm@stanford.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Escala de retroalimentación del programa
Periodo de tiempo: Inmediatamente publique la clase
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La Escala de retroalimentación del programa evalúa el acuerdo de los participantes con siete afirmaciones que indican su aceptabilidad y viabilidad percibidas según una escala (puntuación de 0 = "realmente en desacuerdo" a 4 = "realmente de acuerdo") con una puntuación más alta que indica retroalimentación positiva y dos preguntas abiertas.
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Inmediatamente publique la clase
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Treatment Expectancy and Credibility: Caregiver Version
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Adult Responses to Children's Symptoms (ARCS) - Protect Subscale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laura Simons, PhD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Enfermedades Neuromusculares
- Enfermedades reumáticas
- Signos y Síntomas Digestivos
- Enfermedades del Sistema Nervioso Periférico
- Enfermedades del sistema nervioso autónomo
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor abdominal
- Dolor musculoesquelético
- Fibromialgia
- Dolor crónico
- Neuralgia
- Síndromes de dolor regional complejo
- Instalaciones de atención médica Fuerza laboral y servicios
- Personal de salud
- Cuidadores
Otros números de identificación del estudio
- 86875
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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