Engaging Family Members During Early SUD Treatment: A Hybrid Trial
The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder.
This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.
To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kat Nameth, MS
- Número de teléfono: 650-542-9699
- Correo electrónico: knameth@stanford.edu
Copia de seguridad de contactos de estudio
- Nombre: Kirsten Becker, MPH
- Número de teléfono: (866) 697-5620
- Correo electrónico: becker@rand.org
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92012
- Family Health Centers of San Diego
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Contacto:
- Joe Sepulveda, MD
- Número de teléfono: (619) 515-2300
- Correo electrónico: joes@fhcsd.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
FAMILY MEMBERS:
Inclusion Criteria:
- 18 years old or older
- A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
- Cohabitating with their loved one
- In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
- Not worried about potential physical harm from their loved one
- Report no illicit drug use in the past year
PATIENTS:
Inclusion Criteria:
- 18 years old or older
- In frequent contact with a family member (at least 3x/week) that they cohabitate with
- Have initiated substance use treatment in past 3 months
CLINIC PROVIDERS:
Inclusion Criteria:
- Counselor/Clinician providing care at our partner clinic for SUD
Exclusion Criteria (ALL):
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Aim 2: Arm 1
All 4 Engagement Strategies
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 2
Strategies 1-3
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Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 3
Strategies 1-2
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Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 4
Strategies 2-4
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Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 5
Strategies 3-4
|
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 6
Strategies 1 & 3
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Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 8
Strategies 1, 2 & 4
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Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 9
Strategies 2-3
|
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 10
Strategies 1, 3 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 12
Strategy 2
|
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 13
Strategy 3
|
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 14
Strategy 4
|
Engagement Strategy
|
|
Comparador activo: Aim 2: Arm 15
Strategy 1 & 4
|
Engagement Strategy
Engagement Strategy
|
|
Comparador de placebos: Aim 2: Arm 16
No Strategies
|
No engagement strategies
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Attendance
Periodo de tiempo: 2 months after baseline
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Attend at least 1 eINSPIRE session
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2 months after baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of Engagement Strategies
Periodo de tiempo: 6 months from enrollment
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Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
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6 months from enrollment
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Acceptability of Engagement Strategies
Periodo de tiempo: 6 months from enrollment
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Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
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6 months from enrollment
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Appropriateness of Engagement Strategies
Periodo de tiempo: 6 months from enrollment
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Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
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6 months from enrollment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen Osilla, 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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-86357
- 1R61DA064789-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
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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