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Una evaluación SMART de un tratamiento adaptativo AUD basado en la web para miembros del servicio y sus socios

14 de octubre de 2026 actualizado por: Karen Osilla, Stanford University

The purpose of this study is to evaluate the efficacy of an adaptive web intervention (Partners Connect) on military spouse drinking behaviors (CPs) and service member help-seeking (SMs). The investigators want to identify for whom this intervention is most efficacious and on what drinking behaviors and mechanisms. The investigators hypothesize that the intervention will reduce concerned partner drinking and increase service member help-seeking, compared to website resources, and that phone-based CRAFT will increase help-seeking behaviors, compared to those who are guided via a CRAFT workbook.

Our outcome is to evaluate the efficacy of an adaptive CP intervention on CP well-being and service member help-seeking.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

744

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • California
      • Palo Alto, California, Estados Unidos, 94305
        • Reclutamiento
        • Stanford University
        • Contacto:
        • Investigador principal:
          • Karen Osilla, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • at least 18 years of age;
  • be living together with their partner, with no plans to change that status in the next 2 months;
  • not be in the military themselves (to reduce concerns about mandated reporting of alcohol use);
  • score ≥4 on the AUDIT-C for females or ≥5 for males/other;
  • respond yes to "Do you feel safe in your current relationship?" from the Partner Violence Screen;
  • report not currently being in mental health or alcohol treatment (CP and SM)
  • understand English fluently,
  • be willing to try an online program to address risky drinking.

We require cohabitating CPs and SMs with no anticipated changes in the next two months to ensure close contact and opportunity to practice new skills, and those who would feel safe participating.

Exclusion Criteria:

  • CPs in substance use treatment or their SM was in treatment in the last three months;
  • does not feel safe in the current relationship;
  • does not understand English fluently;
  • has an impaired capacity (cognitive, visual, or hearing);
  • is not cohabitating with their SM

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention

Those randomized to the CRAFT intervention will receive a web-based intervention

Session 1 addresses CPs' mental health issues and drinking. CPs select reasons why they are seeking help and steps they will take towards those goals. Session 2 is focused on improving their relationship through communication exercises. Session 3 is focused on functional analysis of their partner's drinking, and how to positively reinforce their partner's sobriety and negatively reinforce their drinking. Finally, Session 4 focuses on continuing self-care and talking with their partner about their concerns while interacting with them in healthy ways. The WBI contains audio, video, text, and exercises that utilize digital storytelling and vignettes to convey teaching points - a method utilized by the military to address stigma and increase treatment utilization. Actresses portrayed different experiences that the CP may be going through and modeled skills. CPs clicked on the vignette that they most connected with and followed that character across all the sessions.

Otros nombres:
  • WBI
  • Conexión de socios
  • Intervención basada en la web (WBI)

The phone-based CRAFT intervention consists of six individual sessions with a CRAFT clinician that will explore what they learned from the WBI and additional skills they need. Session content includes positive reinforcement of non-drinking SM behaviors, refraining from interfering in SM's consequences of alcohol use, communication skills, and self-care.

Otros nombres:
  • Sesiones telefónicas de refuerzo comunitario y capacitación familiar (CRAFT)

The self-directed CRAFT workbook Table 1.Partners Connect WBI has a parent and partner version that uses CRAFT to help the CP help with understanding, self-care, communication, and actions (e.g., how to react when a partner has been using substances and when they have not been using substances, how to talk to partner so that they are more likely to be heard) and includes more information about communicating than the WBI and several interactive worksheets.

Otros nombres:
  • Libro de trabajo de refuerzo comunitario y capacitación familiar (CRAFT, por sus siglas en inglés)
Comparador activo: Control

Those randomized to CONTROL will complete a self-guided intervention

To match time spent reviewing the website, CPs will receive an orientation guide that includes the website URL and a 4-week guide for how they can navigate this website for 20-30 minutes per week (e.g., read article "'It's Not My Fault!': Why Defensiveness is Damaging" and write down one tool to dissolve defensiveness you're willing to try). We will send reminder emails each week to visit the website and include questions in the emails and our first online follow-up survey asking CPs approximately how many times they visited the website and how long they spent viewing content on the website. Reminder emails will be programmed such that CPs get directed automatically to the website if the CP notes no time spent on it.

Experimental: Phone Based CRAFT

If a member of the recruited dyad does not respond, then participants will be randomized to receive phone-based CRAFT

Session 1 addresses CPs' mental health issues and drinking. CPs select reasons why they are seeking help and steps they will take towards those goals. Session 2 is focused on improving their relationship through communication exercises. Session 3 is focused on functional analysis of their partner's drinking, and how to positively reinforce their partner's sobriety and negatively reinforce their drinking. Finally, Session 4 focuses on continuing self-care and talking with their partner about their concerns while interacting with them in healthy ways. The WBI contains audio, video, text, and exercises that utilize digital storytelling and vignettes to convey teaching points - a method utilized by the military to address stigma and increase treatment utilization. Actresses portrayed different experiences that the CP may be going through and modeled skills. CPs clicked on the vignette that they most connected with and followed that character across all the sessions.

Otros nombres:
  • WBI
  • Conexión de socios
  • Intervención basada en la web (WBI)

The phone-based CRAFT intervention consists of six individual sessions with a CRAFT clinician that will explore what they learned from the WBI and additional skills they need. Session content includes positive reinforcement of non-drinking SM behaviors, refraining from interfering in SM's consequences of alcohol use, communication skills, and self-care.

Otros nombres:
  • Sesiones telefónicas de refuerzo comunitario y capacitación familiar (CRAFT)
Comparador activo: CRAFT Workbook

If a member of the recruited dyad does not respond, then participants will be randomized to receive a CRAFT workbook

Session 1 addresses CPs' mental health issues and drinking. CPs select reasons why they are seeking help and steps they will take towards those goals. Session 2 is focused on improving their relationship through communication exercises. Session 3 is focused on functional analysis of their partner's drinking, and how to positively reinforce their partner's sobriety and negatively reinforce their drinking. Finally, Session 4 focuses on continuing self-care and talking with their partner about their concerns while interacting with them in healthy ways. The WBI contains audio, video, text, and exercises that utilize digital storytelling and vignettes to convey teaching points - a method utilized by the military to address stigma and increase treatment utilization. Actresses portrayed different experiences that the CP may be going through and modeled skills. CPs clicked on the vignette that they most connected with and followed that character across all the sessions.

Otros nombres:
  • WBI
  • Conexión de socios
  • Intervención basada en la web (WBI)

The self-directed CRAFT workbook Table 1.Partners Connect WBI has a parent and partner version that uses CRAFT to help the CP help with understanding, self-care, communication, and actions (e.g., how to react when a partner has been using substances and when they have not been using substances, how to talk to partner so that they are more likely to be heard) and includes more information about communicating than the WBI and several interactive worksheets.

Otros nombres:
  • Libro de trabajo de refuerzo comunitario y capacitación familiar (CRAFT, por sus siglas en inglés)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
CP Depression
Periodo de tiempo: Baseline to 6 month follow-up

Depression as measured by the global score on the Patient Health Questionnaire 9-item (PHQ-9). Scores range from 0 - 27. Higher scores indicate more severe depression.

Baseline to 6 month follow-up
CP Anxiety
Periodo de tiempo: Baseline to 6 month follow-up

Anxiety as measured by the global score on the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores range from 0 - 21. Higher scores indicate more severe anxiety.

Baseline to 6 month follow-up
Service Member help-seeking
Periodo de tiempo: Baseline to 6 month

Completion of the personalized normalized feedback (PNF) component of the intervention as a signal of increase help-seeking behavior

Baseline to 6 month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de junio de 2024

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2022

Publicado por primera vez (Actual)

16 de noviembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 67087
  • 1R01AA030258 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There will be no IPD shared

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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