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Uma avaliação SMART de um tratamento de AUD adaptável baseado na Web para membros do serviço e seus parceiros

14 de outubro de 2026 atualizado 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.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

744

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.

Outros nomes:
  • WBI
  • Parceiros Conectados
  • Intervenção baseada na 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.

Outros nomes:
  • Sessões telefônicas de Reforço Comunitário e Treinamento 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.

Outros nomes:
  • Manual de Reforço Comunitário e Treinamento Familiar (CRAFT)
Comparador Ativo: 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.

Outros nomes:
  • WBI
  • Parceiros Conectados
  • Intervenção baseada na 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.

Outros nomes:
  • Sessões telefônicas de Reforço Comunitário e Treinamento Familiar (CRAFT)
Comparador Ativo: 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.

Outros nomes:
  • WBI
  • Parceiros Conectados
  • Intervenção baseada na 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.

Outros nomes:
  • Manual de Reforço Comunitário e Treinamento Familiar (CRAFT)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
CP Depression
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

14 de junho de 2024

Conclusão Primária (Estimado)

31 de agosto de 2027

Conclusão do estudo (Estimado)

31 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de novembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de novembro de 2022

Primeira postagem (Real)

16 de novembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 67087
  • 1R01AA030258 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

There will be no IPD shared

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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