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Una valutazione SMART di un trattamento AUD adattivo basato sul Web per i membri del servizio e i loro partner

14 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

744

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • California
      • Palo Alto, California, Stati Uniti, 94305
        • Reclutamento
        • Stanford University
        • Contatto:
        • Investigatore principale:
          • Karen Osilla, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Altri nomi:
  • WBI
  • Partner Connect
  • Intervento basato sul 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.

Altri nomi:
  • Sessioni telefoniche di Community Reinforcement and Family Training (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.

Altri nomi:
  • Cartella di lavoro per il rafforzamento della comunità e la formazione familiare (CRAFT).
Comparatore attivo: 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.

Sperimentale: 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.

Altri nomi:
  • WBI
  • Partner Connect
  • Intervento basato sul 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.

Altri nomi:
  • Sessioni telefoniche di Community Reinforcement and Family Training (CRAFT).
Comparatore attivo: 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.

Altri nomi:
  • WBI
  • Partner Connect
  • Intervento basato sul 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.

Altri nomi:
  • Cartella di lavoro per il rafforzamento della comunità e la formazione familiare (CRAFT).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CP Depression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 giugno 2024

Completamento primario (Stimato)

31 agosto 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

2 novembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

8 novembre 2022

Primo Inserito (Effettivo)

16 novembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 67087
  • 1R01AA030258 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

There will be no IPD shared

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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