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En SMART evaluering af en adaptiv webbaseret AUD-behandling for servicemedlemmer og deres partnere

14. oktober 2026 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

744

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • California
      • Palo Alto, California, Forenede Stater, 94305
        • Rekruttering
        • Stanford University
        • Kontakt:
        • Ledende efterforsker:
          • Karen Osilla, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Andre navne:
  • WBI
  • Partners Connect
  • Web-baseret intervention (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.

Andre navne:
  • Samfundsforstærkning og familietræning (CRAFT) telefonsessioner

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.

Andre navne:
  • Arbejdsbog om lokalforstærkning og familietræning (CRAFT).
Aktiv komparator: 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.

Eksperimentel: 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.

Andre navne:
  • WBI
  • Partners Connect
  • Web-baseret intervention (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.

Andre navne:
  • Samfundsforstærkning og familietræning (CRAFT) telefonsessioner
Aktiv komparator: 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.

Andre navne:
  • WBI
  • Partners Connect
  • Web-baseret intervention (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.

Andre navne:
  • Arbejdsbog om lokalforstærkning og familietræning (CRAFT).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CP Depression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. juni 2024

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

2. november 2022

Først indsendt, der opfyldte QC-kriterier

8. november 2022

Først opslået (Faktiske)

16. november 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 67087
  • 1R01AA030258 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There will be no IPD shared

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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