A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners

NCT ID: NCT05619185

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Abuse Alcohol Use Disorder Alcohol Drinking Relations, Interpersonal Military Family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

CRAFT Web-Based Intervention

Intervention Type BEHAVIORAL

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.

Phone-Based CRAFT

Intervention Type BEHAVIORAL

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.

CRAFT Workbook

Intervention Type BEHAVIORAL

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.

Control

Those randomized to CONTROL will complete a self-guided intervention

Group Type ACTIVE_COMPARATOR

Gottman Self-Guided Resources

Intervention Type BEHAVIORAL

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.

Phone Based CRAFT

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

Group Type EXPERIMENTAL

CRAFT Web-Based Intervention

Intervention Type BEHAVIORAL

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.

Phone-Based CRAFT

Intervention Type BEHAVIORAL

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.

CRAFT Workbook

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

Group Type ACTIVE_COMPARATOR

CRAFT Web-Based Intervention

Intervention Type BEHAVIORAL

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.

CRAFT Workbook

Intervention Type BEHAVIORAL

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.

Interventions

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CRAFT 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.

Intervention Type BEHAVIORAL

Phone-Based CRAFT

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.

Intervention Type BEHAVIORAL

CRAFT Workbook

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.

Intervention Type BEHAVIORAL

Gottman Self-Guided Resources

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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WBI Partners Connect Web-based intervention (WBI) Community Reinforcement and Family Training (CRAFT) phone sessions Community Reinforcement and Family Training (CRAFT) workbook

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role collaborator

RAND

OTHER

Sponsor Role collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Karen Osilla

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kat Nameth, BS

Role: CONTACT

6505429699

Facility Contacts

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Kat Nameth, BS

Role: primary

650-542-9699

References

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Osilla KC, Gore KL, Pedersen ER, Hummer JF, DeYoreo M, Manuel JK, McKay JR, Kim JP, Nameth K. Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners. Contemp Clin Trials. 2023 Oct;133:107324. doi: 10.1016/j.cct.2023.107324. Epub 2023 Aug 29.

Reference Type DERIVED
PMID: 37652360 (View on PubMed)

Other Identifiers

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1R01AA030258

Identifier Type: NIH

Identifier Source: secondary_id

View Link

67087

Identifier Type: -

Identifier Source: org_study_id

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