- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05619185
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
April 5, 2024 updated by: 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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
744
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kat Nameth, BS
- Phone Number: 6505429699
- Email: knameth@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Kat Nameth, BS
- Phone Number: 650-542-9699
- Email: knameth@stanford.edu
-
Principal Investigator:
- Karen Osilla, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
Active Comparator: 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.
Other Names:
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.
Other Names:
|
Active Comparator: 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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concerned Partner Drinking Days
Time Frame: Baseline to 6 month follow-up
|
The CP primary outcome is drinking defined as number of drinking days in the past month
|
Baseline to 6 month follow-up
|
Concerned Partner Drinks per Episode
Time Frame: Baseline to 6 month follow-up
|
The CP primary outcome is drinking defined as number of drinks per episode in the past month
|
Baseline to 6 month follow-up
|
Service Member help-seeking
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mental health symptoms
Time Frame: Baseline to 6 month follow-up
|
Anxiety as measured by the global score on the Generalized Anxiety Disorder 7-item scale (GAD-7)
|
Baseline to 6 month follow-up
|
mental health symptoms
Time Frame: Baseline to 6 month follow-up
|
Depression as measured by the global score on the Patient Health Questionnaire 9-item (PHQ-9)
|
Baseline to 6 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2024
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
October 27, 2027
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
November 8, 2022
First Posted (Actual)
November 16, 2022
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67087
- 1R01AA030258 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There will be no IPD shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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