Back to resultsA SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Primary Purpose
Alcohol Abuse, Alcohol Use Disorder, Alcohol Drinking
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRAFT Web-Based Intervention
Phone-Based CRAFT
CRAFT Workbook
Gottman Self-Guided Resources
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse focused on measuring military, alcohol, drinking, substance use
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Intervention
Control
Phone Based CRAFT
CRAFT Workbook
Arm Description
Those randomized to the CRAFT intervention will receive a web-based intervention
Those randomized to CONTROL will complete a self-guided intervention
If a member of the recruited dyad does not respond, then participants will be randomized to receive phone-based CRAFT
If a member of the recruited dyad does not respond, then participants will be randomized to receive a CRAFT workbook
Outcomes
Primary Outcome Measures
Concerned Partner Drinking Days
The CP primary outcome is drinking defined as number of drinking days in the past month
Concerned Partner Drinks per Episode
The CP primary outcome is drinking defined as number of drinks per episode in the past month
Service Member help-seeking
Completion of the personalized normalized feedback (PNF) component of the intervention as a signal of increase help-seeking behavior
Secondary Outcome Measures
mental health symptoms
Anxiety as measured by the global score on the Generalized Anxiety Disorder 7-item scale (GAD-7)
mental health symptoms
Depression as measured by the global score on the Patient Health Questionnaire 9-item (PHQ-9)
Full Information
NCT ID
NCT05619185
First Posted
November 2, 2022
Last Updated
July 12, 2023
Sponsor
Stanford University
Collaborators
University of Southern California, RAND, Northern California Institute of Research and Education, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05619185
Brief Title
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Official Title
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
October 27, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of Southern California, RAND, Northern California Institute of Research and Education, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Use Disorder, Alcohol Drinking, Relations, Interpersonal, Military Family
Keywords
military, alcohol, drinking, substance use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
744 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Those randomized to the CRAFT intervention will receive a web-based intervention
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Those randomized to CONTROL will complete a self-guided intervention
Arm Title
Phone Based CRAFT
Arm Type
Experimental
Arm Description
If a member of the recruited dyad does not respond, then participants will be randomized to receive phone-based CRAFT
Arm Title
CRAFT Workbook
Arm Type
Active Comparator
Arm Description
If a member of the recruited dyad does not respond, then participants will be randomized to receive a CRAFT workbook
Intervention Type
Behavioral
Intervention Name(s)
CRAFT Web-Based Intervention
Other Intervention Name(s)
WBI, Partners Connect, Web-based intervention (WBI)
Intervention Description
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
Intervention Name(s)
Phone-Based CRAFT
Other Intervention Name(s)
Community Reinforcement and Family Training (CRAFT) phone sessions
Intervention Description
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
Intervention Name(s)
CRAFT Workbook
Other Intervention Name(s)
Community Reinforcement and Family Training (CRAFT) workbook
Intervention Description
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
Intervention Name(s)
Gottman Self-Guided Resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concerned Partner Drinking Days
Description
The CP primary outcome is drinking defined as number of drinking days in the past month
Time Frame
Baseline to 6 month follow-up
Title
Concerned Partner Drinks per Episode
Description
The CP primary outcome is drinking defined as number of drinks per episode in the past month
Time Frame
Baseline to 6 month follow-up
Title
Service Member help-seeking
Description
Completion of the personalized normalized feedback (PNF) component of the intervention as a signal of increase help-seeking behavior
Time Frame
Baseline to 6 month
Secondary Outcome Measure Information:
Title
mental health symptoms
Description
Anxiety as measured by the global score on the Generalized Anxiety Disorder 7-item scale (GAD-7)
Time Frame
Baseline to 6 month follow-up
Title
mental health symptoms
Description
Depression as measured by the global score on the Patient Health Questionnaire 9-item (PHQ-9)
Time Frame
Baseline to 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kat Nameth, BS
Phone
6505429699
Email
knameth@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kat Nameth, BS
Phone
650-542-9699
Email
knameth@stanford.edu
First Name & Middle Initial & Last Name & Degree
Karen Osilla, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There will be no IPD shared
Learn more about this trial
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
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