- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073825
Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse (PC)
September 27, 2017 updated by: Karen Osilla, RAND
Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse
The purpose of this study is to adapt and pilot-test a web-based intervention intended to help concerned partners provide support to service members with alcohol misuse and to begin development of a service member module based on service member's input.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
U.S. military service members engaged in alcohol misuse are a vulnerable population with high unmet need.
Alcohol misuse is a stage of problem drinking that occurs before abuse and dependence, placing service members' partners and families at risk for serious consequences.
Unfortunately, existing military reporting policies may discourage service members from seeking help for fear of negative career consequences.
Service members report encouragement from their partners as the most prevalent facilitator of seeking care and individuals who change their drinking patterns most often cite partner support as the most helpful mechanism in supporting change.
Thus, targeting service members' partners using preventive interventions can be an important vehicle for preventing the progression to abuse and dependence.
A 3-year study is proposed to adapt and pilot-test a web-based intervention (WBI) intended to help concerned partners (CPs) provide support to service members with alcohol misuse and to begin development of a service member module based on service member's input.
First, an evidence-based intervention known as Community Reinforcement and Family Training (CRAFT) intervention will be adapted to the web.
The specific aims are as follows: Aim 1: Develop a 4-session web-based intervention (WBI) prototype and make iterative revisions based on feedback from 15-20 CPs.
Aim 2: Conduct a randomized controlled pilot-test of the finalized WBI (n=50) compared to delayed WBI (n=50), and evaluate the impact of the WBI on CP's reports of service member help-seeking (e.g., counseling, self-help, primary care, treatment) and drinking, and CP well-being and relationship satisfaction three months after the intervention.
Aim 3: Begin development of a follow-on WBI module for service members based on service member input and content evaluation.
Service members will be asked their intervention preferences and feedback on a proposed WBI for them.
This project is significant because it has the potential to benefit a large population of military service members who may be disproportionately affected by the current OEF/OIF/OND conflicts and whose drinking misuse would otherwise go undetected and untreated.
It also develops a new prevention model that does not rely on service members or partners attending a hospital or clinical facility to access care.
The proposed study is innovative because there are no CP-based preventive interventions addressing misuse.
This pilot study will inform the development of an R01 trial that evaluates a larger randomized study of a WBI for CPs with a follow-on intervention for service members.
Study Type
Interventional
Enrollment (Actual)
312
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 Locations
-
-
California
-
Santa Monica, California, United States, 90407
- RAND
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- if they are currently living with their partner,
- if they have had contact with their partner at least 40% of the time in the past 90 days (e.g., most of the evenings or most of the days in a given week),
- if they are in a romantic relationship with the service member,
- if they have a computer they can use in a private area,
- if the CP and service member are at least 18 years of age,
- if their partner is currently an active duty service member,
- if the CP or service member has not attended couples or drug/alcohol counseling in the past 60 days,
- if the CP does not plan to separate from their partner in the next 60 days,
- if they feel their partner has a problem with their drinking, and
- if they do not endorse any domestic violence in the past year. -
Exclusion Criteria:
- if the CP plans to seek counseling in the next 90 days, and/or
- reports feeling unsafe to discuss drinking with his/her partner -
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Web Brief Intervention (WBI)
4-session WBI
|
4-session WBI
|
No Intervention: Delayed-WBI
4-session WBI after follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceptions of Partner's Drinking
Time Frame: Three months after intervention
|
DNRF: "Consider a typical week during the past month (30 days).
How much alcohol, on average, (measured in number of drinks), do you think your partner had on each day of a typical week?"
|
Three months after intervention
|
Concern about Partner's Drinking
Time Frame: Three months after intervention
|
Thinking about your Partner's Drinking (TPD): http://www.sciencedirect.com/science/article/pii/S0306460313002517
|
Three months after intervention
|
Partner's readiness to change
Time Frame: Three months after intervention
|
On a scale from 0 to 10, how ready do you feel your partner is to change his/her drinking?
|
Three months after intervention
|
Partner help-seeking
Time Frame: Three months after intervention
|
On a scale from 0 to 10, how ready do you think your partner feels about seeking help for their drinking (for example, talking with a counselor or going to AA meetings regularly).
|
Three months after intervention
|
Relationship Quality
Time Frame: Three months after intervention
|
Quality Marriage Index (QMI): Norton, R. (1983).
Measuring marital quality: A critical look at the dependent variable.
Journal of Marriage and Family, 45, 141-151.
|
Three months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CP Depression and Anxiety
Time Frame: Three months after intervention
|
PHQ-8 and BAI
|
Three months after intervention
|
Family Environment
Time Frame: Three months after intervention
|
Family Environment Scale (FES)
|
Three months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen C Osilla, PhD, RAND
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Osilla KC, Pedersen ER, Gore K, Trail T, Howard SS. Study design to develop and pilot-test a web intervention for partners of military service members with alcohol misuse. Addict Sci Clin Pract. 2014 Sep 2;9(1):18. doi: 10.1186/1940-0640-9-18.
- Osilla KC, Pedersen ER, Tolpadi A, Howard SS, Phillips JL, Gore KL. The Feasibility of a Web Intervention for Military and Veteran Spouses Concerned About Their Partner's Alcohol Misuse. J Behav Health Serv Res. 2018 Jan;45(1):57-73. doi: 10.1007/s11414-016-9546-3.
- Pedersen, E. R., Osilla, K. C., Helmuth, E. D., Tolpadi, A., & Gore, K. (2017). Reaching Concerned Partners of Heavy Drinking Service Members and Veterans through Facebook. Military Behavioral Health, 5:3, 265-273, DOI: 10.1080/21635781.2017.1316804
- Rodriguez LM, Osilla KC, Trail TE, Gore KL, Pedersen ER. Alcohol Use Among Concerned Partners of Heavy Drinking Service Members and Veterans. J Marital Fam Ther. 2018 Apr;44(2):277-291. doi: 10.1111/jmft.12261. Epub 2017 Aug 7.
- Trail TE, Osilla KC, Rodriguez LM, Pedersen ER, Gore KL. Exploring the association between changes in partner behaviors, perceived service member drinking, and relationship quality: Secondary analysis of a web-based intervention for military partners. J Subst Abuse Treat. 2019 Mar;98:66-72. doi: 10.1016/j.jsat.2019.01.002. Epub 2019 Jan 3.
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
November 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
August 31, 2017
Study Registration Dates
First Submitted
February 20, 2014
First Submitted That Met QC Criteria
February 25, 2014
First Posted (Estimate)
February 27, 2014
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34AA023123 (U.S. NIH Grant/Contract)
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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