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

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:

  1. if they are currently living with their partner,
  2. 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),
  3. if they are in a romantic relationship with the service member,
  4. if they have a computer they can use in a private area,
  5. if the CP and service member are at least 18 years of age,
  6. if their partner is currently an active duty service member,
  7. if the CP or service member has not attended couples or drug/alcohol counseling in the past 60 days,
  8. if the CP does not plan to separate from their partner in the next 60 days,
  9. if they feel their partner has a problem with their drinking, and
  10. if they do not endorse any domestic violence in the past year. -

Exclusion Criteria:

  1. if the CP plans to seek counseling in the next 90 days, and/or
  2. 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.

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

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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