Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse

Alcohol Abuse Clinical Trial

— PC  

Official title:

Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073825
• Other study ID #: R34AA023123
• Secondary ID: R34AA023123
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: September 27, 2017
• Start date: November 2014
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: August 31, 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

Behavioral:
• Web Brief Intervention (WBI)
4-session WBI

Locations

Country	Name	City	State
United States	RAND	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. 2016 Dec 30. doi: 10.1007/s11414-016-9546-3. [Epub ahead of print] — View Citation

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. 2017 Aug 7. doi: 10.1111/jmft.12261. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceptions of Partner's Drinking	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
Primary	Concern about Partner's Drinking	Thinking about your Partner's Drinking (TPD): http://www.sciencedirect.com/science/article/pii/S0306460313002517	Three months after intervention
Primary	Partner's readiness to change	On a scale from 0 to 10, how ready do you feel your partner is to change his/her drinking?	Three months after intervention
Primary	Partner help-seeking	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
Primary	Relationship Quality	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	CP Depression and Anxiety	PHQ-8 and BAI	Three months after intervention
Secondary	Family Environment	Family Environment Scale (FES)	Three months after intervention