Clinical trial NCT02073825: Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse
Official title: Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Computer-assisted interventions
Alcohol use disorders
At-risk drinking
Spouses
Military
Brief Intervention
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-02-27
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Perceptions of Partner's Drinking
timeFrame: Three months after intervention
measure: Concern about Partner's Drinking
timeFrame: Three months after intervention
measure: Partner's readiness to change
timeFrame: Three months after intervention
measure: Partner help-seeking
timeFrame: Three months after intervention
measure: Relationship Quality
timeFrame: Three months after intervention
Secondary outcomes:
measure: CP Depression and Anxiety
timeFrame: Three months after intervention
measure: Family Environment
timeFrame: Three months after intervention
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: RAND
state: California
Study officials:
affiliation: RAND
name: Karen C Osilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2018 Jan;45(1):57-73. doi: 10.1007/s11414-016-9546-3.
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
citation: 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.
citation: 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.