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Trial record 1 of 1 for:    NCT02073825
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Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse (PC)

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ClinicalTrials.gov Identifier: NCT02073825
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Karen Osilla, RAND

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Behavioral: Web Brief Intervention (WBI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse
Study Start Date : November 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : August 31, 2017

Arm Intervention/treatment
Experimental: Web Brief Intervention (WBI)
4-session WBI
Behavioral: Web Brief Intervention (WBI)
4-session WBI

No Intervention: Delayed-WBI
4-session WBI after follow-up



Primary Outcome Measures :
  1. 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?"

  2. 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

  3. 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?

  4. 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).

  5. 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.


Secondary Outcome Measures :
  1. CP Depression and Anxiety [ Time Frame: Three months after intervention ]
    PHQ-8 and BAI

  2. Family Environment [ Time Frame: Three months after intervention ]
    Family Environment Scale (FES)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073825


Locations
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United States, California
RAND
Santa Monica, California, United States, 90407
Sponsors and Collaborators
RAND
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Karen C Osilla, PhD RAND

Publications of Results:
Other Publications:
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Responsible Party: Karen Osilla, Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT02073825     History of Changes
Other Study ID Numbers: R34AA023123 ( U.S. NIH Grant/Contract )
R34AA023123 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Karen Osilla, RAND:
Computer-assisted interventions
Alcohol use disorders
At-risk drinking
Spouses
Military
Brief Intervention

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs