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Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse (PC)

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web Brief Intervention (WBI)
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring Computer-assisted interventions, Alcohol use disorders, At-risk drinking, Spouses, Military, Brief Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • RAND

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web Brief Intervention (WBI)

Delayed-WBI

Arm Description

4-session WBI

4-session WBI after follow-up

Outcomes

Primary Outcome Measures

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?"
Concern about Partner's Drinking
Thinking about your Partner's Drinking (TPD): http://www.sciencedirect.com/science/article/pii/S0306460313002517
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?
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).
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.

Secondary Outcome Measures

CP Depression and Anxiety
PHQ-8 and BAI
Family Environment
Family Environment Scale (FES)

Full Information

First Posted
February 20, 2014
Last Updated
September 27, 2017
Sponsor
RAND
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02073825
Brief Title
Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse
Acronym
PC
Official Title
Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Computer-assisted interventions, Alcohol use disorders, At-risk drinking, Spouses, Military, Brief Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web Brief Intervention (WBI)
Arm Type
Experimental
Arm Description
4-session WBI
Arm Title
Delayed-WBI
Arm Type
No Intervention
Arm Description
4-session WBI after follow-up
Intervention Type
Behavioral
Intervention Name(s)
Web Brief Intervention (WBI)
Intervention Description
4-session WBI
Primary Outcome Measure Information:
Title
Perceptions of Partner's Drinking
Description
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?"
Time Frame
Three months after intervention
Title
Concern about Partner's Drinking
Description
Thinking about your Partner's Drinking (TPD): http://www.sciencedirect.com/science/article/pii/S0306460313002517
Time Frame
Three months after intervention
Title
Partner's readiness to change
Description
On a scale from 0 to 10, how ready do you feel your partner is to change his/her drinking?
Time Frame
Three months after intervention
Title
Partner help-seeking
Description
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).
Time Frame
Three months after intervention
Title
Relationship Quality
Description
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.
Time Frame
Three months after intervention
Secondary Outcome Measure Information:
Title
CP Depression and Anxiety
Description
PHQ-8 and BAI
Time Frame
Three months after intervention
Title
Family Environment
Description
Family Environment Scale (FES)
Time Frame
Three months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen C Osilla, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAND
City
Santa Monica
State/Province
California
ZIP/Postal Code
90407
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25179672
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.
Results Reference
background
PubMed Identifier
28039559
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
28782116
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.
Results Reference
result
PubMed Identifier
30665606
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.
Results Reference
derived

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

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