Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard
GF_CARE
2 other identifiers
interventional
44
1 country
1
Brief Summary
The purpose of this project is to develop and test indicated prevention intervention to harness support and health promoting endeavors to address use of alcohol to cope with reintegration challenges in Massachusetts National Guard (MANG) service members.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2019
CompletedMay 23, 2019
May 1, 2019
2.7 years
June 8, 2018
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percent Drinking Days
Derived from Timeline Followback (TLFB)
Change from baseline at 2 months post session 1
Percent Heavy Drinking Days
Derived from Timeline Followback (TLFB)
Change from baseline at 2 months post session 1
Mean Drinks Per Drinking Day
Derived from Timeline Followback (TLFB)
Change from baseline at 2 months post session 1
Attitude Items
6 item self-report questionnaire assessing attitudes toward drinking under different circumstances. Item scores were summed to calculate total scores, with scores ranging from 6 to 24. Higher scores indicate greater attitudes about acceptability of drinking across situations.
Baseline and through study completion, about 8 weeks
Secondary Outcomes (10)
Alcohol Expectancies Questionnaire 3
Change from baseline at 2 months post Session 1
Coping Strategies Scale
Change from baseline at 2 months post Session 1
World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref
Change from baseline at 2 months post Session 1
Treatment Services Review
Weekly for up to 8 weeks
Couple Satisfaction Inventory 16
Baseline and through study completion, about 8 weeks
- +5 more secondary outcomes
Other Outcomes (6)
Intimate Partner Violence (IPV)
Change from baseline at 2 months post Session 1
Medical History Questionnaire
Change from baseline at 2 months post Session 1
Traumatic Brain Injury (TBI)
Baseline
- +3 more other outcomes
Study Arms (2)
In-Person Sessions: ABCP_P
EXPERIMENTALIn-person therapy sessions: 6 Weekly Prevention Session conducted in person (half of participants will attend alone, half of participants will attend with a significant other)
Video conference sessions: ABCP_T
EXPERIMENTALVideo conference therapy sessions: 6 Weekly Prevention Session conducted using videoconference (half of participants will attend alone, half of participants will attend with a significant other)
Interventions
6 weekly sessions of alcohol prevention conducted in person.
6 weekly sessions of alcohol prevention conducted by video conference.
Eligibility Criteria
You may qualify if:
- Age 18 and older and a member of the MANG.
- Have a SO or trusted friend who is 18 or older
- Service member endorsed one item on the 10-item Alcohol Use Disorders Identification Test within their lifetime
You may not qualify if:
- unable to give consent
- Prisoners
- Principal Investigators determined the participant requires a higher level of care (based on unstabilized psychiatric disorder, and/or high drinking or drug use severity, and/or inability to attend to adl's and/or agitated behavior
- Service Member is unable to read or comprehend English at the 7th grade education level
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Epstein, PhD
UMass Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 8, 2018
First Posted
July 18, 2018
Study Start
July 1, 2016
Primary Completion
March 25, 2019
Study Completion
March 25, 2019
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared with researchers outside of the core study team.