Clinical trial NCT03589508: Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard
Official title: Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol; Harmful Use
Keywords: National Guard
Telehealth
Prevention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-07-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Specific Aim 1: To modify the existing, efficacious Alcohol Behavioral Couple Therapy (ABCT) manual into a 6-session prevention protocol, called Alcohol Behavioral Couple Prevention (ABCP) that will be developed for delivery via in-person and telehealth platforms. The goal of the new ABCP is for individuals or family dyads to learn to work together to minimize hazardous drinking in order to effectively address other problems often present among returning service members.

Specific Aim 2: To field test feasibility and preliminary efficacy of a prevention protocol using a successive cohort design. First, an in-person protocol will be tested with 4 National Guard (NG) members and then adapt and test the protocol for 4 NG members via an analog telehealth design. Again, the manual and accompanied materials will be revised.

Specific Aim 3: To conduct a small Randomized Controlled Trial (RCT) to compare 2 conditions with 22 NG Members in each: (1) In person (ABCP_P; 11 individual, 11 dyad), and (2) Telehealth (ABCP_T; 11 individual, 11 dyad).

Eligibility criteria: Inclusion Criteria for NG member:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Drinking Days
timeFrame: Change from baseline at 2 months post session 1
measure: Percent Heavy Drinking Days
timeFrame: Change from baseline at 2 months post session 1
measure: Mean Drinks Per Drinking Day
timeFrame: Change from baseline at 2 months post session 1
measure: Attitude Items
timeFrame: Baseline and through study completion, about 8 weeks
Secondary outcomes:
measure: Alcohol Expectancies Questionnaire 3
timeFrame: Change from baseline at 2 months post Session 1
measure: Coping Strategies Scale
timeFrame: Change from baseline at 2 months post Session 1
measure: World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref
timeFrame: Change from baseline at 2 months post Session 1
measure: Treatment Services Review
timeFrame: Weekly for up to 8 weeks
measure: Couple Satisfaction Inventory 16
timeFrame: Baseline and through study completion, about 8 weeks
measure: Perceived Social Support - Family
timeFrame: Baseline and through study completion, about 8 weeks
measure: Working Alliance Inventory Short Form
timeFrame: Baseline and through study completion, about 8 weeks
measure: Use of Prevention Skills
timeFrame: Baseline and through study completion, about 8 weeks
measure: Outcomes Questionnaire (OQ) - 30
timeFrame: Baseline and through study completion, about 8 weeks
measure: Copello Coping Questionnaire
timeFrame: Baseline and through study completion, about 8 weeks
Other outcomes:
measure: Intimate Partner Violence (IPV)
timeFrame: Change from baseline at 2 months post Session 1
measure: Medical History Questionnaire
timeFrame: Change from baseline at 2 months post Session 1
measure: Traumatic Brain Injury (TBI)
timeFrame: Baseline
measure: Traumatic Brain Injury (TBI) Checklist
timeFrame: Change from baseline at 4 months post Session 1
measure: End of Prevention Questionnaire
timeFrame: 2 months post Session 1
measure: Client Satisfaction Questionnaire
timeFrame: 2 months post Session 1
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: UMass Worcester
name: Elizabeth Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: