Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard

Study Overview
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Brief Summary
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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
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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).

Official Title
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Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard

Conditions
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Alcohol; Harmful Use

Intervention / Treatment
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* Behavioral: In-person sessions: ABCP_P
* Behavioral: Video conference sessions: ABCP_T


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Person Sessions: ABCP_P<br>In-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) | Behavioral: In-person sessions: ABCP_P<br>* 6 weekly sessions of alcohol prevention conducted in person.<br>|
| Experimental: Video conference sessions: ABCP_T<br>Video 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) | Behavioral: Video conference sessions: ABCP_T<br>* 6 weekly sessions of alcohol prevention conducted by video conference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Expectancies Questionnaire 3 | 40 item self-report questionnaire assessing thoughts, feelings and beliefs about alcohol. Sub scale scores are calculated by averaging item scores. Positive expectancy subscales are Global positive, Social and physical pleasure, Social expressiveness, Sexual enhancement, Power and aggression, and Tension reduction and relaxation. Negative expectancy sub scales are Cognitive and physical impairment, and Careless unconcern. Higher scores indicate greater expectancies. | Change from baseline at 2 months post Session 1 | 
| Coping Strategies Scale | 25-item brief measure assessing coping in alcohol-specific and non-alcohol situations. Scores range from 1-4 and higher scores indicate greater use of coping skills. Total score is calculated by averaging all values. | Change from baseline at 2 months post Session 1 | 
| World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref | 26-item self report assessing quality of life across 4 domains/subscales: Physical health, Psychological, Social relationships, Environment. The first two items measure quality of life and overall health and are examined separately, with scores ranging from 1-5. The four domain scores are calculated by averaging values and scores range from 1-5. Higher scores indicate higher quality of life within each domain. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100 (full scale measure). | Change from baseline at 2 months post Session 1 | 
| Treatment Services Review | Interview assessing quantity and type of services received (e.g., health, psychological) outside of study intervention. Total scores are calculated by summing the number of outside services used. Total scores have a minimum of 0 and no maximum value. | Weekly for up to 8 weeks | 
| Couple Satisfaction Inventory 16 | 16 item measure assessing satisfaction in couple relationship. Scores range from 0 to 81 and higher scores indicate higher levels of relationship satisfaction. Total score is calculated by summing all values. | Baseline and through study completion, about 8 weeks | 
| Perceived Social Support - Family | 20 item self report assessing perceived level of social support from family members. Higher scores indicate higher level of perceived social support. | Baseline and through study completion, about 8 weeks | 
| Working Alliance Inventory Short Form | 12-item self-report measure of the therapeutic alliance. Total scales are calculated by summing all values. Values range from 1-7 with total scores ranging from 12 to 84). Higher scores indicate greater alliance. | Baseline and through study completion, about 8 weeks | 
| Use of Prevention Skills | Self-report questionnaire assessing use of skills learned during prevention. Item scores range from 1-5 and a total score is calculated by summing all values. Higher scores indicate greater use of skills. | Baseline and through study completion, about 8 weeks | 
| Outcomes Questionnaire (OQ) - 30 | 30 item self-report questionnaire assessing past week psychological well-being. Scores are summed across items and range from 0 to 120, with higher scores indicating worse psychological well-being. | Baseline and through study completion, about 8 weeks | 
| Copello Coping Questionnaire | 30 item self-report assessing partner alcohol-related coping skill use. Total score is calculated by summing the values from each item and scores range from 0-90 with higher scored indicating greater use of coping strategies. | Baseline and through study completion, about 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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National Guard, Telehealth, Prevention