- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03589508
Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard (GF_CARE)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: In-Person Sessions: ABCP_P
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)
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6 weekly sessions of alcohol prevention conducted in person.
|
Experimental: Video conference sessions: ABCP_T
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)
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6 weekly sessions of alcohol prevention conducted by video conference.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Drinking Days
Time Frame: Change from baseline at 2 months post session 1
|
Derived from Timeline Followback (TLFB)
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Change from baseline at 2 months post session 1
|
Percent Heavy Drinking Days
Time Frame: Change from baseline at 2 months post session 1
|
Derived from Timeline Followback (TLFB)
|
Change from baseline at 2 months post session 1
|
Mean Drinks Per Drinking Day
Time Frame: Change from baseline at 2 months post session 1
|
Derived from Timeline Followback (TLFB)
|
Change from baseline at 2 months post session 1
|
Attitude Items
Time Frame: Baseline and through study completion, about 8 weeks
|
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
Time Frame: Change from baseline at 2 months post Session 1
|
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
Time Frame: Change from baseline at 2 months post Session 1
|
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
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World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref
Time Frame: Change from baseline at 2 months post Session 1
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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
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Treatment Services Review
Time Frame: Weekly for up to 8 weeks
|
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.
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Weekly for up to 8 weeks
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Couple Satisfaction Inventory 16
Time Frame: Baseline and through study completion, about 8 weeks
|
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
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Perceived Social Support - Family
Time Frame: Baseline and through study completion, about 8 weeks
|
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
Time Frame: Baseline and through study completion, about 8 weeks
|
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.
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Baseline and through study completion, about 8 weeks
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Use of Prevention Skills
Time Frame: Baseline and through study completion, about 8 weeks
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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.
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Baseline and through study completion, about 8 weeks
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Outcomes Questionnaire (OQ) - 30
Time Frame: Baseline and through study completion, about 8 weeks
|
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
Time Frame: Baseline and through study completion, about 8 weeks
|
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.
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Baseline and through study completion, about 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intimate Partner Violence (IPV)
Time Frame: Change from baseline at 2 months post Session 1
|
Percent of sample with IPV as determined by scores on the Conflict Screener Form H.
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Change from baseline at 2 months post Session 1
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Medical History Questionnaire
Time Frame: Change from baseline at 2 months post Session 1
|
40 item self-report assessing presence of medical conditions currently and in the past.
Scores are calculated by summing individual item scores with possible scores ranging from 0 to 40.
Higher scores indicate greater number of medical problems.
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Change from baseline at 2 months post Session 1
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Traumatic Brain Injury (TBI)
Time Frame: Baseline
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Percent of sample with a TBI as determined by scores on the TBI Checklist.
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Baseline
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Traumatic Brain Injury (TBI) Checklist
Time Frame: Change from baseline at 4 months post Session 1
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Severity of TBI as determined by total scores on the TBI Checklist.
Scores are calculated by summing individual item scores with possible scores ranging from 8 to 88.
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Change from baseline at 4 months post Session 1
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End of Prevention Questionnaire
Time Frame: 2 months post Session 1
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Self-report questionnaire of helpfulness of therapy elements on a 7 point scale of -3 (greatly harmful), -2, -1, 0 (neutral), +1, +2, +3 (greatly helpful).
Total scores are calculated by averaging scores across individual items.
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2 months post Session 1
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Client Satisfaction Questionnaire
Time Frame: 2 months post Session 1
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8 item self-report assessing satisfaction with treatment.
Individual item scores are averaged to calculate a total score with possible scores ranging from 0 to 4. Two additional items assessed the client's ideal number of sessions and length of treatment, with scores ranging from 1 to 24 sessions and 1-12 months.
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2 months post Session 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth Epstein, PhD, UMass Worcester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AA023589
- R34AA023589 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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