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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03589508
Acronym
GF_CARE
Enrollment
44
Registered
2018-07-18
Start date
2016-07-01
Completion date
2019-03-25
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol; Harmful Use

Keywords

National Guard, Telehealth, 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).

Interventions

BEHAVIORALIn-person sessions: ABCP_P

6 weekly sessions of alcohol prevention conducted in person.

BEHAVIORALVideo conference sessions: ABCP_T

6 weekly sessions of alcohol prevention conducted by video conference.

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent Drinking DaysChange from baseline at 2 months post session 1Derived from Timeline Followback (TLFB)
Attitude ItemsBaseline and through study completion, about 8 weeks6 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.
Mean Drinks Per Drinking DayChange from baseline at 2 months post session 1Derived from Timeline Followback (TLFB)
Percent Heavy Drinking DaysChange from baseline at 2 months post session 1Derived from Timeline Followback (TLFB)

Secondary

MeasureTime frameDescription
Couple Satisfaction Inventory 16Baseline and through study completion, about 8 weeks16 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.
Treatment Services ReviewWeekly for up to 8 weeksInterview 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.
Perceived Social Support - FamilyBaseline and through study completion, about 8 weeks20 item self report assessing perceived level of social support from family members. Higher scores indicate higher level of perceived social support.
Working Alliance Inventory Short FormBaseline and through study completion, about 8 weeks12-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.
Use of Prevention SkillsBaseline and through study completion, about 8 weeksSelf-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.
Outcomes Questionnaire (OQ) - 30Baseline and through study completion, about 8 weeks30 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.
Copello Coping QuestionnaireBaseline and through study completion, about 8 weeks30 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.
Alcohol Expectancies Questionnaire 3Change from baseline at 2 months post Session 140 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.
Coping Strategies ScaleChange from baseline at 2 months post Session 125-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.
World Health Organization Quality of Life (WHOQOL) Questionnaire - BrefChange from baseline at 2 months post Session 126-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).

Other

MeasureTime frameDescription
Client Satisfaction Questionnaire2 months post Session 18 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.
Medical History QuestionnaireChange from baseline at 2 months post Session 140 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.
End of Prevention Questionnaire2 months post Session 1Self-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.
Traumatic Brain Injury (TBI) ChecklistChange from baseline at 4 months post Session 1Severity 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.
Traumatic Brain Injury (TBI)BaselinePercent of sample with a TBI as determined by scores on the TBI Checklist.
Intimate Partner Violence (IPV)Change from baseline at 2 months post Session 1Percent of sample with IPV as determined by scores on the Conflict Screener Form H.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026