University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
NCT Number: NCT03589508
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01655, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for NG member:
Exclusion criteria
6 weekly sessions of alcohol prevention conducted in person.
6 weekly sessions of alcohol prevention conducted by video conference.
Time frame: Change from baseline at 2 months post session 1
Derived from Timeline Followback (TLFB)
Time frame: Change from baseline at 2 months post session 1
Derived from Timeline Followback (TLFB)
Time frame: Change from baseline at 2 months post session 1
Derived from Timeline Followback (TLFB)
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.
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.
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.
Time frame: Change from baseline at 2 months post Session 1
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).
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.
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.
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.
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.
Time frame: Baseline and through study completion, about 8 weeks
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.
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.
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.
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.
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.
Time frame: Baseline
Percent of sample with a TBI as determined by scores on the TBI Checklist.
Time frame: Change from baseline at 4 months post Session 1
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.
Time frame: 2 months post Session 1
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.
Time frame: 2 months post Session 1
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.
University of Massachusetts, Worcester
Other
Acronym: GF_CARE
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