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

Alcohol; Harmful Use Clinical Trial

— GF_CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589508
• Other study ID #: AA023589
• Secondary ID: R34AA023589
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: March 25, 2019

Study information

• Verified date: May 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol; Harmful Use

Intervention

Behavioral:
• In-person sessions: ABCP_P
6 weekly sessions of alcohol prevention conducted in person.
• Video conference sessions: ABCP_T
6 weekly sessions of alcohol prevention conducted by video conference.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intimate Partner Violence (IPV)	Percent of sample with IPV as determined by scores on the Conflict Screener Form H.	Change from baseline at 2 months post Session 1
Other	Medical History Questionnaire	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.	Change from baseline at 2 months post Session 1
Other	Traumatic Brain Injury (TBI)	Percent of sample with a TBI as determined by scores on the TBI Checklist.	Baseline
Other	Traumatic Brain Injury (TBI) Checklist	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.	Change from baseline at 4 months post Session 1
Other	End of Prevention Questionnaire	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.	2 months post Session 1
Other	Client Satisfaction Questionnaire	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.	2 months post Session 1
Primary	Percent Drinking Days	Derived from Timeline Followback (TLFB)	Change from baseline at 2 months post session 1
Primary	Percent Heavy Drinking Days	Derived from Timeline Followback (TLFB)	Change from baseline at 2 months post session 1
Primary	Mean Drinks Per Drinking Day	Derived from Timeline Followback (TLFB)	Change from baseline at 2 months post session 1
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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