Alcohol; Harmful UseGF_CARENCT03589508
Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard
A study testing In-person sessions: ABCP_P and Video conference sessions: ABCP_T in people with Alcohol; Harmful Use, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol; Harmful Use
- What is being tested?
- In-person sessions: ABCP_P and Video conference sessions: ABCP_T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 25 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the 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).
- Conditions
- Alcohol; Harmful Use
- Being tested
- In-person sessions: ABCP_P, Video conference sessions: ABCP_T
- Keywords
- National Guard, Telehealth, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person sessions: ABCP_PBehavioural
6 weekly sessions of alcohol prevention conducted in person.
Video conference sessions: ABCP_TBehavioural
6 weekly sessions of alcohol prevention conducted by video conference.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Sessions: ABCP_P | Experimental | 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) Receives: Behavioral: In-person sessions: ABCP_P |
| Video conference sessions: ABCP_T | Experimental | 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) Receives: Behavioral: Video conference sessions: ABCP_T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Drinking Days
Derived from Timeline Followback (TLFB)
Measured: Change from baseline at 2 months post session 1
Percent Heavy Drinking Days
Derived from Timeline Followback (TLFB)
Measured: Change from baseline at 2 months post session 1
Mean Drinks Per Drinking Day
Derived from Timeline Followback (TLFB)
Measured: 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.
Measured: Baseline and through study completion, about 8 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and through study completion, about 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Jul 2016
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol; Harmful UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Elizabeth Epstein, University of Massachusetts, Worcester
- Investigators
- Elizabeth Epstein, PhD, Principal investigator, UMass Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589508
- Sponsor's protocol ID
- AA023589
- Other IDs
- R34AA023589
- Acronym
- GF_CARE
- Status last verified
- May 2019
- First submitted
- 8 Jun 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with researchers outside of the core study team.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard
- ClinicalTrials.gov ID
- NCT03589508
- Acronym / sponsor ID
- GF_CARE / AA023589
- Conditions
- Alcohol; Harmful Use
- Keywords
- National Guard, Telehealth, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Sessions: ABCP_P | Experimental | Behavioral: In-person sessions: ABCP_PIn-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) |
| Video conference sessions: ABCP_T | Experimental | Behavioral: Video conference sessions: ABCP_TVideo 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person sessions: ABCP_P6 weekly sessions of alcohol prevention conducted in person. | Behavioural | In-Person Sessions: ABCP_P |
| Video conference sessions: ABCP_T6 weekly sessions of alcohol prevention conducted by video conference. | Behavioural | Video conference sessions: ABCP_T |
Primary outcome
Percent Drinking Days
Time frame: Change from baseline at 2 months post session 1
Derived from Timeline Followback (TLFB)
Percent Heavy Drinking Days
Time frame: Change from baseline at 2 months post session 1
Derived from Timeline Followback (TLFB)
Mean Drinks Per Drinking Day
Time frame: Change from baseline at 2 months post session 1
Derived from Timeline Followback (TLFB)
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.
10 secondary outcomes
Alcohol Expectancies Questionnaire 3
Time frame: Change from baseline at 2 months post Session 1
Coping Strategies Scale
Time frame: Change from baseline at 2 months post Session 1
World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref
Time frame: Change from baseline at 2 months post Session 1
Treatment Services Review
Time frame: Weekly for up to 8 weeks
Couple Satisfaction Inventory 16
Time frame: Baseline and through study completion, about 8 weeks
Perceived Social Support - Family
Time frame: Baseline and through study completion, about 8 weeks
Working Alliance Inventory Short Form
Time frame: Baseline and through study completion, about 8 weeks
Use of Prevention Skills
Time frame: Baseline and through study completion, about 8 weeks
Outcomes Questionnaire (OQ) - 30
Time frame: Baseline and through study completion, about 8 weeks
Copello Coping Questionnaire
Time frame: Baseline and through study completion, about 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers outside of the core study team.
Related trials for Alcohol; Harmful Use
Recruiting
Elastography-based Brief Alcohol Intervention in Hospitalized Individuals
Alcoholic Liver Disease (ALD), Alcohol Use Disorder
Active, not recruiting
Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
Alcohol Abuse, Harmful Alcohol Use
Recruiting
Sleep as a Mechanism of Change in Alcohol Use
Insomnia, Alcohol; Harmful Use
Not yet recruiting
Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
Chronic Pain, Unhealthy Alcohol Use
Not yet recruiting
Telephone-Based Acceptance and Commitment Therapy for Young Adult Hazardous Drinkers
Hazardous Drinking, Harmful Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Epstein, PhD principal investigator
UMass Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person sessions: ABCP_P and Video conference sessions: ABCP_T in people with Alcohol; Harmful Use, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Drinking Days (time frame: Change from baseline at 2 months post session 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.