- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02559609
Interventions for Unemployed Hazardous Drinkers
May 31, 2023 updated by: Carla Rash, UConn Health
Despite recent improvements in the US economy, unemployment remains a significant concern, and estimates indicate that one-third of unemployed persons drink at hazardous levels, adversely impacting their health and abilities to find jobs.
Reinforcement interventions are highly efficacious in reducing substance use, and they can be applied to increase job-seeking activities as well.
In partnership with CT United Labor Agency, this project is designed to reduce hazardous drinking and enhance active participation in job-seeking activities among those with job loss.
It will evaluate the independent and combined effects of reinforcing negative breathalyzer samples and job-seeking activities to ascertain the simplest and most cost-effective approach to improving outcomes in this population.
Unemployed individuals with hazardous drinking (N = 280) will be randomly assigned to one of four conditions using a 2 x 2 design: standard care, standard care with reinforcement for submitting negative breathalyzer samples, standard care with reinforcement for job-seeking activities, or standard care plus reinforcement for both negative breathalyzer samples and job-seeking activities.
Participants in all conditions will receive usual services part of CT United Labor Agency, along with a novel remote breath alcohol monitoring procedure.
The study interventions will be in effect for three months, and participants will be followed for one year.
Alcohol and other drug use, employment, psychiatric symptoms, and global measures of health will be assessed throughout treatment and follow-up.
Reinforcing negative breathalyzer samples is expected to significantly reduce drinking, and reinforcing job-seeking activities is expected to increase re-employment rates and reduce time until job attainment.
Reinforcing both negative breathalyzer samples and job-seeking activities is hypothesized to improve outcomes along both domains.
The reinforcement interventions may also decrease psychiatric distress and slow progression of physical decline, common among the unemployed.
If efficacious and cost-effective, results from this study may stimulate adoption of reinforcement interventions in the context of unemployment services.
Reducing the adverse consequences of hazardous drinking and improving job re-entry may have pronounced benefits in a highly vulnerable segment of the US population.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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Middletown, Connecticut, United States, 06457
- United Labor Agency
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 18-65 years
- not worked for pay in the formal economy for >4 weeks
- willing to participate in a workforce training program and willing to accept either part-time or full-time work
- hazardous alcohol use defined by AUDIT scores >8, a mean of >2 drinks/drinking day or >14 drinks/week in men (>1 drink/drinking day or >7 drinks/week in women) in the past 2 months, or submission of an alcohol positive breathalyzer (>0.02 g/dl) or EtG positive urine sample
- English or Spanish speaking and able to read at 5th grade level
- have a valid photo ID
- willing and able to use study equipment and sign an off-campus property transfer form
Exclusion Criteria:
- have begun receiving unemployment benefits within the past 4 weeks
- worked full- or part-time <3 months in the past 3 years in the formal or informal economy
- physiological alcohol withdrawal symptoms (score >10 on Clinical Institute Withdrawal Assessment for Alcohol-revised)
- physiological withdrawal symptoms from an illicit drug use disorder
- serious untreated psychiatric illness
- in recovery from gambling disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: job activity contracting
Standard services plus job activity contracting and alcohol monitoring
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Participants will complete job-related activity contracts each week with the goal of obtaining employment.
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Experimental: reinforcement for negative alcohol samples
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
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Participants will complete job-related activity contracts each week with the goal of obtaining employment.
Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.
|
Experimental: reinforcement for completing activities
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
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Participants will complete job-related activity contracts each week with the goal of obtaining employment.
Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.
|
Experimental: reinforcement for negative alcohol samples & activities
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
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Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.
Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)
Time Frame: 12 weeks
|
Greatest number of consecutive breath tests submitted on-time and reading alcohol negative
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12 weeks
|
Percent Alcohol Negative Breath Tests
Time Frame: 12 weeks
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Of alcohol breath tests requested, the percentage submitted on-time (within 1-hour of prompt) and reading alcohol-negative
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12 weeks
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Percent of Days Worked for Pay (Missing Data Treated as Missing)
Time Frame: 12 weeks
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The percentage of days of work for pay (in the formal or informal economy), with the number of days of data in the denominator (missing data considered missing)
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12 weeks
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Time to First Worked
Time Frame: 12 weeks
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From study day 1, the number of days until first worked in the formal or informal economy during the 12-week intervention, censored at day 85.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)
Time Frame: 12 weeks
|
The percent of days worked for pay (in the formal or informal economy), with 84 days (intervention period duration; missing treated as not working) in the denominator
|
12 weeks
|
Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)
Time Frame: 12 weeks
|
Greatest number of consecutive days of submitting all breath tests requested on-time and reading alcohol negative
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carla J Rash, Ph.D., UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2016
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
August 24, 2015
First Submitted That Met QC Criteria
September 23, 2015
First Posted (Estimated)
September 24, 2015
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
May 31, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 15-041-2
- R01AA023502 (U.S. NIH Grant/Contract)
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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