Interventions for Unemployed Hazardous Drinkers

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Interventions for Unemployed Hazardous Drinkers

Conditions
-----------------
Unemployment, Hazardous Drinking

Intervention / Treatment
-----------------
* Behavioral: Contingency management for alcohol abstinence
* Behavioral: Contingency management for completing job related activities
* Behavioral: Job relelated activity contracting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: job activity contracting<br>Standard services plus job activity contracting and alcohol monitoring | Behavioral: Job relelated activity contracting<br>* Participants will complete job-related activity contracts each week with the goal of obtaining employment.<br>|
| Experimental: reinforcement for negative alcohol samples<br>Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings | Behavioral: Contingency management for alcohol abstinence<br>* Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.<br>Behavioral: Job relelated activity contracting<br>* Participants will complete job-related activity contracts each week with the goal of obtaining employment.<br>|
| Experimental: reinforcement for completing activities<br>Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities | Behavioral: Contingency management for completing job related activities<br>* Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.<br>Behavioral: Job relelated activity contracting<br>* Participants will complete job-related activity contracts each week with the goal of obtaining employment.<br>|
| Experimental: reinforcement for negative alcohol samples & activities<br>Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities | Behavioral: Contingency management for alcohol abstinence<br>* Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.<br>Behavioral: Contingency management for completing job related activities<br>* Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure) | Greatest number of consecutive breath tests submitted on-time and reading alcohol negative | 12 weeks | 
| Percent Alcohol Negative Breath Tests | Of alcohol breath tests requested, the percentage submitted on-time (within 1-hour of prompt) and reading alcohol-negative | 12 weeks | 
| Percent of Days Worked for Pay (Missing Data Treated as Missing) | 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) | 12 weeks | 
| Time to First Worked | 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) | 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) | Greatest number of consecutive days of submitting all breath tests requested on-time and reading alcohol negative | 12 weeks |