UnemploymentNCT02559609
Interventions for Unemployed Hazardous Drinkers
A study testing Contingency management for alcohol abstinence, Contingency management for completing job related activities and Job relelated activity contracting in people with Unemployment and Hazardous Drinking, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unemployment, Hazardous Drinking
- What is being tested?
- Contingency management for alcohol abstinence, Contingency management for completing job related activities and Job relelated activity contracting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2016to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Unemployment, Hazardous Drinking
- Being tested
- Contingency management for alcohol abstinence, Contingency management for completing job related activities, Job relelated activity contracting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency management for alcohol abstinenceBehavioural
Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.
Contingency management for completing job related activitiesBehavioural
Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.
Job relelated activity contractingBehavioural
Participants will complete job-related activity contracts each week with the goal of obtaining employment.
| Study group | Role | What they receive |
|---|---|---|
| job activity contracting | Active comparator | Standard services plus job activity contracting and alcohol monitoring Receives: Behavioral: Job relelated activity contracting |
| reinforcement for negative alcohol samples | Experimental | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings Receives: Behavioral: Contingency management for alcohol abstinence; Behavioral: Job relelated activity contracting |
| reinforcement for completing activities | Experimental | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities Receives: Behavioral: Contingency management for completing job related activities; Behavioral: Job relelated activity contracting |
| reinforcement for negative alcohol samples & activities | Experimental | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities Receives: Behavioral: Contingency management for alcohol abstinence; Behavioral: Contingency management for completing job related activities; Behavioral: Job relelated activity contracting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)
Greatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL < 0.02)
Measured: 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 (BAL < .02)
Measured: 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)
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start19 Apr 2016
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UnemploymentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Carla Rash, UConn Health
- Investigators
- Carla J Rash, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559609
- Sponsor's protocol ID
- 15-041-2
- Other IDs
- R01AA023502
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2015
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Unemployed Hazardous Drinkers
- ClinicalTrials.gov ID
- NCT02559609
- Acronym / sponsor ID
- 15-041-2
- Conditions
- Unemployment, Hazardous Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| job activity contracting | Active comparator | Behavioral: Job relelated activity contractingStandard services plus job activity contracting and alcohol monitoring |
| reinforcement for negative alcohol samples | Experimental | Behavioral: Contingency management for alcohol abstinence, Behavioral: Job relelated activity contractingStandard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings |
| reinforcement for completing activities | Experimental | Behavioral: Contingency management for completing job related activities, Behavioral: Job relelated activity contractingStandard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities |
| reinforcement for negative alcohol samples & activities | Experimental | Behavioral: Contingency management for alcohol abstinence, Behavioral: Contingency management for completing job related activities, Behavioral: Job relelated activity contractingStandard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Contingency management for alcohol abstinenceParticipants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period. | Behavioural | reinforcement for negative alcohol samples, reinforcement for negative alcohol samples & activities |
| Contingency management for completing job related activitiesParticipants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period. | Behavioural | reinforcement for completing activities, reinforcement for negative alcohol samples & activities |
| Job relelated activity contractingParticipants will complete job-related activity contracts each week with the goal of obtaining employment. | Behavioural | job activity contracting, reinforcement for completing activities, reinforcement for negative alcohol samples, reinforcement for negative alcohol samples & activities |
Primary outcome
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)
Time frame: 12 weeks
Greatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL < 0.02)
Percent Alcohol Negative Breath Tests
Time frame: 12 weeks
Of alcohol breath tests requested, the percentage submitted on-time (within 1-hour of prompt) and reading alcohol-negative (BAL < .02)
Percent of Days Worked for Pay (Missing Data Treated as Missing)
Time frame: 12 weeks
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)
Time to First Worked
Time frame: 12 weeks
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.
2 secondary outcomes
Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)
Time frame: 12 weeks
Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carla J Rash, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management for alcohol abstinence, Contingency management for completing job related activities and Job relelated activity contracting in people with Unemployment and Hazardous Drinking, run by UConn Health 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 7 inclusion and 6 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 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure) (time frame: 12 weeks). 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 Apr 2024.