NCT02559609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

April 19, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 22, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

6.1 years

First QC Date

August 24, 2015

Results QC Date

May 31, 2023

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

    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)

    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 Outcomes (2)

  • Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)

    12 weeks

  • Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)

    12 weeks

Study Arms (4)

job activity contracting

ACTIVE COMPARATOR

Standard services plus job activity contracting and alcohol monitoring

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

Behavioral: Contingency management for alcohol abstinenceBehavioral: 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

Behavioral: Contingency management for completing job related activitiesBehavioral: 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

Behavioral: Contingency management for alcohol abstinenceBehavioral: Contingency management for completing job related activitiesBehavioral: Job relelated activity contracting

Interventions

Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.

reinforcement for negative alcohol samplesreinforcement for negative alcohol samples & activities

Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.

reinforcement for completing activitiesreinforcement for negative alcohol samples & activities

Participants will complete job-related activity contracts each week with the goal of obtaining employment.

job activity contractingreinforcement for completing activitiesreinforcement for negative alcohol samplesreinforcement for negative alcohol samples & activities

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Labor Agency

Middletown, Connecticut, 06457, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Sheia Alessi
Organization
UConn Health

Study Officials

  • Carla J Rash, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 24, 2015

Study Start

April 19, 2016

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

April 23, 2024

Results First Posted

June 22, 2023

Record last verified: 2024-04

Locations