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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA023502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| job activity contracting | Active Comparator | Standard services plus job activity contracting and alcohol monitoring |
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| reinforcement for negative alcohol samples | Experimental | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings |
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| reinforcement for completing activities | Experimental | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency management for alcohol abstinence | Behavioral | Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla J Rash, Ph.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Labor Agency | Middletown | Connecticut | 06457 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - Standard Job Activity Contracting and Alcohol Monitoring | Standard services plus job activity contracting and alcohol monitoring activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment |
| FG001 | Group B - Reinforcement for Negative Alcohol Samples | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment |
| FG002 | Group C - Reinforcement for Completing Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities |
| FG003 | Group D - Reinforcement for Negative Alcohol Samples & Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A - Standard Job Activity Contracting and Alcohol Monitoring | Standard services plus job activity contracting and alcohol monitoring activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment |
| BG001 | Group B - Reinforcement for Negative Alcohol Samples |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | N=234 analyzed. n=6 with no data: n=1 Group B withdrawal; n=5 had no samples submitted (n=1 Group A, n=1 Group B, n=1 group D) or none submitted on-time (n=2 Group B). | Posted | Median | Inter-Quartile Range | number of alcohol negative breath tests | 12 weeks |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A - Standard Job Activity Contracting and Alcohol Monitoring | Standard services plus job activity contracting and alcohol monitoring activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient substance use treatment | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheia Alessi | UConn Health | 860-679-1849 | salessi@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2021 | May 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2021 | May 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Contingency management for completing job related activities | Behavioral | Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period. |
|
| Job relelated activity contracting | Behavioral | Participants will complete job-related activity contracts each week with the goal of obtaining employment. |
|
Greatest number of consecutive days of submitting all breath tests requested on-time and reading alcohol negative |
| 12 weeks |
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment |
| BG002 | Group C - Reinforcement for Completing Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities |
| BG003 | Group D - Reinforcement for Negative Alcohol Samples & Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Group B - Reinforcement for Negative Alcohol Samples |
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment |
| OG002 | Group C - Reinforcement for Completing Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities |
| OG003 | Group D - Reinforcement for Negative Alcohol Samples & Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities |
|
|
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| Primary | 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) | N=234 analyzed. n=6 with no data: n=1 Group B withdrawal; n=5 had no samples submitted (n=1 Group A, n=1 Group B, n=1 group D) or none submitted on-time (n=2 Group B). | Posted | Mean | 95% Confidence Interval | percentage of alcohol negative tests | 12 weeks |
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| Primary | 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) | N=228, n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D | Posted | Median | Inter-Quartile Range | percentage of days work occurred | 12 weeks |
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| Primary | 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. | N=228 analyzed. n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D | Posted | Median | Inter-Quartile Range | days | 12 weeks |
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| Secondary | 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 | N=228 analyzed. n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D | Posted | Median | Inter-Quartile Range | percentage of days work occurred | 12 weeks |
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | days | 12 weeks |
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| 0 |
| 50 |
| 6 |
| 50 |
| 5 |
| 50 |
| EG001 | Group B - Reinforcement for Negative Alcohol Samples | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment | 0 | 65 | 8 | 65 | 5 | 65 |
| EG002 | Group C - Reinforcement for Completing Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities | 1 | 58 | 9 | 58 | 1 | 58 |
| EG003 | Group D - Reinforcement for Negative Alcohol Samples & Job Activities | Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities | 0 | 67 | 9 | 67 | 6 | 67 |
| Inpatient psychiatric treatment | Psychiatric disorders | Systematic Assessment |
|
| Inpatient medical treatment | General disorders | Systematic Assessment |
|
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