跳至主要内容
临床试验/NCT02559609
NCT02559609已完成不适用

Interventions for Unemployed Hazardous Drinkers

UConn Health1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
Percent Alcohol Negative Breath Tests

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

reinforcement for negative alcohol samples

Experimental

Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings

干预措施: Contingency management for alcohol abstinence (Behavioral)

reinforcement for negative alcohol samples

Experimental

Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings

干预措施: Job relelated activity contracting (Behavioral)

job activity contracting

Active Comparator

Standard services plus job activity contracting and alcohol monitoring

干预措施: Job relelated activity contracting (Behavioral)

reinforcement for completing activities

Experimental

Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities

干预措施: Contingency management for completing job related activities (Behavioral)

reinforcement for completing activities

Experimental

Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities

干预措施: Job relelated activity contracting (Behavioral)

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

干预措施: Contingency management for alcohol abstinence (Behavioral)

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

干预措施: Contingency management for completing job related activities (Behavioral)

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

干预措施: Job relelated activity contracting (Behavioral)

结局指标

主要结局

Percent Alcohol Negative Breath Tests

时间窗: 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)

时间窗: 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)

Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)

时间窗: 12 weeks

Greatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL \< 0.02)

Time to First Worked

时间窗: 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.

次要结局

  • 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)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Rash

Assistant Professor

UConn Health

研究点 (1)

Loading locations...

相似试验