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临床试验/NCT03501732
NCT03501732Unknown不适用

Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback

George Mason University0 个研究点目标入组 150 人开始时间: 2019年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
主要终点
Changes in substance use

研究概览

简要总结

A key component of effective offender treatment is an initial assessment of risk factors followed by feedback to facilitate problem awareness and engagement in appropriate treatment and/or behavior change. Feedback regarding areas of high risk, however, can be experienced as threatening.

The investigators propose to develop, fine-tune, and pilot-test a computerized system for risk assessment and feedback, including evaluation of a brief pre-feedback prosocial values affirmation exercise (Cohen & Sherman, 2014) aimed at decreasing defensiveness and increasing inmates' willingness to access and process risk-relevant information and to utilize post-release treatment resources, thereby reducing post-release substance misuse, HIV risk behavior, and criminal recidivism. Participants will be 170 jail inmates nearing release into the community - 20 pilot participants and 150 study participants randomly assigned to one of three conditions: (1) Values Affirmation + Personalized Risk Feedback; (2) Personalized Risk Feedback only; (3) Control. The baseline and risk assessment, values affirmation manipulation, and personalized risk feedback will be presented via touch-screen computers, requiring minimal training to administer. Analyses will assess:

  1. The feasibility of utilizing a computerized system to assess and share risk information with jail inmates, including a brief values affirmation exercise to reduce defensiveness;
  2. The acceptability of this approach from the perspectives of jail staff and inmates themselves;
  3. The impact of the intervention on observed proximal outcomes (mechanisms of action), such as time spent viewing feedback, electing to print a copy of informational and treatment resources, and consequent changes in perceptions of risk, treatability, etc.;
  4. The impact of the intervention on key post-release outcomes including engagement in relevant treatment services, substance misuse, HIV risk behaviors, re-offense and re-arrest;
  5. The links between proximal outcomes (MOAs) and key post-release outcomes;
  6. Potential moderators of treatment effectiveness.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Sufficient proficiency in spoken English to understand computer-assisted assessments and feedback
  • post-sentencing with a sentence (i.e., less than 12 months) likely to be served out at the jail (vs. a state or federal prison) and likely to be released into the community. The invitation to participate will be timed so treatment is delivered toward the end of incarceration (within one week of release) to minimize decay of effects, and to capitalize on the motivational value of the up-coming release.

排除标准

  • Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)

研究组 & 干预措施

Values Affirmation plus Risk Feedback

Experimental

Values Affirmation with Risk Feedback in substance use and HIV domains of risk

干预措施: Values Affirmation (Behavioral)

Values Affirmation plus Risk Feedback

Experimental

Values Affirmation with Risk Feedback in substance use and HIV domains of risk

干预措施: Risk Feedback (Behavioral)

Risk Feedback

Active Comparator

Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk

干预措施: Risk Feedback (Behavioral)

Sleep Control

No Intervention

Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback

结局指标

主要结局

Changes in substance use

时间窗: 3 months post-release (Time 2)

Changes in substance use -- among those who were identified at risk and who thus received feedback, pre-post incarceration changes in terms of pre-incarceration standard deviations. If more than one domain of feedback, average standard deviation change.

Changes in HIV risk behavior

时间窗: 3 months post-release (Time 2)

Changes in HIV risk behavior -- among those who were identified at risk and who thus received feedback, pre-post incarceration changes in terms of pre-incarceration standard deviations. If more than one domain of feedback (risky sex, risky needle use), average standard deviation change.

次要结局

  • Requests Community Resources(Immediately following intervention (Time 1))
  • Changes in accuracy of perceptions of normative risk behavior(Immediately following intervention (Time 1))
  • Makes Use of Community Resources(3 months post-release (Time 2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

June Tangney

Professor

George Mason University

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