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临床试验/NCT01277939
NCT01277939已完成不适用

Computerized Psychosocial Treatment for Offenders With Substance Use Disorders

National Development and Research Institutes, Inc.20 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
376
试验地点
20
主要终点
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)

研究概览

简要总结

This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. The study will assess the comparative effectiveness of these interventions primarily by examining changes in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will also examine the extent to which these interventions improve psychosocial functioning (e.g., employment, health, and psychological status) and quality of life, and promote relevant skills acquisition (e.g., improve communication skills, reduce "criminal thinking"). The investigators predict significantly better outcomes for E vs. C due to TES' research-based content and use of proven informational technologies.

详细描述

The majority of individuals in criminal justice settings across the U.S. have a critical need for science-based, psychosocial treatment that targets substance use and HIV risk behavior. The investigative team has developed and demonstrated the efficacy of an interactive, computer-based, psychosocial treatment pro-gram, the Therapeutic Education System (TES), which can answer this need. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy), and employs state-of-the-art, proven informational technologies and multimedia learning tools to promote skills acquisition, experiential learning and behavioral change. This computer-based therapeutic tool allows complex interventions to be delivered with fidelity to the evidence-based model and at low cost due to its self-directed nature (e.g., minimal staff time/training needed), thus offering considerable potential for future sustainability and dissemination within criminal justice systems.

The study employs random assignment of incarcerated male and female offenders with substance use disorders (N=526) to either (1) TES (N=263), or (2) Standard Care (N=263), in a multi-site trial conducted in 8 prison substance abuse programs. Along with NDRI (the applicant organization), the collaborating study sites (University of California Los Angeles, Temple University, and the University of Kentucky) operate Research Centers that belong to the Criminal Justice Drug Abuse Treatment Studies (CJDATS) network, a NIDA-funded cooperative agreement, which has established relationships with criminal justice partners from Departments of Corrections across the U.S. Aim 1 is to test the comparative effectiveness of TES vs. Standard Care on measures of drug use (e.g., weeks of abstinence) and HIV risk behavior (both sex-related and drug-related HIV risk behavior) at 3- and 6-months post prison discharge, as well as on reincarceration rates using official Department of Corrections records. Aim 2 is to evaluate the cost and cost-effectiveness of TES relative to standard care. The investigators predict that TES will be significantly more effective and cost effective than Standard Care.

The project is significant in its use of an innovative, computer-based technology and in its potential to produce a major increase in the effective and cost-effective delivery of science-based psychosocial treatment to substance-abusing offenders in prison, and thereby make a considerable public health contribution. Thus, funding the proposed 2-year project can markedly accelerate the pace and achievement of research and dissemination efforts to meet the needs of the U.S. correctional community by providing effective and practical treatment interventions for its large substance-abusing population.

研究设计

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

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

  • individual's parole eligibility date or mandatory release date must be scheduled to occur within a minimum of 4 months (to allow intake an treatment to be completed) and a maximum of 6 months (to ensure that their release follows completion of their treatment such that sufficient time remains for post-prison follow-up interviews to occur within the two-year project timeframe)
  • the state criminal justice system must have identified the individual to have a substance use disorder that requires a substance abuse intervention
  • the individual must give their informed consent

排除标准

  • the individual must not already be participating in substance abuse treatment
  • the individual must speak English, as TES is now only available in English

结局指标

主要结局

Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)

时间窗: 6 months post-prison release

Measure for substance use.

Urinalysis

时间窗: 6 months post-prison release

To detect any change in illicit drug use.

Risk Behavior Survey (Booth et al., 1993)

时间窗: 6 months post-prison release

To assess both drug-related and sex-related HIV risk behavior.

DOC record systems

时间窗: At an average of 11 months post-prison release

To provide the reincarceration status of each participant.

次要结局

  • Coping Strategies Scale(6 months post-prison release)
  • Addiction Severity Index-Lite(6 months post-prison release)
  • The Treatment Services Review instrument (McLellan et al., www.tresearch.org)(6 months post-prison release)
  • Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)(6 months post-prison release)
  • EuroQol EQ5D (QOL) (the EuroQol Group, 1990)(6 months post-prison release)

研究者

发起方
National Development and Research Institutes, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (20)

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