CPT for Offenders With SUD (CPT)
Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Colorado
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Canon City、Colorado、アメリカ、81215
- Colorado Territorial Correctional Facility
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Canon City、Colorado、アメリカ、81215
- Four Mile Correctional Center
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Canon City、Colorado、アメリカ、81215
- Fremont Correctional Facility
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Denver、Colorado、アメリカ、80239
- Denver Women's Correctional Facility
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Model、Colorado、アメリカ、81509
- Trinidad Correctional Facility
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Pueblo、Colorado、アメリカ、81002
- La Vista Correctional Facility
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Sterling、Colorado、アメリカ、80751
- Sterling Correctional Facility
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Kentucky
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Lexington、Kentucky、アメリカ、40511
- Blackburn Correctional Complex
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Pennsylvania
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Cambridge Springs、Pennsylvania、アメリカ、16403
- SCI Cambridge Springs
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Washington
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Airway Heights、Washington、アメリカ、99001
- Airway Heights Corrections Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- the individual must not already be participating in substance abuse treatment
- the individual must speak English, as TES is now only available in English
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Therapeutic Education System (TES)
Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.
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Therapeutic Education System (TES) is an interactive, computer-based, psychosocial treatment program.
TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy).
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アクティブコンパレータ:Standard Care
The Control (C) condition, Standard Care, consisting of psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.
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Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
時間枠:6 months post-prison release
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Measure for substance use.
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6 months post-prison release
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Urinalysis
時間枠:6 months post-prison release
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To detect any change in illicit drug use.
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6 months post-prison release
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Risk Behavior Survey (Booth et al., 1993)
時間枠:6 months post-prison release
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To assess both drug-related and sex-related HIV risk behavior.
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6 months post-prison release
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DOC record systems
時間枠:At an average of 11 months post-prison release
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To provide the reincarceration status of each participant.
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At an average of 11 months post-prison release
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Coping Strategies Scale
時間枠:6 months post-prison release
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Measures skills acquisition, such as problem solving and dealing with urges to use substances of abuse (Litt et al., 2005), and psychosocial functioning
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6 months post-prison release
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Addiction Severity Index-Lite
時間枠:6 months post-prison release
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Measures areas of health status improvement, psychological status, family/social relationships, and employment.
(www.tresearch.org)
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6 months post-prison release
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The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
時間枠:6 months post-prison release
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Used to investigate the role of treatment services received post-release (in aftercare).
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6 months post-prison release
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Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
時間枠:6 months post-prison release
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Measures for the cost effectiveness analyses.
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6 months post-prison release
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EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
時間枠:6 months post-prison release
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Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).
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6 months post-prison release
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協力者と研究者
協力者
捜査官
- 主任研究者:Stan Sacks, PhD、National Development & Research Institutes
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Therapeutic Education System (TES)の臨床試験
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University of FloridaBrooks Rehabilitation; BrainQ Technologies Ltd.募集
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Okuvision GmbHUniversitätsklinikum Hamburg-Eppendorf; Nubilaria Srl; CONVIDIA clinical research GmbH; TentaConsult... と他の協力者募集
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Avacen, Inc.University of California, San Diego; San Diego Veterans Healthcare System完了