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- Ensaio Clínico NCT01277939
CPT for Offenders With SUD (CPT)
Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Colorado
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Canon City, Colorado, Estados Unidos, 81215
- Colorado Territorial Correctional Facility
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Canon City, Colorado, Estados Unidos, 81215
- Four Mile Correctional Center
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Canon City, Colorado, Estados Unidos, 81215
- Fremont Correctional Facility
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Denver, Colorado, Estados Unidos, 80239
- Denver Women's Correctional Facility
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Model, Colorado, Estados Unidos, 81509
- Trinidad Correctional Facility
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Pueblo, Colorado, Estados Unidos, 81002
- La Vista Correctional Facility
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Sterling, Colorado, Estados Unidos, 80751
- Sterling Correctional Facility
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40511
- Blackburn Correctional Complex
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Pennsylvania
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Cambridge Springs, Pennsylvania, Estados Unidos, 16403
- SCI Cambridge Springs
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Washington
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Airway Heights, Washington, Estados Unidos, 99001
- Airway Heights Corrections Center
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Therapeutic Education System (TES)
Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.
|
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).
|
|
Comparador Ativo: 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.
|
Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Prazo: 6 months post-prison release
|
Measure for substance use.
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6 months post-prison release
|
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Urinalysis
Prazo: 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)
Prazo: 6 months post-prison release
|
To assess both drug-related and sex-related HIV risk behavior.
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6 months post-prison release
|
|
DOC record systems
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Coping Strategies Scale
Prazo: 6 months post-prison release
|
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
Prazo: 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
|
|
The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
Prazo: 6 months post-prison release
|
Used to investigate the role of treatment services received post-release (in aftercare).
|
6 months post-prison release
|
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Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Prazo: 6 months post-prison release
|
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)
Prazo: 6 months post-prison release
|
Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).
|
6 months post-prison release
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stan Sacks, PhD, National Development & Research Institutes
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NDRI-612
- 1RC2DA028967 (Concessão/Contrato do NIH dos EUA)
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