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CPT for Offenders With SUD (CPT)

29 de agosto de 2013 atualizado por: National Development and Research Institutes, Inc.

Computerized Psychosocial Treatment for Offenders With Substance Use Disorders

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.

Visão geral do estudo

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

Intervencional

Inscrição (Real)

376

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Colorado
      • Canon City, Colorado, Estados Unidos, 81215
        • Colorado Territorial Correctional Facility
      • Canon City, Colorado, Estados Unidos, 81215
        • Four Mile Correctional Center
      • Canon City, Colorado, Estados Unidos, 81215
        • Fremont Correctional Facility
      • Denver, Colorado, Estados Unidos, 80239
        • Denver Women's Correctional Facility
      • Model, Colorado, Estados Unidos, 81509
        • Trinidad Correctional Facility
      • Pueblo, Colorado, Estados Unidos, 81002
        • La Vista Correctional Facility
      • Sterling, Colorado, Estados Unidos, 80751
        • Sterling Correctional Facility
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40511
        • Blackburn Correctional Complex
    • Pennsylvania
      • Cambridge Springs, Pennsylvania, Estados Unidos, 16403
        • SCI Cambridge Springs
    • Washington
      • Airway Heights, Washington, Estados Unidos, 99001
        • Airway Heights Corrections Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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.
6 months post-prison release
Urinalysis
Prazo: 6 months post-prison release
To detect any change in illicit drug use.
6 months post-prison release
Risk Behavior Survey (Booth et al., 1993)
Prazo: 6 months post-prison release
To assess both drug-related and sex-related HIV risk behavior.
6 months post-prison release
DOC record systems
Prazo: At an average of 11 months post-prison release
To provide the reincarceration status of each participant.
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
6 months post-prison release
Addiction Severity Index-Lite
Prazo: 6 months post-prison release
Measures areas of health status improvement, psychological status, family/social relationships, and employment. (www.tresearch.org)
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
Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Prazo: 6 months post-prison release
Measures for the cost effectiveness analyses.
6 months post-prison release
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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Stan Sacks, PhD, National Development & Research Institutes

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2009

Conclusão Primária (Real)

1 de agosto de 2011

Conclusão do estudo (Real)

1 de agosto de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

12 de janeiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de janeiro de 2011

Primeira postagem (Estimativa)

17 de janeiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

2 de setembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de agosto de 2013

Última verificação

1 de agosto de 2013

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • NDRI-612
  • 1RC2DA028967 (Concessão/Contrato do NIH dos EUA)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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