Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

CPT for Offenders With SUD (CPT)

29 de agosto de 2013 actualizado 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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

376

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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 activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Periodo de tiempo: 6 months post-prison release
Measure for substance use.
6 months post-prison release
Urinalysis
Periodo de tiempo: 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)
Periodo de tiempo: 6 months post-prison release
To assess both drug-related and sex-related HIV risk behavior.
6 months post-prison release
DOC record systems
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Coping Strategies Scale
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 6 months post-prison release
Measures for the cost effectiveness analyses.
6 months post-prison release
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2009

Finalización primaria (Actual)

1 de agosto de 2011

Finalización del estudio (Actual)

1 de agosto de 2012

Fechas de registro del estudio

Enviado por primera vez

12 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

14 de enero de 2011

Publicado por primera vez (Estimar)

17 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de septiembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

29 de agosto de 2013

Última verificación

1 de agosto de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • NDRI-612
  • 1RC2DA028967 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Therapeutic Education System (TES)

Suscribir