- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01277939
CPT for Offenders With SUD (CPT)
Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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 |
|---|---|
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Experimental: 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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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Coping Strategies Scale
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stan Sacks, PhD, National Development & Research Institutes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre Therapeutic Education System (TES)
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