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CPT for Offenders With SUD (CPT)

29 augusti 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

376

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Therapeutic Education System (TES)
Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.
Beteende: Therapeutic Education System (TES)
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).
Aktiv komparator: 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.
Beteende: Standard Care
Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Coping Strategies Scale
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 6 months post-prison release
Measures for the cost effectiveness analyses.
6 months post-prison release
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Development and Research Institutes, Inc.

Samarbetspartners

National Institute on Drug Abuse (NIDA)
University of California, Los Angeles
University of Miami
Temple University
University of Kentucky

Utredare

  • Huvudutredare: Stan Sacks, PhD, National Development & Research Institutes

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2009

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 augusti 2012

Studieregistreringsdatum

Först inskickad

12 januari 2011

Först inskickad som uppfyllde QC-kriterierna

14 januari 2011

Första postat (Uppskatta)

17 januari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

2 september 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 augusti 2013

Senast verifierad

1 augusti 2013

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NDRI-612
  • 1RC2DA028967 (U.S.S. NIH-anslag/kontrakt)

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