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CPT for Offenders With SUD (CPT)

29 augustus 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

376

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Therapeutic Education System (TES)
Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.
Gedragsmatig: 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).
Actieve vergelijker: 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.
Gedragsmatig: Standard Care
Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Coping Strategies Scale
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 6 months post-prison release
Measures for the cost effectiveness analyses.
6 months post-prison release
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Development and Research Institutes, Inc.

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2009

Primaire voltooiing (Werkelijk)

1 augustus 2011

Studie voltooiing (Werkelijk)

1 augustus 2012

Studieregistratiedata

Eerst ingediend

12 januari 2011

Eerst ingediend dat voldeed aan de QC-criteria

14 januari 2011

Eerst geplaatst (Schatting)

17 januari 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

2 september 2013

Laatste update ingediend die voldeed aan QC-criteria

29 augustus 2013

Laatst geverifieerd

1 augustus 2013

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NDRI-612
  • 1RC2DA028967 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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