- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01277939
CPT for Offenders With SUD (CPT)
Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Colorado
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Canon City, Colorado, Vereinigte Staaten, 81215
- Colorado Territorial Correctional Facility
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Canon City, Colorado, Vereinigte Staaten, 81215
- Four Mile Correctional Center
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Canon City, Colorado, Vereinigte Staaten, 81215
- Fremont Correctional Facility
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Denver, Colorado, Vereinigte Staaten, 80239
- Denver Women's Correctional Facility
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Model, Colorado, Vereinigte Staaten, 81509
- Trinidad Correctional Facility
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Pueblo, Colorado, Vereinigte Staaten, 81002
- La Vista Correctional Facility
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Sterling, Colorado, Vereinigte Staaten, 80751
- Sterling Correctional Facility
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40511
- Blackburn Correctional Complex
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Pennsylvania
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Cambridge Springs, Pennsylvania, Vereinigte Staaten, 16403
- SCI Cambridge Springs
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Washington
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Airway Heights, Washington, Vereinigte Staaten, 99001
- Airway Heights Corrections Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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).
|
Aktiver 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.
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Coping Strategies Scale
Zeitfenster: 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
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6 months post-prison release
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Addiction Severity Index-Lite
Zeitfenster: 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)
Zeitfenster: 6 months post-prison release
|
Used to investigate the role of treatment services received post-release (in aftercare).
|
6 months post-prison release
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Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Zeitfenster: 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)
Zeitfenster: 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).
|
6 months post-prison release
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Stan Sacks, PhD, National Development & Research Institutes
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NDRI-612
- 1RC2DA028967 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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-
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