- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01277939
CPT for Offenders With SUD (CPT)
Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Colorado
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Canon City, Colorado, Spojené státy, 81215
- Colorado Territorial Correctional Facility
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Canon City, Colorado, Spojené státy, 81215
- Four Mile Correctional Center
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Canon City, Colorado, Spojené státy, 81215
- Fremont Correctional Facility
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Denver, Colorado, Spojené státy, 80239
- Denver Women's Correctional Facility
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Model, Colorado, Spojené státy, 81509
- Trinidad Correctional Facility
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Pueblo, Colorado, Spojené státy, 81002
- La Vista Correctional Facility
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Sterling, Colorado, Spojené státy, 80751
- Sterling Correctional Facility
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Kentucky
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Lexington, Kentucky, Spojené státy, 40511
- Blackburn Correctional Complex
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Pennsylvania
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Cambridge Springs, Pennsylvania, Spojené státy, 16403
- SCI Cambridge Springs
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Washington
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Airway Heights, Washington, Spojené státy, 99001
- Airway Heights Corrections Center
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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).
|
|
Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Časové okno: 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
Časové okno: 6 months post-prison release
|
To detect any change in illicit drug use.
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6 months post-prison release
|
|
Risk Behavior Survey (Booth et al., 1993)
Časové okno: 6 months post-prison release
|
To assess both drug-related and sex-related HIV risk behavior.
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6 months post-prison release
|
|
DOC record systems
Časové okno: At an average of 11 months post-prison release
|
To provide the reincarceration status of each participant.
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At an average of 11 months post-prison release
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Coping Strategies Scale
Časové okno: 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
|
|
Addiction Severity Index-Lite
Časové okno: 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
|
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The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
Časové okno: 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)
Časové okno: 6 months post-prison release
|
Measures for the cost effectiveness analyses.
|
6 months post-prison release
|
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EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Stan Sacks, PhD, National Development & Research Institutes
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NDRI-612
- 1RC2DA028967 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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Klinické studie na Therapeutic Education System (TES)
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Children's Hospital Los AngelesNationwide Children's HospitalNábor