Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

CPT for Offenders With SUD (CPT)

29. august 2013 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

376

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Development and Research Institutes, Inc.

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2009

Primær fullføring (Faktiske)

1. august 2011

Studiet fullført (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

12. januar 2011

Først innsendt som oppfylte QC-kriteriene

14. januar 2011

Først lagt ut (Anslag)

17. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere