Clinical trial NCT01277939: CPT for Offenders With SUD
Official title: Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computer-assisted, Evidence-based Psychosocial Intervention
for Substance Abuse Treatment
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Temple University
name: University of Kentucky
name: University of Miami
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-17
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
timeFrame: 6 months post-prison release
measure: Urinalysis
timeFrame: 6 months post-prison release
measure: Risk Behavior Survey (Booth et al., 1993)
timeFrame: 6 months post-prison release
measure: DOC record systems
timeFrame: At an average of 11 months post-prison release
Secondary outcomes:
measure: Coping Strategies Scale
timeFrame: 6 months post-prison release
measure: Addiction Severity Index-Lite
timeFrame: 6 months post-prison release
measure: The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
timeFrame: 6 months post-prison release
measure: Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
timeFrame: 6 months post-prison release
measure: EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
timeFrame: 6 months post-prison release
Other outcomes:
Locations:
city: Canon City
country: United States
facility: Colorado Territorial Correctional Facility
state: Colorado
city: Canon City
country: United States
facility: Four Mile Correctional Center
state: Colorado
city: Canon City
country: United States
facility: Fremont Correctional Facility
state: Colorado
city: Denver
country: United States
facility: Denver Women's Correctional Facility
state: Colorado
city: Model
country: United States
facility: Trinidad Correctional Facility
state: Colorado
city: Pueblo
country: United States
facility: La Vista Correctional Facility
state: Colorado
city: Sterling
country: United States
facility: Sterling Correctional Facility
state: Colorado
city: Lexington
country: United States
facility: Blackburn Correctional Complex
state: Kentucky
city: Cambridge Springs
country: United States
facility: SCI Cambridge Springs
state: Pennsylvania
city: Airway Heights
country: United States
facility: Airway Heights Corrections Center
state: Washington
Study officials:
affiliation: National Development & Research Institutes
name: Stan Sacks, PhD
role: PRINCIPAL_INVESTIGATOR
References: