CPT for Offenders With SUD

NCT01277939 | Completed DMC

• 2 other identifiers: NDRI-6121RC2DA028967
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 10

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.

Conditions

Computer-assisted, Evidence-based Psychosocial Intervention; for Substance Abuse Treatment

Outcome Measures

Primary Outcomes (4)

• Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)

  Measure for substance use.

  6 months post-prison release

• Urinalysis

  To detect any change in illicit drug use.

  6 months post-prison release

• Risk Behavior Survey (Booth et al., 1993)

  To assess both drug-related and sex-related HIV risk behavior.

  6 months post-prison release

• DOC record systems

  To provide the reincarceration status of each participant.

  At an average of 11 months post-prison release

Secondary Outcomes (5)

• Coping Strategies Scale

  6 months post-prison release

• Addiction Severity Index-Lite

  6 months post-prison release

• The Treatment Services Review instrument (McLellan et al., www.tresearch.org)

  6 months post-prison release

• Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)

  6 months post-prison release

• EuroQol EQ5D (QOL) (the EuroQol Group, 1990)

  6 months post-prison release

Study Arms (2)

Therapeutic Education System (TES)

EXPERIMENTAL

Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.

Behavioral: Therapeutic Education System (TES)

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Care

Interventions

Therapeutic Education System (TES) BEHAVIORAL

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).

Therapeutic Education System (TES)

Standard Care BEHAVIORAL

Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• the individual must not already be participating in substance abuse treatment
• the individual must speak English, as TES is now only available in English

Sponsors & Collaborators

• National Development and Research Institutes, Inc.: lead
• University of California, Los Angeles: collaborator
• Temple University: collaborator
• University of Kentucky: collaborator
• University of Miami: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (10)

Colorado Territorial Correctional Facility

Cañon City, Colorado, 81215, United States

Location

Four Mile Correctional Center

Cañon City, Colorado, 81215, United States

Location

Fremont Correctional Facility

Cañon City, Colorado, 81215, United States

Location

Denver Women's Correctional Facility

Denver, Colorado, 80239, United States

Location

Trinidad Correctional Facility

Model, Colorado, 81509, United States

Location

La Vista Correctional Facility

Pueblo, Colorado, 81002, United States

Location

Sterling Correctional Facility

Sterling, Colorado, 80751, United States

Location

Blackburn Correctional Complex

Lexington, Kentucky, 40511, United States

Location

SCI Cambridge Springs

Cambridge Springs, Pennsylvania, 16403, United States

Location

Airway Heights Corrections Center

Airway Heights, Washington, 99001, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stan Sacks, PhD

  National Development & Research Institutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 17, 2011
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

US (10)