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CPT for Offenders With SUD (CPT)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Education System (TES)
Standard Care
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Computer-assisted, Evidence-based Psychosocial Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Colorado Territorial Correctional Facility
  • Four Mile Correctional Center
  • Fremont Correctional Facility
  • Denver Women's Correctional Facility
  • Trinidad Correctional Facility
  • La Vista Correctional Facility
  • Sterling Correctional Facility
  • Blackburn Correctional Complex
  • SCI Cambridge Springs
  • Airway Heights Corrections Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic Education System (TES)

Standard Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Measure for substance use.
Urinalysis
To detect any change in illicit drug use.
Risk Behavior Survey (Booth et al., 1993)
To assess both drug-related and sex-related HIV risk behavior.
DOC record systems
To provide the reincarceration status of each participant.

Secondary Outcome Measures

Coping Strategies Scale
Measures skills acquisition, such as problem solving and dealing with urges to use substances of abuse (Litt et al., 2005), and psychosocial functioning
Addiction Severity Index-Lite
Measures areas of health status improvement, psychological status, family/social relationships, and employment. (www.tresearch.org)
The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
Used to investigate the role of treatment services received post-release (in aftercare).
Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Measures for the cost effectiveness analyses.
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).

Full Information

First Posted
January 12, 2011
Last Updated
August 29, 2013
Sponsor
National Development and Research Institutes, Inc.
Collaborators
University of California, Los Angeles, Temple University, University of Kentucky, University of Miami, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01277939
Brief Title
CPT for Offenders With SUD
Acronym
CPT
Official Title
Computerized Psychosocial Treatment for Offenders With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
University of California, Los Angeles, Temple University, University of Kentucky, University of Miami, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Computer-assisted, Evidence-based Psychosocial Intervention, for Substance Abuse Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Education System (TES)
Arm Type
Experimental
Arm Description
Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Education System (TES)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.
Primary Outcome Measure Information:
Title
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)
Description
Measure for substance use.
Time Frame
6 months post-prison release
Title
Urinalysis
Description
To detect any change in illicit drug use.
Time Frame
6 months post-prison release
Title
Risk Behavior Survey (Booth et al., 1993)
Description
To assess both drug-related and sex-related HIV risk behavior.
Time Frame
6 months post-prison release
Title
DOC record systems
Description
To provide the reincarceration status of each participant.
Time Frame
At an average of 11 months post-prison release
Secondary Outcome Measure Information:
Title
Coping Strategies Scale
Description
Measures skills acquisition, such as problem solving and dealing with urges to use substances of abuse (Litt et al., 2005), and psychosocial functioning
Time Frame
6 months post-prison release
Title
Addiction Severity Index-Lite
Description
Measures areas of health status improvement, psychological status, family/social relationships, and employment. (www.tresearch.org)
Time Frame
6 months post-prison release
Title
The Treatment Services Review instrument (McLellan et al., www.tresearch.org)
Description
Used to investigate the role of treatment services received post-release (in aftercare).
Time Frame
6 months post-prison release
Title
Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)
Description
Measures for the cost effectiveness analyses.
Time Frame
6 months post-prison release
Title
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)
Description
Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).
Time Frame
6 months post-prison release

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Sacks, PhD
Organizational Affiliation
National Development & Research Institutes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Territorial Correctional Facility
City
Canon City
State/Province
Colorado
ZIP/Postal Code
81215
Country
United States
Facility Name
Four Mile Correctional Center
City
Canon City
State/Province
Colorado
ZIP/Postal Code
81215
Country
United States
Facility Name
Fremont Correctional Facility
City
Canon City
State/Province
Colorado
ZIP/Postal Code
81215
Country
United States
Facility Name
Denver Women's Correctional Facility
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Trinidad Correctional Facility
City
Model
State/Province
Colorado
ZIP/Postal Code
81509
Country
United States
Facility Name
La Vista Correctional Facility
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81002
Country
United States
Facility Name
Sterling Correctional Facility
City
Sterling
State/Province
Colorado
ZIP/Postal Code
80751
Country
United States
Facility Name
Blackburn Correctional Complex
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40511
Country
United States
Facility Name
SCI Cambridge Springs
City
Cambridge Springs
State/Province
Pennsylvania
ZIP/Postal Code
16403
Country
United States
Facility Name
Airway Heights Corrections Center
City
Airway Heights
State/Province
Washington
ZIP/Postal Code
99001
Country
United States

12. IPD Sharing Statement

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CPT for Offenders With SUD

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