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Colorado Women's TC Project

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Recovery by Choice
The Intensive Outpatient Program (IOP)
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 Substance-Related Disorders

Eligibility Criteria

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

Inclusion criteria: at least 6 months, and no more than 24 months, remaining until parole eligibility; a CDOC "Standardized Offender Assessment" (SOA; CDOC, 2004) score indicative of serious substance abuse problems mandating substance abuse treatment; and a security risk level classification of minimum, minimum-restricted, or medium (necessary to permit participation in treatment). Exclusion criteria: less than 6 months, or more than 24 months, remaining until parole eligibility; a CDOC "Standardized Offender Assessment" (SOA; CDOC, 2004) score that is not indicative of serious substance abuse problems mandating substance abuse treatment; or a security risk level classification above medium.

Sites / Locations

  • Denver Women's Correctional Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recovery by Choice

Intensive Outpatient Program

Arm Description

A modified Therapeutic Community program.

Designed to address substance abuse and criminality, with a focus on prevention of relapse and recidivism.

Outcomes

Primary Outcome Measures

Intake CTCR Baseline & Follow-Up Protocol (CTCR Protocol)
The CTCR Protocol (CTCR, 1992) is a structured interview that was adapted from the ASI and DATAR for use in community treatment and the criminal justice system; additional versions, including Green's Trauma Scale (Green, 1996) to measure trauma and abuse, have been developed for baseline, during treatment and community follow-up with women. It assesses the following domains: socio-demographic background, substance use, psychosocial functioning, criminal justice involvement, education, employment, parenting, peer and family support, and health.
Beck Depression Inventory-II (BDI-II)
The BDI-II (Beck, Steer, & Brown, 1996). The BDI measures three domains of depression: Somatic Depression, Cognitive Depression and Total Depression Scores, consistent with the DSM-IV criteria for depressive disorders.
Rosenberg Self-Esteem (SES)
The SES (Rosenberg, 1965) is the most widely used global measure of self-esteem,
Symptom CheckList 90-R (SCL90-R)
The SCL90-R (Derogatis, 1983) measures 9 domains including: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, providing a global index of distress: Global Severity Index (GSI).
Diagnostic Interview Survey (DIS-IV)
The DIS-IV (Robins et al., 1995) is a structured clinical interview to generate DSM-IV lifetime and current psychiatric and substance use/abuse diagnoses.
Parenting Practices Scale (PPS)
The PPS measures the parenting practices among parents of children under age 12.
Social Support Arizona Social Support Scale (ASSIS)
The ASSIS (Barrera, 1980; Barrera, Sandier, & Ramsay, 1981; Stevens, Murphy, & McGrath, 2000) measures social support networks with a series of questions regarding the people who are important to the client and the number of ways they support the individual. Areas covered by the scale include: intimate interaction, material aid, advice, positive feedback, physical assistance, social participation, negative interactions, and personal characteristic of network members.
Texas Christian University Resident Evaluation of Self and Treatment (TCU-REST)
The TCU-REST (Knight, Simpson & Chatham, 1997; Simpson & Knight, 1998) provides measures of client process and progress in treatment in the following domains: psychological functioning (including scales for self-esteem, depression, anxiety, self-efficacy, and decision-making confidence.
Client Assessment Inventory (CAI)
The CAI (Kressel, 1998) measures client perceptions of progress and participation in TC treatment, in 14 domains: maturity, responsibility, values, drug/criminal life style, maintaining images, work attitude, social skills, cognitive skills, emotional skills, sense of well being, accepting program structure and philosophy, participating in group activities, attachment to, and investment in, the program. The latter two scales provide measures of participation and commitment.
Circumstances, Motivation and Readiness (CMR)
The CMR assesses motivation and readiness for treatment (Circumstances 1 (external influences to enter or remain in treatment), Circumstances 2, (external influences to leave treatment), and Motivation (internal recognition of the need to change).
Cost: Drug Abuse Treatment Cost Analysis Program (DATCAP)
Service Utilization Form (SUF)
Partner Abuse Scales (PAS)
The PAS (Hudson, 1990) consists of two matched pairs of scales, each consisting of 25 Likert type items. The Partner Abuse: Physical (RASPH) and the Partner Abuse: Non-Physical (PASNP) measure self-reports of physical and non-physical abuse between partners.

Secondary Outcome Measures

Colorado Department of Corrections Record Information System (CDOC-RIS)
The CDOC-RIS will be accessed to gather data on the following measures: current charge on which incarceration is based; other previous charges; current sentence; status of violent offenses; urine toxicological information on drug and alcohol use; medical information; dates of prior incarcerations; disciplinary reports; all services received while in prison; offenses committed post-release, reincarcerations, parole information (including entry into drug abuse treatment).
Biological Specimens
In addition to the self-report interview, self-report standardized measures, and corroborating staff ratings discussed above, biological specimens (urine samples) will be collected on half of the subjects using a random sampling procedure. Urine samples test for a wide array of substances, but are valid for drug use only in the preceding 48-72 hours. Urine specimens will be collected at T1, T2, T3 and T4. The project will also use urine tests (administered selectively) that can be obtained from the CDOC-RIS.

Full Information

First Posted
November 3, 2005
Last Updated
July 19, 2011
Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00249561
Brief Title
Colorado Women's TC Project
Official Title
Women's Prison TC: Outcomes, Process & Economic Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The major aim of the project is to document and evaluate two treatments for female offenders with substance abuse problems (TC and cognitive behavioral), simultaneously studying the process of treatment, and relating treatment process to treatment outcome.
Detailed Description
The number and proportion of substance abusing women in prison have been increasing, creating a need for programs tailored to this population, and for evaluation of such programs. The specific aims of this project were: (1) to conduct a rigorous evaluation of the effectiveness of prison TC treatment for substance abusing women offenders; (2) to investigate the treatment process for the target population and to explore the relationship between the process and outcome of treatment; (3) to evaluate the cost and cost effectiveness of treatment; and (4) to assess issues in obtaining and making use of aftercare services and provide information regarding the additional contribution of aftercare treatment. The core investigation, over four years (n=600), randomly assigned female substance abusing offenders at the Denver Women's Correctional Facility to either a TC program, Recovery By Choice, the experimental (E) condition (n=300), or to a non-TC standard program, the comparison (C) condition (n=300). The study predicted better outcomes for the TC group in an intent-to-treat analysis of all study entrants. The Aim 4 supplementary study of aftercare, with no random assignment, followed program completers from E and C as they entered mandatory aftercare, choosing either TC aftercare or a non-TC treatment alternative. The research employed a prospective, longitudinal, repeated measures assessment with five points (baseline, 6-, 12-, and 18-months post-baseline) to assess standard outcome measures (e.g., drug use, crime, and employment), as well as specific measures of particular concern to female offenders (e.g., trauma and abuse). In addition to self-report data, urine toxicology and criminal record data were obtained. The study collected process data, guided by the Texas Christian University Treatment Process Model, The project contributes to a theoretical advance in our understanding of the process of treatment for women offenders in prison TCs. It advances research through a rigorous study of TC prison program effectiveness for women compared to another, routine treatment. It guides practice by delineating treatment elements for women and by examining the effectiveness of a TC program that organizes these elements. Finally, it integrates outcome and economic analysis to inform policy and planning about the effectiveness of the TC treatment under study. Perhaps most significantly, it tests TC principles and methods found effective for substance-abusing male offenders, which have been adapted for women, thereby increasing the potential utility of these strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
610 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery by Choice
Arm Type
Experimental
Arm Description
A modified Therapeutic Community program.
Arm Title
Intensive Outpatient Program
Arm Type
Active Comparator
Arm Description
Designed to address substance abuse and criminality, with a focus on prevention of relapse and recidivism.
Intervention Type
Behavioral
Intervention Name(s)
Recovery by Choice
Intervention Description
The experimental condition, the modified TC, was a 6- to 9-month program located in a separate 72-bed housing unit within the prison. Inmates progressed through four program stages with upper level inmates functioning as peer mentors for newer members. The modified, comprehensive TC treatment program focused on increasing awareness and understanding of female roles and relationships as they relate to addiction and drugs used and abused, and emotional and behavioral coping skills. Program elements addressed issues of substance abuse, relapse prevention, mental health, criminal thinking and behavior, coping with trauma and abuse, and parenting skills. All treatment staff received special training related to working with women exposed to trauma and abuse, making the program "trauma informed" and "trauma sensitive."
Intervention Type
Behavioral
Intervention Name(s)
The Intensive Outpatient Program (IOP)
Intervention Description
The control condition, known at the prison as the Intensive Outpatient Program (IOP), was designed to address substance abuse and criminality, with a focus on prevention of relapse and recidivism. The IOP substance abuse treatment curriculum, designed for delivery over 15 weeks, consisted of a 90-hour manual-driven course (Strategies for Self-Improvement and Change, Wanburg & Milkman, 1998), which employed a cognitive behavioral format to address underlying issues of substance use/abuse and criminal behavior.
Primary Outcome Measure Information:
Title
Intake CTCR Baseline & Follow-Up Protocol (CTCR Protocol)
Description
The CTCR Protocol (CTCR, 1992) is a structured interview that was adapted from the ASI and DATAR for use in community treatment and the criminal justice system; additional versions, including Green's Trauma Scale (Green, 1996) to measure trauma and abuse, have been developed for baseline, during treatment and community follow-up with women. It assesses the following domains: socio-demographic background, substance use, psychosocial functioning, criminal justice involvement, education, employment, parenting, peer and family support, and health.
Time Frame
At entry
Title
Beck Depression Inventory-II (BDI-II)
Description
The BDI-II (Beck, Steer, & Brown, 1996). The BDI measures three domains of depression: Somatic Depression, Cognitive Depression and Total Depression Scores, consistent with the DSM-IV criteria for depressive disorders.
Time Frame
At entry
Title
Rosenberg Self-Esteem (SES)
Description
The SES (Rosenberg, 1965) is the most widely used global measure of self-esteem,
Time Frame
At entry
Title
Symptom CheckList 90-R (SCL90-R)
Description
The SCL90-R (Derogatis, 1983) measures 9 domains including: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, providing a global index of distress: Global Severity Index (GSI).
Time Frame
At entry
Title
Diagnostic Interview Survey (DIS-IV)
Description
The DIS-IV (Robins et al., 1995) is a structured clinical interview to generate DSM-IV lifetime and current psychiatric and substance use/abuse diagnoses.
Time Frame
At entry
Title
Parenting Practices Scale (PPS)
Description
The PPS measures the parenting practices among parents of children under age 12.
Time Frame
At entry
Title
Social Support Arizona Social Support Scale (ASSIS)
Description
The ASSIS (Barrera, 1980; Barrera, Sandier, & Ramsay, 1981; Stevens, Murphy, & McGrath, 2000) measures social support networks with a series of questions regarding the people who are important to the client and the number of ways they support the individual. Areas covered by the scale include: intimate interaction, material aid, advice, positive feedback, physical assistance, social participation, negative interactions, and personal characteristic of network members.
Time Frame
At entry
Title
Texas Christian University Resident Evaluation of Self and Treatment (TCU-REST)
Description
The TCU-REST (Knight, Simpson & Chatham, 1997; Simpson & Knight, 1998) provides measures of client process and progress in treatment in the following domains: psychological functioning (including scales for self-esteem, depression, anxiety, self-efficacy, and decision-making confidence.
Title
Client Assessment Inventory (CAI)
Description
The CAI (Kressel, 1998) measures client perceptions of progress and participation in TC treatment, in 14 domains: maturity, responsibility, values, drug/criminal life style, maintaining images, work attitude, social skills, cognitive skills, emotional skills, sense of well being, accepting program structure and philosophy, participating in group activities, attachment to, and investment in, the program. The latter two scales provide measures of participation and commitment.
Title
Circumstances, Motivation and Readiness (CMR)
Description
The CMR assesses motivation and readiness for treatment (Circumstances 1 (external influences to enter or remain in treatment), Circumstances 2, (external influences to leave treatment), and Motivation (internal recognition of the need to change).
Title
Cost: Drug Abuse Treatment Cost Analysis Program (DATCAP)
Title
Service Utilization Form (SUF)
Title
Partner Abuse Scales (PAS)
Description
The PAS (Hudson, 1990) consists of two matched pairs of scales, each consisting of 25 Likert type items. The Partner Abuse: Physical (RASPH) and the Partner Abuse: Non-Physical (PASNP) measure self-reports of physical and non-physical abuse between partners.
Secondary Outcome Measure Information:
Title
Colorado Department of Corrections Record Information System (CDOC-RIS)
Description
The CDOC-RIS will be accessed to gather data on the following measures: current charge on which incarceration is based; other previous charges; current sentence; status of violent offenses; urine toxicological information on drug and alcohol use; medical information; dates of prior incarcerations; disciplinary reports; all services received while in prison; offenses committed post-release, reincarcerations, parole information (including entry into drug abuse treatment).
Title
Biological Specimens
Description
In addition to the self-report interview, self-report standardized measures, and corroborating staff ratings discussed above, biological specimens (urine samples) will be collected on half of the subjects using a random sampling procedure. Urine samples test for a wide array of substances, but are valid for drug use only in the preceding 48-72 hours. Urine specimens will be collected at T1, T2, T3 and T4. The project will also use urine tests (administered selectively) that can be obtained from the CDOC-RIS.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: at least 6 months, and no more than 24 months, remaining until parole eligibility; a CDOC "Standardized Offender Assessment" (SOA; CDOC, 2004) score indicative of serious substance abuse problems mandating substance abuse treatment; and a security risk level classification of minimum, minimum-restricted, or medium (necessary to permit participation in treatment). Exclusion criteria: less than 6 months, or more than 24 months, remaining until parole eligibility; a CDOC "Standardized Offender Assessment" (SOA; CDOC, 2004) score that is not indicative of serious substance abuse problems mandating substance abuse treatment; or a security risk level classification above medium.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnn Y Sacks, Ph.D.
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Women's Correctional Facility
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18683197
Citation
Sacks JY, McKendrick K, Hamilton Z, Cleland CM, Pearson FS, Banks S. Treatment outcomes for female offenders: relationship to number of Axis I diagnoses. Behav Sci Law. 2008;26(4):413-34. doi: 10.1002/bsl.828.
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Colorado Women's TC Project

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