NCT00249561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
610

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

5.8 years

First QC Date

November 3, 2005

Last Update Submit

July 19, 2011

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (13)

  • 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.

    At entry

  • 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.

    At entry

  • Rosenberg Self-Esteem (SES)

    The SES (Rosenberg, 1965) is the most widely used global measure of self-esteem,

    At entry

  • 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).

    At entry

  • 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.

    At entry

  • Parenting Practices Scale (PPS)

    The PPS measures the parenting practices among parents of children under age 12.

    At entry

  • 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.

    At entry

  • 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 Outcomes (2)

  • Colorado Department of Corrections Record Information System (CDOC-RIS)

  • Biological Specimens

Study Arms (2)

Recovery by Choice

EXPERIMENTAL

A modified Therapeutic Community program.

Behavioral: Recovery by Choice

Intensive Outpatient Program

ACTIVE COMPARATOR

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

Behavioral: The Intensive Outpatient Program (IOP)

Interventions

Recovery by ChoiceBEHAVIORAL

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."

Recovery by Choice
The Intensive Outpatient Program (IOP)BEHAVIORAL

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.

Intensive Outpatient Program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Women's Correctional Facility

Denver, Colorado, 80239, United States

Location

Related Publications (1)

  • 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.

    PMID: 18683197RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • JoAnn Y Sacks, Ph.D.

    National Development and Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

September 1, 2001

Primary Completion

July 1, 2007

Study Completion

September 1, 2007

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)