NCT00249756

Brief Summary

The purpose of this study is to examine the transition of offenders with both mental illness and chemical abuse (MICA) disorders from prison to the community, where continued treatment is generally considered necessary to sustain gains made by prison treatment, and to achieve successful outcomes. The project will determine the effectiveness of a modified therapeutic community (Re-Entry MTC) approach as compared to the case management and parole supervision currently provided. The study will also assess the relative impact on treatment outcomes of the type of treatment received while in prison and of the progress achieved in re-entry treatment.

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 not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

August 1, 2005

Completed
3 months 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
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

4.7 years

First QC Date

November 3, 2005

Last Update Submit

August 29, 2013

Conditions

Keywords

Criminal Justice

Outcome Measures

Primary Outcomes (12)

  • CTCR Baseline & Follow-Up Protocol (CTCR Protocol)

    The CTCR Protocol (CTCR, 1992) is a structured interview adapted from the ASI and DATAR for use in community treatment and the criminal justice system. The CTCR Protocol assesses these domains: socio-demographic background, substance use, psychosocial functioning, criminal justice involvement, education, employment, parenting, peer and family relations, and health. Measures of independent living skills and community functioning will be added.

    Baseline and at 3, 6, 12, and 18 months

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

    The CDOC-RIS will provide data on: charge on which incarceration is based; 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 substance abuse treatment). Taking appropriate steps to protect inmate confidentiality, study staff will obtain the basic digital records data (and appropriate updates).

    At 6, 12, and 18 months

  • Biological Specimens

    Samples for urine toxicology tests will be collected on all subjects at T4 \& T5, to corroborate self-report data and to provide a separate outcome measure. A reliable laboratory (e.g., Dominion Diagnostics) will test specimens for marijuana, cocaine, opiates, amphetamines, barbiturates, benzodiazepines, and ethanol; these tests are accurate for use in the preceding 48-72 hours.

    At 12 and 18 months

  • Diagnostic Interview Survey-IV (DIS-IV)

    The DIS-IV (Robins, Cottler, Bucholz \& Compton, 1995) is a structured clinical interview to generate DSM-IV lifetime and current psychiatric and substance use/abuse diagnoses. The DIS-IV requires interviewer training, but not clinical expertise.

    At baseline

  • Beck Depression Inventory-II (BDI-II)

    The BDI-II (Beck, Steer, \& Brown, 1996) measures Somatic Depression \& Cognitive Depression and provides a Total Depression Score, consistent with the DSM-IV criteria for depressive disorders.

    At baseline and 3, 6, 12, and 18 months

  • Symptom Checklist 90-R (SCL90-R)

    The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI).

    At baseline and 3, 6, 12, and 18 months

  • Rosenberg Self-Esteem (R-SES)

    The R-SES (Rosenberg, 1965) is the most widely used global measure of self-esteem, reflecting the MTC emphasis on building self-esteem, and provides positive measures of psychological status to augment the symptom pictures obtained by the other standardized psychological measures.

    At baseline and 3, 6, 12, and 18 months

  • Measures of Social Network (adapted)

    The study will employ measures of social network adapted from existing sociometric studies to assess the building of a supportive community during and post re-entry treatment (e.g., Longabaugh et al., 1993; Neaigus et al., 1996; Rosenbaum, Nuttbrock \& Magura, 1997) and to ask respondents about their most important social networks based on contact in the last 30 days. These measures are accompanied by available software for sociometric analysis (e.g., UCINET)

    At baseline and 3, 6, 12, and 18 months

  • Client Assessment Inventory (CAI) & Staff Assessment Summary (SAS)

    The CAI and SAS (Kressel, 1998) measure client and staff perceptions of client 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.

    At 3 and 6 months

  • Therapeutic Community Scale of Essential Elements Questionnaire(SEEQ)

    The study will use the SEEQ (Melnick \& De Leon, 1999; Melnick et al., 2000) to capture the congruence between the program as implemented and the TC model, and using special MTC re-entry scales to describe the re-entry program.

    administered monthly over the first six months of the project and quarterly thereafter

  • Treatment Services Review (TSR)

    The TSR (McLellan et al., 1989) is a self-report instrument that includes items on the number of times the subject received any of five types of specialized treatment services for psychological problems during a given time period (30 days).

    administered monthly over the first six months of the project and quarterly thereafter

  • Program Monitoring Form (PMF)

    The PMF (Sacks, 1995) lists specific interventions and identifies three critical components for each intervention. The PMF will be adapted to assess intervention activities and components within each intervention and administered by research staff to clients in both E and C conditions.

    administered monthly over the first six months of the project and quarterly thereafter

Secondary Outcomes (2)

  • Quality of Employment Survey (QES)

    At baseline and 3, 6, 12, and 18 months

  • The Quality of Life Interview (QLI) - short form

    At baseline and 3, 6, 12, and 18 months

Study Arms (2)

Re-entry Modified Therapeutic Community (Re-entry MTC)

EXPERIMENTAL
Behavioral: Re-entry Modified Therapeutic Community (Re-entry MTC)

Parole Supervision and Case Management

ACTIVE COMPARATOR
Behavioral: Parole Supervision and Case Management

Interventions

In general, the MTC program model applies three fundamental adjustments - increased flexibility, decreased intensity, and greater individualization. The central TC feature is retained; the MTC, like all TC programs, seeks to develop a subculture where clients learn through self-help and affiliation with the community to foster change in themselves and others. From this base (as elaborated below), further adaptations for the population of offenders with MICA disorders were incorporated to include an emphasis on modifying criminal thinking and behavior; on recognizing and responding to the interrelationship of substance abuse, mental illness, and criminality (triple recovery); and on using strategies for symptom management.

Re-entry Modified Therapeutic Community (Re-entry MTC)

Recognizing the complexity of issues facing offenders returning to the community, and the importance of continuity of care, the CDOC established a system of aftercare substance abuse services for offenders on parole or placed in Community Corrections facilities. The statewide treatment options for the offenders consist of a network of community-based clinics and halfway houses throughout Colorado that provide substance abuse services and mental health services. Parole officers and Community Corrections case managers monitor treatment compliance to support participation in prescribed services.

Parole Supervision and Case Management

Eligibility Criteria

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

You may qualify if:

  • Male offenders with serious mental illness and co-occurring chemical abuse (MICA) disorders, as the term is currently applied in the CDOC Chemical abuse consists of any substance use or dependence disorder\[s\] diagnosis. Serious mental disorder\[s\] diagnosis includes DSM IV categories for: Bipolar Mood Disorders; Major Depressive Disorder; Paranoid/Delusional Disorders; Schizophrenic Disorders; Schizoaffective Disorder; and Post Traumatic Stress Disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arrowhead Correctional Facility

Caqon City, Colorado, 81215 0300, United States

Location

San Carlos Correctional Facility

Pueblo, Colorado, 81002, United States

Location

Sterling Correctional Facility

Sterling, Colorado, 80751, United States

Location

Related Publications (1)

  • Sacks S, Chaple M, Sacks JY, McKendrick K, Cleland CM. Randomized trial of a reentry modified therapeutic community for offenders with co-occurring disorders: crime outcomes. J Subst Abuse Treat. 2012 Apr;42(3):247-59. doi: 10.1016/j.jsat.2011.07.011. Epub 2011 Sep 22.

MeSH Terms

Conditions

Mental DisordersSubstance-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Stanley Sacks, Ph.D.

    National Development and Research Institutes, Inc.

    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

November 3, 2005

First Posted

November 7, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations