Re-Entry MTC for Offenders With MICA Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT00249756
First received: November 3, 2005
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Mental Disorders
Substance-Related Disorders
Behavioral: Re-entry Modified Therapeutic Community (Re-entry MTC)
Behavioral: Parole Supervision and Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Re-Entry MTC for Offenders With MICA Disorders

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • CTCR Baseline & Follow-Up Protocol (CTCR Protocol) [ Time Frame: Baseline and at 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    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.

  • Colorado Department of Corrections Record Information System (CDOC-RIS) [ Time Frame: At 6, 12, and 18 months ] [ Designated as safety issue: Yes ]

    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).


  • Biological Specimens [ Time Frame: At 12 and 18 months ] [ Designated as safety issue: No ]
    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.

  • Diagnostic Interview Survey-IV (DIS-IV) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.

  • Beck Depression Inventory-II (BDI-II) [ Time Frame: At baseline and 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    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.

  • Symptom Checklist 90-R (SCL90-R) [ Time Frame: At baseline and 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    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).

  • Rosenberg Self-Esteem (R-SES) [ Time Frame: At baseline and 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    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.

  • Measures of Social Network (adapted) [ Time Frame: At baseline and 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    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)

  • Client Assessment Inventory (CAI) & Staff Assessment Summary (SAS) [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]

    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.


  • Therapeutic Community Scale of Essential Elements Questionnaire(SEEQ) [ Time Frame: administered monthly over the first six months of the project and quarterly thereafter ] [ Designated as safety issue: No ]
    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.

  • Treatment Services Review (TSR) [ Time Frame: administered monthly over the first six months of the project and quarterly thereafter ] [ Designated as safety issue: No ]
    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).

  • Program Monitoring Form (PMF) [ Time Frame: administered monthly over the first six months of the project and quarterly thereafter ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Employment Survey (QES) [ Time Frame: At baseline and 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    The measures of employment (duration and stability, hours worked, income, and occupational prestige) will be adapted from the 1977 QES (Quinn & Staines, 1979).

  • The Quality of Life Interview (QLI) — short form [ Time Frame: At baseline and 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
    The original QLI (Lehman, Passidente & Hawker, 1986) was modified and shortened by NDRI staff. The instrument measures clients' satisfaction with aspects of their lives important to successful functioning in the community (e.g., family, social relations, finances, health).


Enrollment: 610
Study Start Date: August 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Re-entry Modified Therapeutic Community (Re-entry MTC) Behavioral: Re-entry Modified Therapeutic Community (Re-entry MTC)
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.
Active Comparator: Parole Supervision and Case Management Behavioral: Parole Supervision and Case Management
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.

Detailed Description:

Offenders having both mental illness and chemical abuse (MICA) disorders are a population of interest, in part because their special needs place exceptional demands on criminal justice and treatment systems, as well as on individuals and families. This study examines the crucial point of transition from prison to the community, where continued treatment for offenders is generally considered necessary to sustain gains made by prison treatment efforts, and to achieve successful outcomes. The project has two specific aims; Aim 1 is to test the effectiveness of Re entry MTC treatment relative to a control condition, and Aim 2 is to 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.

On their release from prison, male offenders with MICA disorders who elect to participate in this study (N = 332), will be placed in either the experimental condition, (E) Re-entry Modified Therapeutic Community (Re-entry MTC) or the control condition, (C) Parole Supervision and Case Management currently provided, using a randomized block assignment procedure. The research employs a prospective, longitudinal, repeated measures assessment with five data collection points: baseline (Time 1, or T1) corresponding to entry into the Community Corrections facility and at 3 (T2), 6 (T3), 12 (T4), and 18 (T5) months post-baseline. The major study hypothesis is that the E condition (compared to the C condition) will produce significantly greater improvement in the presenting problems of the study participants, as measured by substance use, mental health symptoms, and criminal activities.

This project will advance scientific knowledge through a controlled study of the effectiveness of the MTC model, with demonstrated success in community settings, as a re-entry strategy for offenders with MICA disorders, thereby expanding the range of treatment models available to such clients in the community. In addition, the study will examine the degree to which prior prison treatment moderates the effectiveness of the Re-entry MTC, or the extent to which positive outcomes are independent of the type of treatment received during the prior incarceration. This distinction will inform program planning by establishing the value of MTC treatment in prison plus MTC during re-entry versus MTC re-entry treatment alone. Finally, the study tests a specific hypothesis about the degree to which the effectiveness of Re-entry MTC treatment is mediated by client progress during reentry, which will increase our understanding of the relationship between progress in treatment and post-treatment outcomes for offenders with MICA disorders.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The study has no exclusion criteria other than programmatic criteria that exclude offenders who constitute a threat to themselves or to others in the community, as determined by the Community Corrections Board at the time the offender is placed in a Community Corrections facility.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249756

Locations
United States, Colorado
Arrowhead Correctional Facility
Caqon City, Colorado, United States, 81215 0300
San Carlos Correctional Facility
Pueblo, Colorado, United States, 81002
Sterling Correctional Facility
Sterling, Colorado, United States, 80751
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Stanley Sacks, Ph.D. National Development and Research Institutes, Inc.
  More Information

Additional Information:
No publications provided by National Development and Research Institutes, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT00249756     History of Changes
Other Study ID Numbers: NIDA-19982-1, R01DA019982, R01-19982-1
Study First Received: November 3, 2005
Last Updated: August 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Development and Research Institutes, Inc.:
Criminal Justice

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 24, 2014