Mental DisordersNCT00249756
Re-Entry MTC for Offenders With MICA Disorders
A study testing Re-entry Modified Therapeutic Community (Re-entry MTC) and Parole Supervision and Case Management in people with Mental Disorders and Substance-Related Disorders, run by National Development and Research Institutes, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mental Disorders, Substance-Related Disorders
- What is being tested?
- Re-entry Modified Therapeutic Community (Re-entry MTC) and Parole Supervision and Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2005to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arrowhead Correctional Facility
Caqon City, Colorado, 81215 0300
San Carlos Correctional Facility
Pueblo, Colorado, 81002
Sterling Correctional Facility
Sterling, Colorado, 80751
About this study
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.
Read the 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.
- Conditions
- Mental Disorders, Substance-Related Disorders
- Being tested
- Re-entry Modified Therapeutic Community (Re-entry MTC), Parole Supervision and Case Management
- Keywords
- Criminal Justice
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-entry Modified Therapeutic Community (Re-entry MTC)Behavioural
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.
Parole Supervision and Case ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Re-entry Modified Therapeutic Community (Re-entry MTC) | Experimental | Not described Receives: Behavioral: Re-entry Modified Therapeutic Community (Re-entry MTC) |
| Parole Supervision and Case Management | Active comparator | Not described Receives: Behavioral: Parole Supervision and Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: administered monthly over the first six months of the project and quarterly thereafter
Secondary outcomes (2)
Quality of Employment Survey (QES)
The measures of employment (duration and stability, hours worked, income, and occupational prestige) will be adapted from the 1977 QES (Quinn \& Staines, 1979).
Measured: At baseline and 3, 6, 12, and 18 months
The Quality of Life Interview (QLI) - short form
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).
Measured: At baseline and 3, 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stanley Sacks, Ph.D., Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249756
- Sponsor's protocol ID
- NIDA-19982-1
- Other IDs
- R01DA019982, R01-19982-1
- Status last verified
- Aug 2013
- First submitted
- 3 Nov 2005
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21943810
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Entry MTC for Offenders With MICA Disorders
- ClinicalTrials.gov ID
- NCT00249756
- Acronym / sponsor ID
- NIDA-19982-1
- Conditions
- Mental Disorders, Substance-Related Disorders
- Keywords
- Criminal Justice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Re-entry Modified Therapeutic Community (Re-entry MTC) |
| Parole Supervision and Case ManagementRecognizing 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. | Behavioural | Parole Supervision and Case Management |
Primary outcome
CTCR Baseline & Follow-Up Protocol (CTCR Protocol)
Time frame: Baseline and at 3, 6, 12, and 18 months
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
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
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
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
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
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
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
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
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
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
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
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.
2 secondary outcomes
Quality of Employment Survey (QES)
Time frame: At baseline and 3, 6, 12, and 18 months
The Quality of Life Interview (QLI) - short form
Time frame: At baseline and 3, 6, 12, and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
- Derived from this study: PubMed 21943810Sacks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Sacks, Ph.D. principal investigator
National Development and Research Institutes, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-entry Modified Therapeutic Community (Re-entry MTC) and Parole Supervision and Case Management in people with Mental Disorders and Substance-Related Disorders, run by National Development and Research Institutes, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCR Baseline & Follow-Up Protocol (CTCR Protocol) (time frame: Baseline and at 3, 6, 12, and 18 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.