- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01334164
Recovery Management Checkups for Women Offenders (RMC-WO)
July 27, 2015 updated by: Chestnut Health Systems
Recovery Management Checkups for Women Offenders Experiment
The proposed study is designed to test the effectiveness of recovery management checkups for women offenders (RMC-WO) released from jail to provide continuity of care immediately upon release and to help them manage their long-term recovery.
The hypotheses in the first phase were: 1)women assigned to RMC (versus control) will a) return to treatment sooner after the initial release from jail and b) be more likely to receive treatment in the 90 days after release from jail; 2)women who received treatment in the first 90 days post release (vs.
no treatment) will be more likely to sustain their abstinence through 90 days post release from a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates; 3)women who maintained their abstinence from any alcohol and other drugs through the first 90 days post release (vs.
any relapse) will be less likely to have a) unprotected sex, b) commit any other illegal activity, and d) be re-incarcerated in jail or prison.
In the second phase repeated exposure to these efforts on a quarterly basis is expected to further strengthen each of these effects.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The components of the recovery management checkups will include: on-going monitoring via a re-entry meeting, two monthly meetings and quarterly assessments for 3 years, personalized feedback on substance use and high risk behaviors, linkage to community-based substance abuse treatment (when needed), on-site HIV booster sessions (when needed), and treatment engagement and retention support.
Motivational interviewing will provide the therapeutic approach to transition women from one step of the change process to another.
Combined, these components and therapeutic milieu afford an opportunity for immediate linkage to community-based treatment and HIV prevention as well as ongoing monitoring for relapse and early re-intervention for both substance use and HIV risk behaviors (both public health priorities).
Study Type
Interventional
Enrollment (Actual)
480
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60610
- Chestnut Health Systems-Lighthouse Institute
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Normal, Illinois, United States, 61761
- Chestnut Health Systems
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Phase 1
Inclusion Criteria:
- adult women offenders with substance problems re-entering the community from county jail programs
Exclusion Criteria:
- had not used substances in the 90 days before incarceration
- had no abuse/dependence symptoms
- were under 18 years old
- lived or planned to move outside Chicago within the next 12 months
- were not fluent in English or Spanish
- were cognitively unable to provide informed consent and were released before the 14th day of incarceration Phase 2
Inclusion Criteria:
- released to the community
- agreed to participate in the study
- completed the initial interview
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recovery Management Checkup (RMC)
Women assigned to the RMC condition met with a linkage manager after each research interview.
When a woman reported substance use, HIV risk behavior or illegal activity, the linkage manager used motivational interviewing to: provide feedback regarding her current substance use, HIV risk behavior or illegal activity, discuss barriers that prevented her from stopping each activity and ways of avoiding them in the future, and assess and discuss her level of motivation for change.
Linkage managers also scheduled treatment appointments, accompanied the women to treatment intake and stayed through the process and implemented an Engagement and Retention Protocol designed to improve retention rates.
For women who refused the treatment option, the linkage manager and participant agreed upon an Alternative Action plan, which included various behaviors the woman had agreed to engage in to reduce or stop her substance use, HIV risk, or her participation in illegal activity.
|
Women assigned to the RMC condition met with a linkage manager after each research interview.
When a woman reported substance use, HIV risk behavior or illegal activity, the linkage manager used motivational interviewing to: provide feedback regarding her current substance use, HIV risk behavior or illegal activity, discuss barriers that prevented her from stopping each activity and ways of avoiding them in the future, and assess and discuss her level of motivation for change.
Linkage managers also scheduled treatment appointments, accompanied the women to treatment intake and stayed through the process and implemented an Engagement and Retention Protocol designed to improve retention rates.
For women who refused the treatment option, the linkage manager and participant agreed upon an Alternative Action plan, which included various behaviors the woman had agreed to engage in to reduce or stop her substance use, HIV risk, or her participation in illegal activity.
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Active Comparator: Outcome Monitoring
Outcome monitoring only, however participates are still able (and do) enter treatment on their own.
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Outcome monitoring only, however participates are still able (and do) enter treatment on their own
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to treatment re-entry
Time Frame: 3 years post release
|
Time from first relapse (after release from jail) to first treatment re-entry measured in days and censored at the last observation.
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3 years post release
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Any Treatment
Time Frame: Quarterly and over 3 years
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Receipt of any substance abuse treatment during each quarter and overall all observed quarters.
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Quarterly and over 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abstinence
Time Frame: Quarterly and over 3 years
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Based on no self reported use and clean urine tests at 30, 60 and 90 days post release for: a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates
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Quarterly and over 3 years
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HIV risk behaviors and Recidivism
Time Frame: Quarterly and over 3 years
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Based on no self report post release of a) unprotected sex defined as having vaginal, anal or oral sex without a barrier like a male condom, women's condom, or dental dam.; b) no self reported illegal activity other than drug use and no arrest; and c) no days in jail or prison.
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Quarterly and over 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
April 11, 2011
First Submitted That Met QC Criteria
April 12, 2011
First Posted (Estimate)
April 13, 2011
Study Record Updates
Last Update Posted (Estimate)
July 29, 2015
Last Update Submitted That Met QC Criteria
July 27, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 1037-0905
- R01DA021174 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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