Recovery Management Checkups for Women Offenders (RMC-WO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Haymarket Center
Cook County Sheriff's Women's Justice Services
Information provided by (Responsible Party):
Chestnut Health Systems
ClinicalTrials.gov Identifier:
NCT01334164
First received: April 11, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Recovery Management Checkup (RMC)
Outcome Monitoring
Behavioral: Recovery Management Checkups
Other: Outcome Monitoring
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recovery Management Checkups for Women Offenders Experiment

Resource links provided by NLM:


Further study details as provided by Chestnut Health Systems:

Primary Outcome Measures:
  • Time to treatment re-entry [ Time Frame: 3 years post release ] [ Designated as safety issue: No ]
    Time from first relapse (after release from jail) to first treatment re-entry measured in days and censored at the last observation.

  • Any Treatment [ Time Frame: Quarterly and over 3 years ] [ Designated as safety issue: No ]
    Receipt of any substance abuse treatment during each quarter and overall all observed quarters.


Secondary Outcome Measures:
  • Abstinence [ Time Frame: Quarterly and over 3 years ] [ Designated as safety issue: No ]
    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

  • HIV risk behaviors and Recidivism [ Time Frame: Quarterly and over 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 480
Study Start Date: July 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Recovery Management Checkups
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.
Active Comparator: Outcome Monitoring
Outcome monitoring only, however participates are still able (and do) enter treatment on their own.
Other: Outcome Monitoring
Outcome monitoring only, however participates are still able (and do) enter treatment on their own

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).

  Eligibility

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

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
  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: NCT01334164

Locations
United States, Illinois
Chestnut Health Systems-Lighthouse Institute
Chicago, Illinois, United States, 60610
Chestnut Health Systems
Normal, Illinois, United States, 61761
Sponsors and Collaborators
Chestnut Health Systems
Haymarket Center
Cook County Sheriff's Women's Justice Services
  More Information

No publications provided by Chestnut Health Systems

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT01334164     History of Changes
Other Study ID Numbers: 1037-0905, R01DA021174
Study First Received: April 11, 2011
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Chestnut Health Systems:
substance use disorder
offenders
reentry
HIV risk behavior
recidivism

ClinicalTrials.gov processed this record on September 22, 2014