Recovery Management Checkup (RMC)Phase 2RMC-WONCT01334164
Recovery Management Checkups for Women Offenders
A Phase 2 study testing Recovery Management Checkups and Outcome Monitoring in people with Recovery Management Checkup (RMC) and Outcome Monitoring, run by Chestnut Health Systems at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recovery Management Checkup (RMC), Outcome Monitoring
- What is being tested?
- Recovery Management Checkups and Outcome Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Jun 2015
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult women offenders with substance problems re-entering the community from county jail programs
- released to the community
- agreed to participate in the study
- completed the initial interview
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chestnut Health Systems-Lighthouse Institute
Chicago, Illinois, 60610
Chestnut Health Systems
Normal, Illinois, 61761
About this study
Official title: 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.
Read the 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).
- Being tested
- Recovery Management Checkups, Outcome Monitoring
- Keywords
- substance use disorder, offenders, reentry, HIV risk behavior, recidivism
- Medical subject headings
- Substance-Related Disorders, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Management CheckupsBehavioural
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.
Outcome MonitoringOther
Outcome monitoring only, however participates are still able (and do) enter treatment on their own
| Study group | Role | What they receive |
|---|---|---|
| Recovery Management Checkup (RMC) | Experimental | 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. Receives: Behavioral: Recovery Management Checkups |
| Outcome Monitoring | Active comparator | Outcome monitoring only, however participates are still able (and do) enter treatment on their own. Receives: Other: Outcome Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment re-entry
Time from first relapse (after release from jail) to first treatment re-entry measured in days and censored at the last observation.
Measured: 3 years post release
Any Treatment
Receipt of any substance abuse treatment during each quarter and overall all observed quarters.
Measured: Quarterly and over 3 years
Secondary outcomes (2)
Abstinence
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
Measured: Quarterly and over 3 years
HIV risk behaviors and Recidivism
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.
Measured: Quarterly and over 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startJul 2007
- Primary completionJun 2015
- Study completionJun 2015
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 Recovery Management Checkup (RMC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Haymarket Center, Cook County Sheriff's Women's Justice Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334164
- Sponsor's protocol ID
- 1037-0905
- Other IDs
- R01DA021174
- Acronym
- RMC-WO
- Status last verified
- Jul 2015
- First submitted
- 11 Apr 2011
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scott CK, Dennis ML. The first 90 days following release from jail: findings from the Recovery Management Checkups for Women Offenders (RMCWO) experiment. Drug Alcohol Depend. 2012 Sep 1;125(1-2):110-8. doi: 10.1016/j.drugalcdep.2012.03.025. Epub 2012 Apr 27.
PubMed 22542465
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Management Checkups for Women Offenders Experiment
- ClinicalTrials.gov ID
- NCT01334164
- Acronym / sponsor ID
- RMC-WO / 1037-0905
- Keywords
- substance use disorder, offenders, reentry, HIV risk behavior, recidivism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- Haymarket Center, Cook County Sheriff's Women's Justice Services
- Study start
- Jul 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Apr 2011 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Management Checkup (RMC) | Experimental | Behavioral: Recovery Management CheckupsWomen 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. |
| Outcome Monitoring | Active comparator | Other: Outcome MonitoringOutcome monitoring only, however participates are still able (and do) enter treatment on their own. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult women offenders with substance problems re-entering the community from county jail programs
- released to the community
- agreed to participate in the study
- completed the initial interview
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Recovery Management CheckupsWomen 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. | Behavioural | Recovery Management Checkup (RMC) |
| Outcome MonitoringOutcome monitoring only, however participates are still able (and do) enter treatment on their own | Other | Outcome Monitoring |
Primary outcome
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.
Any Treatment
Time frame: Quarterly and over 3 years
Receipt of any substance abuse treatment during each quarter and overall all observed quarters.
2 secondary outcomes
Abstinence
Time frame: Quarterly and over 3 years
HIV risk behaviors and Recidivism
Time frame: Quarterly and over 3 years
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 29 Jul 2015.
- Derived from this study: PubMed 22542465Scott CK, Dennis ML. The first 90 days following release from jail: findings from the Recovery Management Checkups for Women Offenders (RMCWO) experiment. Drug Alcohol Depend. 2012 Sep 1;125(1-2):110-8. doi: 10.1016/j.drugalcdep.2012.03.025. Epub 2012 Apr 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recovery Management Checkups and Outcome Monitoring in people with Recovery Management Checkup (RMC) and Outcome Monitoring, run by Chestnut Health Systems at 2 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 4 inclusion and 6 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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to treatment re-entry (time frame: 3 years post release). The study lists 2 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 NCT01334164, 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 29 Jul 2015.