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- Klinische proef NCT01334164
Recovery Management Checkups for Women Offenders (RMC-WO)
27 juli 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
480
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60610
- Chestnut Health Systems-Lighthouse Institute
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Normal, Illinois, Verenigde Staten, 61761
- Chestnut Health Systems
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
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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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Actieve vergelijker: 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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time to treatment re-entry
Tijdsspanne: 3 years post release
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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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Abstinence
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2007
Primaire voltooiing (Werkelijk)
1 juni 2015
Studie voltooiing (Werkelijk)
1 juni 2015
Studieregistratiedata
Eerst ingediend
11 april 2011
Eerst ingediend dat voldeed aan de QC-criteria
12 april 2011
Eerst geplaatst (Schatting)
13 april 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
29 juli 2015
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2015
Laatst geverifieerd
1 juli 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 1037-0905
- R01DA021174 (Subsidie/contract van de Amerikaanse NIH)
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