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Recovery Management Checkups for Women Offenders (RMC-WO)

27. juli 2015 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

480

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forente stater, 60610
        • Chestnut Health Systems-Lighthouse Institute
      • Normal, Illinois, Forente stater, 61761
        • Chestnut Health Systems

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: Outcome Monitoring
Outcome monitoring only, however participates are still able (and do) enter treatment on their own.
Outcome monitoring only, however participates are still able (and do) enter treatment on their own

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to treatment re-entry
Tidsramme: 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.
3 years post release
Any Treatment
Tidsramme: Quarterly and over 3 years
Receipt of any substance abuse treatment during each quarter and overall all observed quarters.
Quarterly and over 3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Abstinence
Tidsramme: Quarterly and over 3 years
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
Quarterly and over 3 years
HIV risk behaviors and Recidivism
Tidsramme: Quarterly and over 3 years
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.
Quarterly and over 3 years

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2007

Primær fullføring (Faktiske)

1. juni 2015

Studiet fullført (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først innsendt

11. april 2011

Først innsendt som oppfylte QC-kriteriene

12. april 2011

Først lagt ut (Anslag)

13. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. juli 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1037-0905
  • R01DA021174 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Recovery Management Checkups

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