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- Ensayo clínico NCT01334164
Recovery Management Checkups for Women Offenders (RMC-WO)
27 de julio de 2015 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Actual)
480
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Illinois
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Chicago, Illinois, Estados Unidos, 60610
- Chestnut Health Systems-Lighthouse Institute
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Normal, Illinois, Estados Unidos, 61761
- Chestnut Health Systems
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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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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|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to treatment re-entry
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Abstinence
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2007
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
11 de abril de 2011
Primero enviado que cumplió con los criterios de control de calidad
12 de abril de 2011
Publicado por primera vez (Estimar)
13 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1037-0905
- R01DA021174 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .