- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01334164
Recovery Management Checkups for Women Offenders (RMC-WO)
27 de julho de 2015 atualizado 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
480
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to treatment re-entry
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Abstinence
Prazo: 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
Prazo: 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
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Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2007
Conclusão Primária (Real)
1 de junho de 2015
Conclusão do estudo (Real)
1 de junho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
11 de abril de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de abril de 2011
Primeira postagem (Estimativa)
13 de abril de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
29 de julho de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de julho de 2015
Última verificação
1 de julho de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 1037-0905
- R01DA021174 (Concessão/Contrato do NIH dos EUA)
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