- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07592884
Rochester Forensic Assertive Community Treatment Model in Minnesota (R-FACT)
A Randomized Controlled Trial of the Rochester Forensic Assertive Community Treatment Model in Minnesota
This study evaluates the Rochester Forensic Assertive Community Treatment (R-FACT) model in Minnesota. R-FACT is an enhanced version of Assertive Community Treatment designed to support individuals with serious mental illness who are involved in the criminal justice system.
Participants were randomly assigned to receive either the R-FACT intervention or standard outpatient mental health services. The study examines whether R-FACT reduces criminal justice involvement, improves mental health outcomes, and enhances community functioning compared to usual care over a 24-month follow-up period.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
The R-FACT intervention includes a multidisciplinary team approach with reduced caseloads, enhanced supervision, and collaboration with criminal justice stakeholders.
This randomized controlled trial evaluates the effectiveness of the Rochester Forensic Assertive Community Treatment (R-FACT) model in Minnesota. R-FACT is a modified Assertive Community Treatment (ACT) model developed to address the needs of individuals with serious mental illness who are at high risk for criminal justice involvement. The model integrates best practices in community mental health (high-fidelity ACT) with best practices in community correctional supervision (Probation officers trained in Effective Practices in Community Supervision - EPICS) The study was conducted across two counties in Minnesota and enrolled adults with serious mental illness who were on probation or undergoing correctional facility release to probation. Participants were randomized to either the R-FACT intervention or standard outpatient mental health treatment.
The R-FACT intervention consists of a high-fidelity ACT team that collaborates closely with specially assigned probation officers who provide community correctional oversight of all R-FACT service recipients. The comparator group received usual care through existing outpatient mental health services along with standard probation.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New York
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Rochester, New York, Stati Uniti, 14642
- University of Rochester Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Age 18 or older.
- DSM-5 diagnosis of a psychotic disorder, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features.
- Adequate command of English to understand study instructions.
- Capacity to provide informed consent.
- Under community correctional supervision or undergoing prison release planning at the time of enrollment.
Exclusion Criteria:
- Age under 18.
- Lack of a psychotic disorder diagnosis.
- Inability to speak English.
- Lack of capacity to provide informed consent.
- Absence of community correctional supervision or of release planning.
- Presence of legal oversight in the community from a source other than probation or community corrections. Examples include having legal oversight from a mental health court, a drug court, or from an assisted outpatient treatment (AOT) program.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Standard Outpatient treatment
Participants assigned to this arm received standard outpatient mental health treatment available in the community.
This includes routine psychiatric care and case management services provided through existing outpatient systems without the enhanced structure and supervision of the R-FACT model.
|
Routine outpatient mental health services delivered through existing community systems, including standard psychiatric care and case management without the enhanced structure or intensity of the R-FACT model.
|
|
Sperimentale: R-FACT intervention
Participants assigned to this arm received the Rochester Forensic Assertive Community Treatment (R-FACT) intervention.
R-FACT is a modified Assertive Community Treatment (ACT) model designed for individuals with serious mental illness involved in or at risk of involvement in the criminal justice system.
The R-FACT intervention includes a multidisciplinary treatment team with high fidelity to the ACT model (e.g.
intensive staffing, assertive outreach, 24-7 availability, comprehensive services) that worked in close partnership with specially assigned probation officers over a 24-month period.
|
A structured, team-based model of care adapted from Assertive Community Treatment (ACT) that provides intensive, community-based psychiatric services with integrated supervision and coordination with criminal justice and social service systems.
The model emphasizes reduced caseloads, frequent participant contact, continuity of care, and collaborative problem solving between mental health and criminal justice staff with an emphasis on finding therapeutic alternatives to punishment.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Total Number of Days Incarcerated During the 24 Month Follow Up Period
Lasso di tempo: Randomization to 24 months after randomization
|
Incarceration days are measured using administrative correctional records.
For each participant, the total number of days incarcerated during the 24 month follow up period is calculated from correctional database records.
The outcome is reported as the mean total number of incarceration days per participant within each study arm.
Higher values indicate more time spent incarcerated, and lower values indicate less time spent incarcerated.
|
Randomization to 24 months after randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Total Number of Arrests During the 24 Month Follow Up Period
Lasso di tempo: Randomization to 24 months after randomization
|
Arrests are measured using administrative criminal justice records.
For each participant, all arrests occurring during the 24 month follow up period are counted.
The outcome is reported as the mean total number of arrests per participant within each study arm.
Higher values indicate more arrests.
|
Randomization to 24 months after randomization
|
|
Mean Total Number of Convictions During the 24 Month Follow Up Period
Lasso di tempo: Randomization to 24 months after randomization
|
Convictions are measured using administrative criminal justice records.
For each participant, all convictions occurring during the 24 month follow up period are counted.
The outcome is reported as the mean total number of convictions per participant within each study arm.
Higher values indicate more convictions.
|
Randomization to 24 months after randomization
|
|
Mean Total Number of Community Supervision Violations During the 24 Month Follow Up Period
Lasso di tempo: Randomization to 24 months after randomization
|
Community supervision violations are measured using administrative criminal justice records.
For each participant, all probation or parole violations occurring during the 24 month follow up period are counted.
The outcome is reported as the mean total number of violations per participant within each study arm.
Higher values indicate more violations.
|
Randomization to 24 months after randomization
|
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Mean Total Number of Jail Stays During the 24 Month Follow Up Period
Lasso di tempo: Randomization to 24 months after randomization
|
Jail stays are measured using correctional administrative records.
For each participant, the number of separate jail admissions occurring during the 24 month follow up period is counted.
The outcome is reported as the mean total number of jail stays per participant within each study arm.
Higher values indicate more jail admissions.
|
Randomization to 24 months after randomization
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00001721
- AWD00002196 (Altro numero di sovvenzione/finanziamento: Arnold Ventures)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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