- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
New York
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Rochester, New York, Spojené státy, 14642
- University of Rochester Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Total Number of Days Incarcerated During the 24 Month Follow Up Period
Časové okno: 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.
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Randomization to 24 months after randomization
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Total Number of Arrests During the 24 Month Follow Up Period
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Randomization to 24 months after randomization
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00001721
- AWD00002196 (Jiné číslo grantu/financování: Arnold Ventures)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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