A Randomized Controlled Trial of the Rochester Forensic Assertive Community Treatment Model in Minnesota

NCT07592884 | Completed DMC

• 2 other identifiers: STUDY00001721AWD00002196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Criminal Behavior; Schizophrenia; Bipolar Disorder; Serious Mental Illnes

Outcome Measures

Primary Outcomes (1)

• Mean Total Number of Days Incarcerated During the 24 Month Follow Up Period

  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

Secondary Outcomes (4)

• Mean Total Number of Arrests During the 24 Month Follow Up Period

  Randomization to 24 months after randomization

• Mean Total Number of Convictions During the 24 Month Follow Up Period

  Randomization to 24 months after randomization

• Mean Total Number of Community Supervision Violations During the 24 Month Follow Up Period

  Randomization to 24 months after randomization

• Mean Total Number of Jail Stays During the 24 Month Follow Up Period

  Randomization to 24 months after randomization

Study Arms (2)

R-FACT intervention

EXPERIMENTAL

Participants assigned to this arm received the Rochester Forensic Assertive Community Treatment (R-FACT) intervention. R-FACT is a modified Assertive Community Treatment model designed for individuals with serious mental illness involved in or at risk of involvement in the criminal justice system. The intervention includes a multidisciplinary team approach with reduced caseloads, intensive community-based psychiatric care, enhanced supervision, and coordination with criminal justice and social service systems over a 24-month period.

Behavioral: R-FACT intervention

Standard Outpatient treatment

ACTIVE COMPARATOR

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.

Behavioral: Standard Outpatient Treatment

Interventions

R-FACT intervention BEHAVIORAL

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, and continuity of care.

R-FACT intervention

Standard Outpatient Treatment BEHAVIORAL

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.

Standard Outpatient treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Arnold Ventures: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Criminal Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was open-label. Participants and care providers were aware of treatment assignment due to the nature of the intervention. Outcome data were obtained from administrative databases, reducing the risk of assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Department of Psychiatry, Administration (SMD)

Model Details: Participants were randomized to one of two groups: the Rochester Forensic Assertive Community Treatment (R-FACT) intervention or standard outpatient mental health treatment. Outcomes were compared between groups over a 24-month follow-up period.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: January 23, 2020
• Primary Completion: April 5, 2025
• Study Completion: April 5, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-04

Locations

US (1)