- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Total Number of Days Incarcerated During the 24 Month Follow Up Period
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Total Number of Arrests During the 24 Month Follow Up Period
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
|
Mean Total Number of Jail Stays During the 24 Month Follow Up Period
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001721
- AWD00002196 (Other Grant/Funding Number: Arnold Ventures)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States
-
Ole Köhler-ForsbergAarhus University HospitalRecruiting
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Recruiting
-
Central Institute of Mental Health, MannheimRecruitingSchizophrenia | Treatment Resistant SchizophreniaGermany
-
Bradley LegaRecruiting
Clinical Trials on Standard Outpatient Treatment
-
Laura Belinda RizzoUniversità degli Studi 'G. d'Annunzio' Chieti e PescaraCompletedArthrosis of the KneeItaly
-
University Hospital Inselspital, BerneSchweizerische HerzstiftungCompletedStroke | Cerebrovascular Disorders | PreventionSwitzerland
-
Nova Scotia Health AuthorityCompletedEating DisordersCanada
-
Clinica Universidad de Navarra, Universidad de...RecruitingAcute Pulmonary Embolism | Outpatient TreatmentSpain
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Norwegian Foundation for Health and RehabilitationCompletedAnorexia Nervosa | Bulimia Nervosa | Eating Disorder | Personality DisorderNorway
-
Connolly Hospital BlanchardstownCompletedOutpatients General Surgery Virtual ClinicIreland
-
Hanoi Medical UniversityCompleted
-
Intermountain Health Care, Inc.Completed
-
Meshalkin Research Institute of Pathology of CirculationUnknownMyocardial Infarction | Cardiovascular Diseases | Coronary Artery DiseaseRussian Federation
-
Yolanda Schlumpf, PhDUniversity of Zurich; Clienia Littenheid AGCompletedComplex Posttraumatic Stress Disorder (cPTSD) | Dissociative Disorder Not Otherwise Specified (DDNOS) | Dissociative Identity Disorder (DID)Switzerland