SchizophreniaR-FACTNCT07592884
Rochester Forensic Assertive Community Treatment Model in Minnesota
A study testing R-FACT intervention and Standard Outpatient Treatment in people with Schizophrenia and Bipolar Disorder, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Criminal Behavior
- What is being tested?
- R-FACT intervention and Standard Outpatient Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 5 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Criminal Behavior
- Being tested
- R-FACT intervention, Standard Outpatient Treatment
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-FACT interventionBehavioural
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.
Standard Outpatient TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 (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. Receives: 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. Receives: Behavioral: Standard Outpatient Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to 24 months after randomization
Secondary outcomes (4)
Mean Total Number of Arrests During the 24 Month Follow Up Period
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.
Measured: Randomization to 24 months after randomization
Mean Total Number of Convictions During the 24 Month Follow Up Period
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.
Measured: Randomization to 24 months after randomization
Mean Total Number of Community Supervision Violations During the 24 Month Follow Up Period
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.
Measured: Randomization to 24 months after randomization
Mean Total Number of Jail Stays During the 24 Month Follow Up Period
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.
Measured: Randomization to 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start23 Jan 2020
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Arnold Ventures
- Responsible party
- Principal investigator, Steven Lamberti, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592884
- Sponsor's protocol ID
- STUDY00001721
- Other IDs
- AWD00002196
- Acronym
- R-FACT
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Rochester Forensic Assertive Community Treatment Model in Minnesota
- ClinicalTrials.gov ID
- NCT07592884
- Acronym / sponsor ID
- R-FACT / STUDY00001721
- Conditions
- Schizophrenia, Bipolar Disorder, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Arnold Ventures
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| R-FACT intervention | Experimental | Behavioral: R-FACT interventionParticipants 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. |
| Standard Outpatient treatment | Active comparator | Behavioral: Standard Outpatient TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-FACT interventionA 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. | Behavioural | R-FACT intervention |
| Standard Outpatient TreatmentRoutine 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. | Behavioural | Standard Outpatient treatment |
Primary outcome
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.
4 secondary outcomes
Mean Total Number of Arrests During the 24 Month Follow Up Period
Time frame: 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
Mean Total Number of Community Supervision Violations During the 24 Month Follow Up Period
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R-FACT intervention and Standard Outpatient Treatment in people with Schizophrenia and Bipolar Disorder, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Number of Days Incarcerated During the 24 Month Follow Up Period (time frame: Randomization to 24 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.