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Forensic Assertive Community Treatment: An Emerging Model of Service Delivery (FACT)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven Lamberti, University of Rochester
ClinicalTrials.gov Identifier:
NCT01313052
First received: March 8, 2011
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to enhanced outpatient treatment (close outpatient follow-up without judicial monitoring). Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor will be randomly assigned to each treatment group and followed for 12 months. Primary outcomes will include criminal justice and mental health service utilization rates, treatment adherence, psychiatric symptoms, substance abuse, homelessness, perceived coercion, and consumer satisfaction. Service utilization outcomes will be tracked using established mental health and criminal justice databases.

Hypotheses are:

  1. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
  2. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in preventing arrest, incarceration, emergency department and inpatient hospital use among high-risk adults with psychotic disorders.

Condition Intervention Phase
Individuals With a Psychotic Disorder, Who Are Facing Violation or Misdemeanor Charges, Who Are Not Currently Under Legal Leverage.
 Behavioral: Forensic Assertive Community Treatment (FACT)
Behavioral: Enhanced Treatment as Usual
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Forensic Assertive Community Treatment: An Emerging Model of Service Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Jail Recidivism [ Time Frame: For the one year subjects are in the study. ] [ Designated as safety issue: No ]
    The study will measure number of arrests, number of incarcerations, and total number of jail and/or prison days in the time frame described above.

  • Mental Health Service Utilization [ Time Frame: For the one year subjects are in the study. ] [ Designated as safety issue: No ]
    The study will measure number of hospitalizations, number of hospital days, number of emergency room visits, number of outpatient mental health visits as primary outcome measures, and treatment appointment adherence.


Enrollment: 53
Study Start Date: May 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Forensic Assertive Community Treatment (FACT)
Individuals in this arm will receive the services of an Assertive Community Treatment team and close supervision of a judge trained in the FACT model.
 Behavioral: Forensic Assertive Community Treatment (FACT)
Individuals in this arm will receive the services of an Assertive Community Treatment team and close supervision of a judge trained in the FACT model.
Active Comparator: Enhanced Treatment as Usual
Individuals in this arm of the study will receive an expedited appointment at a clinic specializing in the treatment of psychotic disorders. These individuals will receive the services of a therapist, psychiatrist, and case manager.
 Behavioral: Enhanced Treatment as Usual
Individuals in this arm of the study will receive an expedited appointment at a clinic specializing in the treatment of psychotic disorders. These individuals will receive the services of a therapist, psychiatrist, and case manager.

Detailed Description:

FACT (Forensic Assertive Community Treatment) is an adaptation of the Assertive Community Treatment (ACT) model that addresses a significant gap in our service delivery systems by targeting the interface between mental health and criminal justice services. ACT was originally developed to engage severely mentally ill adults in outpatient psychiatric treatment through the use of assertive outreach and comprehensive services. FACT adds legal leverage in the form of judicial monitoring to ACT, which is comprehensive, high intensity, mobile, psychiatric treatment.

The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to enhanced outpatient treatment (close outpatient follow-up without judicial monitoring). Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor will be randomly assigned to each treatment group and followed for 12 months. Primary outcomes will include criminal justice and mental health service utilization rates, treatment adherence, psychiatric symptoms, substance abuse, and homelessness. Service utilization outcomes will be tracked using established mental health and criminal justice databases.

Hypotheses are:

  1. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
  2. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in preventing arrest, incarceration, emergency department and inpatient hospital use among high-risk adults with psychotic disorders.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals diagnosed with any psychotic disorder such as Schizophrenia, Schizoaffective Disorder, Bipolar Disorder with Psychotic Features, Depressive Disorder with Psychotic Features, and Psychotic Disorder, Not Otherwise Specified.
  • Individuals currently facing misdemeanor or violation charges who have not yet been sentenced.

Exclusion Criteria:

  • Individuals do not have or cannot be diagnosed with a psychotic disorder.
  • Individuals currently facing felony charges
  • Individuals currently involved in any type of legal leverage including probation, parole, drug or mental health court supervision, Kendra's Law Assisted Outpatient Treatment, or CPL status.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313052

Locations
United States, New York
Monroe County Jail
Rochester, New York, United States, 14614
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: J Steven Lamberti, MD University of Rochester
  More Information

Publications:

Responsible Party: Steven Lamberti, Professor, Department of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT01313052     History of Changes
Other Study ID Numbers: 5R34MH078003-03, 5R34MH078003-03
Study First Received: March 8, 2011
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Psychotic
Criminal

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 18, 2013