NCT01313052

Brief Summary

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

6 years

First QC Date

March 8, 2011

Last Update Submit

February 24, 2017

Conditions

Keywords

PsychoticCriminal

Outcome Measures

Primary Outcomes (2)

  • Jail Recidivism

    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.

    For the one year subjects are in the study.

  • Mental Health Service Utilization

    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.

    For the one year subjects are in the study.

Study Arms (2)

Forensic Assertive Community Treatment (FACT)

EXPERIMENTAL

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)

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

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.

Forensic Assertive Community Treatment (FACT)

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.

Enhanced Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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, Assisted Outpatient Treatment, or Criminal Procedure Law status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monroe County Jail

Rochester, New York, 14614, United States

Location

Related Publications (3)

  • Lamberti JS, Deem A, Weisman RL, LaDuke C. The role of probation in forensic assertive community treatment. Psychiatr Serv. 2011 Apr;62(4):418-21. doi: 10.1176/ps.62.4.pss6204_0418.

    PMID: 21459994BACKGROUND
  • Lamberti, J., & Weisman, R. (2010). Forensic assertive community treatment: Origins, current practice, and future directions. In H. Dlugacz (Ed.), Reentry Planning for Offenders With Mental Disorders (1 ed., Vol. 1, pp. 145-169). Kingston, NJ: Civic Research Institute.

    BACKGROUND
  • Lamberti, JS. (2011). Legal Leverage in the Treatment of Adults With Severe Mental Illness, in Workplace Violence in Mental Health and General Health Care Settings. Pages 225 - 236. M. Privitera, editor. Jones and Bartlett, Pages 225-236.

    RESULT

MeSH Terms

Conditions

Psychotic DisordersMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • J Steven Lamberti, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Psychiatry

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 11, 2011

Study Start

May 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations