Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01313052
Other study ID # 5R34MH078003-03
Secondary ID 5R34MH078003-03
Status Completed
Phase Phase 3
First received March 8, 2011
Last updated February 24, 2017
Start date May 2008
Est. completion date May 2014

Study information

Verified date February 2017
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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, Assisted Outpatient Treatment, or Criminal Procedure Law status.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Monroe County Jail Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Terminated NCT03230097 - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year Phase 2
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Recruiting NCT02874573 - Tocilizumab in Schizophrenia Phase 1
Completed NCT02906553 - The Role of Nitric Oxide in Cognition in Schizophrenia N/A
Terminated NCT02584114 - Brain Effects of Memory Training in Early Psychosis N/A
Completed NCT01981356 - Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis Phase 0
Terminated NCT02841956 - Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Recruiting NCT02009969 - Serial Comparisons of Abdominal and Neurological MRI Scans N/A
Recruiting NCT02848469 - Irish Omega-3 Study Phase 2
Completed NCT02648321 - Motivational Intervention for Physical Activity in Psychosis N/A
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00484302 - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis N/A
Completed NCT00844922 - Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842) Phase 2
Completed NCT00455234 - Rapid Tranquillization Trial: TREC-India II Phase 3
Completed NCT00130923 - Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Phase 4
Completed NCT00130676 - A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression Phase 3