Psychotic DisordersPhase 3FACTNCT01313052
Forensic Assertive Community Treatment: An Emerging Model of Service Delivery
A Phase 3 study testing Forensic Assertive Community Treatment (FACT) and Enhanced Treatment as Usual in people with Psychotic Disorders, run by University of Rochester at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Forensic Assertive Community Treatment (FACT) and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2014
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
- 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.
Read the 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:
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
- 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.
- Conditions
- Psychotic Disorders
- Being tested
- Forensic Assertive Community Treatment (FACT), Enhanced Treatment as Usual
- Keywords
- Psychotic, Criminal
- Medical subject headings
- Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forensic Assertive Community Treatment (FACT)Behavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: For the one year subjects are in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMay 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Steven Lamberti, University of Rochester
- Investigators
- J Steven Lamberti, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313052
- Sponsor's protocol ID
- 5R34MH078003-03
- Other IDs
- 5R34MH078003-03
- Acronym
- FACT
- Status last verified
- Feb 2017
- First submitted
- 8 Mar 2011
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21459994Lamberti, 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forensic Assertive Community Treatment: An Emerging Model of Service Delivery
- ClinicalTrials.gov ID
- NCT01313052
- Acronym / sponsor ID
- FACT / 5R34MH078003-03
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic, Criminal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Mar 2011 (estimated)
- 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.
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:
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
- 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.
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:
- FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in promoting treatment adherence among high-risk adults with psychotic disorders.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forensic Assertive Community Treatment (FACT) | Experimental | 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 | Active comparator | Behavioral: Enhanced Treatment as UsualIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | Forensic Assertive Community Treatment (FACT) |
| Enhanced Treatment as UsualIndividuals 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. | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Jail Recidivism
Time frame: For the one year subjects are in the study.
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.
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.
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 28 Feb 2017.
- Background: PubMed 21459994Lamberti 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.
- BackgroundLamberti, 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.
- Results publicationLamberti, 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.
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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.
J Steven Lamberti, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Forensic Assertive Community Treatment (FACT) and Enhanced Treatment as Usual in people with Psychotic Disorders, 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 2 inclusion and 3 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 28 Feb 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Jail Recidivism (time frame: For the one year subjects are in the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313052, which also lists 3 linked publications.
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 28 Feb 2017.