- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990026
Specialty Mental Health Probation in North Carolina (SMHP)
March 13, 2020 updated by: University of North Carolina, Chapel Hill
Specialty mental health probation for offenders with severe mental illness has been widely disseminated; however, randomized studies are needed to determine its effectiveness.
The purpose of the study is to test the feasibility and efficacy of specialty mental health probation (SMHP) for probationers with mental illness in North Carolina.
320 adult probationers with mental illness in will be randomly assigned to specialty mental health probation (experimental condition) or usual probation (control condition).
Probationers assigned to the experimental condition will be supervised by specialty mental health probation officers, who will have reduced caseloads and advanced training in mental health and other topics.
Probationers assigned to the control condition will receive standard probation.
Criminal justice and mental health outcomes will be examined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Specialty mental health probation for offenders with severe mental illness has been widely disseminated; however, randomized studies are needed to determine its effectiveness.
The purpose of the study is to test the feasibility and efficacy of specialty mental health probation (SMHP) for probationers with mental illness in North Carolina.
320 adult probationers with severe mental illness in will be randomly assigned to receive specialty mental health probation (experimental condition) or standard probation (control condition).
Probationers assigned to the experimental condition will be supervised by specialty mental health probation officers, who will have reduced caseloads and advanced training in mental health and other topics.
Probationers assigned to the control condition will receive standard probation.
Criminal justice and mental health outcomes will be examined.
Study Type
Interventional
Enrollment (Actual)
311
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27759
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Qualifying diagnosis of severe mental illness - schizophrenia, bipolar disorder, major depression, post-traumatic stress disorder + on probation in North Carolina + capable of passing study competency quiz administered by the research team
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Specialty mental health probation - delivered by probation officers who receive specialized training and ongoing clinical consultation with a licensed mental health professional and who have reduced caseloads of exclusively mentally ill offenders.
|
Specialty mental health probation includes the following components: (1) exclusively mentally ill caseload of probationers; (2) reduced caseload of 40-45 probationers; (3) problem-solving supervision orientation; (4) ongoing training and consultation; and (5) greater connection with local mental health services
|
Active Comparator: Control
Standard probation - delivered by a standard probation officer - care as usual
|
Specialty mental health probation includes the following components: (1) exclusively mentally ill caseload of probationers; (2) reduced caseload of 40-45 probationers; (3) problem-solving supervision orientation; (4) ongoing training and consultation; and (5) greater connection with local mental health services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recidivism
Time Frame: 24 months
|
Recidivism, probation revocation or other criminal justice events
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health service engagement
Time Frame: 24 months
|
Administrative data from local and state mental health authorities will be accessed to assess mental health service utilization
|
24 months
|
Mental health functioning
Time Frame: 6 months
|
Assessment of mental health functioning - standardized measure (Symptom Checklist - SCL-10-R)
|
6 months
|
Social support
Time Frame: 6 months
|
Assessment of social support - standardized measure (Medical Outcomes Study - Social Support Scale [MOS])
|
6 months
|
Life events checklist
Time Frame: Baseline
|
Assessment of traumatic life events - standardized measure (Life Events Checklist - LEC-5 Standard)
|
Baseline
|
Substance use
Time Frame: 24 months
|
Criminal justice contact related to substance use - via administrative records
|
24 months
|
Social network (researcher-created measure of social support network)
Time Frame: 6 months
|
Access and utilization of pro-social network as measured by a researcher-created instrument
|
6 months
|
Dual Role Relationship Inventory (DRRI, standardized measure)
Time Frame: baseline, 6 months
|
Assessment of probationer's relationship with probation officer
|
baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gary Cuddeback, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2016
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimate)
December 12, 2016
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0492
- 2015-SM-BX-0004 (Other Identifier: UNC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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