Mental IllnessSMHPNCT02990026
Specialty Mental Health Probation in North Carolina
A study testing Specialty Mental Health Probation in people with Mental Illness and Substance Use, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Illness, Substance Use, Criminal Behavior
- What is being tested?
- Specialty Mental Health Probation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2016to 30 Sep 2019
- Phase
- Interventional
- 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27759
About this study
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.
Read the 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.
- Conditions
- Mental Illness, Substance Use, Criminal Behavior
- Being tested
- Specialty Mental Health Probation
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialty Mental Health ProbationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: Specialty Mental Health Probation |
| Control | Active comparator | Standard probation - delivered by a standard probation officer - care as usual Receives: Behavioral: Specialty Mental Health Probation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism
Recidivism, probation revocation or other criminal justice events
Measured: 24 months
Secondary outcomes (7)
Mental health service engagement
Administrative data from local and state mental health authorities will be accessed to assess mental health service utilization
Measured: 24 months
Mental health functioning
Assessment of mental health functioning - standardized measure (Symptom Checklist - SCL-10-R)
Measured: 6 months
Social support
Assessment of social support - standardized measure (Medical Outcomes Study - Social Support Scale [MOS])
Measured: 6 months
Life events checklist
Assessment of traumatic life events - standardized measure (Life Events Checklist - LEC-5 Standard)
Measured: Baseline
Substance use
Criminal justice contact related to substance use - via administrative records
Measured: 24 months
Social network (researcher-created measure of social support network)
Access and utilization of pro-social network as measured by a researcher-created instrument
Measured: 6 months
Dual Role Relationship Inventory (DRRI, standardized measure)
Assessment of probationer's relationship with probation officer
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start22 Sep 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Department of Public Safety
- Responsible party
- Sponsor
- Investigators
- Gary Cuddeback, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990026
- Sponsor's protocol ID
- 14-0492
- Other IDs
- 2015-SM-BX-0004
- Acronym
- SMHP
- Status last verified
- Mar 2020
- First submitted
- 6 Dec 2016
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialty Mental Health Probation in North Carolina
- ClinicalTrials.gov ID
- NCT02990026
- Acronym / sponsor ID
- SMHP / 14-0492
- Conditions
- Mental Illness, Substance Use, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Department of Public Safety
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 12 Dec 2016 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Specialty Mental Health ProbationSpecialty 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. |
| Control | Active comparator | Behavioral: Specialty Mental Health ProbationStandard probation - delivered by a standard probation officer - care as usual |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Specialty Mental Health ProbationSpecialty 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 | Behavioural | Control, Treatment |
Primary outcome
Recidivism
Time frame: 24 months
Recidivism, probation revocation or other criminal justice events
7 secondary outcomes
Mental health service engagement
Time frame: 24 months
Mental health functioning
Time frame: 6 months
Social support
Time frame: 6 months
Life events checklist
Time frame: Baseline
Substance use
Time frame: 24 months
Social network (researcher-created measure of social support network)
Time frame: 6 months
Dual Role Relationship Inventory (DRRI, standardized measure)
Time frame: baseline, 6 months
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 17 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Gary Cuddeback principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialty Mental Health Probation in people with Mental Illness and Substance Use, run by University of North Carolina, Chapel Hill 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 1 inclusion and 1 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 17 Mar 2020. 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.
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?
Recidivism (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2020.