<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990026</url>
  </required_header>
  <id_info>
    <org_study_id>14-0492</org_study_id>
    <secondary_id>2015-SM-BX-0004</secondary_id>
    <nct_id>NCT02990026</nct_id>
  </id_info>
  <brief_title>Specialty Mental Health Probation in North Carolina</brief_title>
  <acronym>SMHP</acronym>
  <official_title>Specialty Mental Health Probation in North Carolina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Department of Public Safety</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specialty mental health probation for offenders with severe mental illness has been widely&#xD;
      disseminated; however, randomized studies are needed to determine its effectiveness. The&#xD;
      purpose of the study is to test the feasibility and efficacy of specialty mental health&#xD;
      probation (SMHP) for probationers with mental illness in North Carolina. 320 adult&#xD;
      probationers with mental illness in will be randomly assigned to specialty mental health&#xD;
      probation (experimental condition) or usual probation (control condition). Probationers&#xD;
      assigned to the experimental condition will be supervised by specialty mental health&#xD;
      probation officers, who will have reduced caseloads and advanced training in mental health&#xD;
      and other topics. Probationers assigned to the control condition will receive standard&#xD;
      probation. Criminal justice and mental health outcomes will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specialty mental health probation for offenders with severe mental illness has been widely&#xD;
      disseminated; however, randomized studies are needed to determine its effectiveness. The&#xD;
      purpose of the study is to test the feasibility and efficacy of specialty mental health&#xD;
      probation (SMHP) for probationers with mental illness in North Carolina. 320 adult&#xD;
      probationers with severe mental illness in will be randomly assigned to receive specialty&#xD;
      mental health probation (experimental condition) or standard probation (control condition).&#xD;
      Probationers assigned to the experimental condition will be supervised by specialty mental&#xD;
      health probation officers, who will have reduced caseloads and advanced training in mental&#xD;
      health and other topics. Probationers assigned to the control condition will receive standard&#xD;
      probation. Criminal justice and mental health outcomes will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2016</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recidivism</measure>
    <time_frame>24 months</time_frame>
    <description>Recidivism, probation revocation or other criminal justice events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental health service engagement</measure>
    <time_frame>24 months</time_frame>
    <description>Administrative data from local and state mental health authorities will be accessed to assess mental health service utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health functioning</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of mental health functioning - standardized measure (Symptom Checklist - SCL-10-R)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social support</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of social support - standardized measure (Medical Outcomes Study - Social Support Scale [MOS])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life events checklist</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of traumatic life events - standardized measure (Life Events Checklist - LEC-5 Standard)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance use</measure>
    <time_frame>24 months</time_frame>
    <description>Criminal justice contact related to substance use - via administrative records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social network (researcher-created measure of social support network)</measure>
    <time_frame>6 months</time_frame>
    <description>Access and utilization of pro-social network as measured by a researcher-created instrument</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual Role Relationship Inventory (DRRI, standardized measure)</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Assessment of probationer's relationship with probation officer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Mental Illness</condition>
  <condition>Substance Use</condition>
  <condition>Criminal Behavior</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard probation - delivered by a standard probation officer - care as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Specialty Mental Health Probation</intervention_name>
    <description>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</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Qualifying diagnosis of severe mental illness - schizophrenia, bipolar disorder, major&#xD;
             depression, post-traumatic stress disorder + on probation in North Carolina + capable&#xD;
             of passing study competency quiz administered by the research team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary Cuddeback</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>March 13, 2020</last_update_submitted>
  <last_update_submitted_qc>March 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990026
org study id: 14-0492
secondary id: 2015-SM-BX-0004
nct id: NCT02990026
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recidivism
time frame: 24 months
description: Recidivism, probation revocation or other criminal justice events
measure: Mental health service engagement
time frame: 24 months
description: Administrative data from local and state mental health authorities will be accessed to assess mental health service utilization
measure: Mental health functioning
time frame: 6 months
description: Assessment of mental health functioning - standardized measure (Symptom Checklist - SCL-10-R)
measure: Social support
time frame: 6 months
description: Assessment of social support - standardized measure (Medical Outcomes Study - Social Support Scale [MOS])
measure: Life events checklist
time frame: Baseline
description: Assessment of traumatic life events - standardized measure (Life Events Checklist - LEC-5 Standard)
measure: Substance use
time frame: 24 months
description: Criminal justice contact related to substance use - via administrative records
measure: Social network (researcher-created measure of social support network)
time frame: 6 months
description: Access and utilization of pro-social network as measured by a researcher-created instrument
measure: Dual Role Relationship Inventory (DRRI, standardized measure)
time frame: baseline, 6 months
description: Assessment of probationer's relationship with probation officer
arm group label: Treatment
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Active Comparator
description: Standard probation - delivered by a standard probation officer - care as usual
intervention type: Behavioral
intervention name: Specialty Mental Health Probation
description: 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
arm group label: Control
arm group label: Treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gary Cuddeback
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
sharing ipd: No