<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/NCT03812484</url>
  </required_header>
  <id_info>
    <org_study_id>CC100</org_study_id>
    <nct_id>NCT03812484</nct_id>
  </id_info>
  <brief_title>An Evaluation of the NJSPB SCF Project for Opioid-Involved High-Risk Parolees</brief_title>
  <official_title>An Evaluation of the New Jersey State Parole Board Swift, Certain, and Fair Project for Opioid-Involved High-Risk Parolees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Botec Analysis, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Botec Analysis, LLC</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>
      This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and&#xD;
      Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects&#xD;
      assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Swift, Certain, and Fair (SCF) Supervision Program - Including Project HOPE Program&#xD;
      provides funding to states, units of local government, territories, and federally recognized&#xD;
      Indian tribes (as determined by the Secretary of the Interior) in an effort to enhance public&#xD;
      safety, foster collaboration, and to improve the outcomes of individuals under the&#xD;
      supervision of community corrections. The goals of this program are to develop and enhance&#xD;
      SCF initiatives and implement the SCF model with fidelity, resulting in reduced recidivism&#xD;
      and better outcomes for program participants. SCF approaches are intended to: (a) improve&#xD;
      supervision strategies that reduce recidivism; (b) promote and increase collaboration among&#xD;
      agencies and officials who work in community corrections and related fields to enhance swift&#xD;
      and certain sanctions; (c) enhance the offenders' perception that the supervision decisions&#xD;
      are fair, consistently applied, and consequences are transparent; and (d) improve the&#xD;
      outcomes of individuals participating in these initiatives. The grantee will use awarded&#xD;
      grant funds to support programming that provides services to up to 75 opioid involved&#xD;
      parolees with services to divert them from a return to prison and manage underlying&#xD;
      addictions with a combination of behavioral therapy and medication assisted treatments. The&#xD;
      program combines sanctions with targeted reentry and treatment services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Revocation Rate</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of subjects in each condition who are revoked from parole and returned to prison</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Days Incarcerated</measure>
    <time_frame>12 months</time_frame>
    <description>Total number of days incarcerated in jail or prison</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New Charges</measure>
    <time_frame>12 months</time_frame>
    <description>Number of new charges</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Positive Drug Tests</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of random and scheduled drug tests that test positive for illicit drugs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Substance Abuse</condition>
  <condition>Criminal Behavior</condition>
  <arm_group>
    <arm_group_label>SCF Parole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parolee supervised under the SCF Supervision model</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parole-As-Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parolees are supervised under standard parole supervision practice in New Jersey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCF Supervision</intervention_name>
    <description>SCF Supervision entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). SCF Supervision includes regular random drug testing.</description>
    <arm_group_label>SCF Parole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parole-as-Usual</intervention_name>
    <description>Parolees are supervised under standard parole supervision practice in New Jersey</description>
    <arm_group_label>Parole-As-Usual</arm_group_label>
    <other_name>PAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be 18 years of age or older&#xD;
&#xD;
          -  Participants must have a history of opioid use or addiction&#xD;
&#xD;
          -  Participants have a history of parole violations or active parolees who are at risk&#xD;
             for violation (this can include anyone who is reentering the active population from&#xD;
             prison)&#xD;
&#xD;
          -  Participants reside in or are moving to Ocean County; and&#xD;
&#xD;
          -  Participants must have at least 6 months remaining on their Parole term&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clarissa Manning, MPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Botec Analysis, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New Jersey Reentry Corporation</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Botec Analysis, LLC</investigator_affiliation>
    <investigator_full_name>Clarissa Manning</investigator_full_name>
    <investigator_title>Director of Business Operations</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related 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/NCT03812484
org study id: CC100
nct id: NCT03812484
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and
      Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects
      assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU).
The Swift, Certain, and Fair (SCF) Supervision Program - Including Project HOPE Program
      provides funding to states, units of local government, territories, and federally recognized
      Indian tribes (as determined by the Secretary of the Interior) in an effort to enhance public
      safety, foster collaboration, and to improve the outcomes of individuals under the
      supervision of community corrections. The goals of this program are to develop and enhance
      SCF initiatives and implement the SCF model with fidelity, resulting in reduced recidivism
      and better outcomes for program participants. SCF approaches are intended to: (a) improve
      supervision strategies that reduce recidivism; (b) promote and increase collaboration among
      agencies and officials who work in community corrections and related fields to enhance swift
      and certain sanctions; (c) enhance the offenders' perception that the supervision decisions
      are fair, consistently applied, and consequences are transparent; and (d) improve the
      outcomes of individuals participating in these initiatives. The grantee will use awarded
      grant funds to support programming that provides services to up to 75 opioid involved
      parolees with services to divert them from a return to prison and manage underlying
      addictions with a combination of behavioral therapy and medication assisted treatments. The
      program combines sanctions with targeted reentry and treatment services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Revocation Rate
time frame: 12 months
description: Percentage of subjects in each condition who are revoked from parole and returned to prison
measure: Days Incarcerated
time frame: 12 months
description: Total number of days incarcerated in jail or prison
measure: New Charges
time frame: 12 months
description: Number of new charges
measure: Percent Positive Drug Tests
time frame: 12 months
description: Percentage of random and scheduled drug tests that test positive for illicit drugs
arm group label: SCF Parole
arm group type: Experimental
description: Parolee supervised under the SCF Supervision model
arm group label: Parole-As-Usual
arm group type: Active Comparator
description: Parolees are supervised under standard parole supervision practice in New Jersey.
intervention type: Behavioral
intervention name: SCF Supervision
description: SCF Supervision entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). SCF Supervision includes regular random drug testing.
arm group label: SCF Parole
intervention type: Behavioral
intervention name: Parole-as-Usual
description: Parolees are supervised under standard parole supervision practice in New Jersey
arm group label: Parole-As-Usual
other name: PAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clarissa Manning, MPP
role: Principal Investigator
affiliation: Botec Analysis, LLC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Botec Analysis, LLC
investigator full name: Clarissa Manning
investigator title: Director of Business Operations
mesh term: Substance-Related Disorders
sharing ipd: No