<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/NCT03826420</url>
  </required_header>
  <id_info>
    <org_study_id>BOTEC PADOC SCF</org_study_id>
    <nct_id>NCT03826420</nct_id>
  </id_info>
  <brief_title>Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole</brief_title>
  <official_title>Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Botec Analysis, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennsylvania Department of Corrections</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bureau of Justice Assistance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 research project will study the outcomes of medium- to high-risk parolees with a history&#xD;
      of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair&#xD;
      parole.&#xD;
&#xD;
      The research goals are to:&#xD;
&#xD;
        -  Determine the effectiveness of SCF parole in reducing recidivism among medium- to&#xD;
           high-risk parolees with a history of substance abuse in Pennsylvania.&#xD;
&#xD;
        -  Determine the minimum effective sanction in response to a violation that will bring&#xD;
           parolees into compliance with the conditions of their parole.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 15, 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>Single (Participant)</masking>
    <masking_description>Participants (parolees) will not be notified as to which arm they are enrolled.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Revocation Rate</measure>
    <time_frame>9 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>9 Months</time_frame>
    <description>Total number of days incarcerated in jail or prison per parolee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New Charges</measure>
    <time_frame>9 Months</time_frame>
    <description>Number of new charges per parolee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Positive Drug Tests</measure>
    <time_frame>9 Months</time_frame>
    <description>Percentage of random and scheduled drug tests that result in a positive reading for illicit drugs</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Substance Abuse</condition>
  <condition>Criminal Behavior</condition>
  <arm_group>
    <arm_group_label>Secure Confinement Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parolees assigned to this group will be assigned sanctions that include secure confinement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Work Release Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parolees assigned to this group will be assigned sanctions that include work-release.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GPS Supervision Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parolees assigned to this group will be assigned sanctions that include GPS supervision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCF Supervision with Secure Confinement Sanctioning</intervention_name>
    <description>Parolees assigned to this group will, in the face of a violation, be given a sanction that involves secure confinement.</description>
    <arm_group_label>Secure Confinement Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCF Supervision with Work Release Sanctioning</intervention_name>
    <description>Parolees assigned to this group will, in the face of a violation, be given a sanction that involves work-release.</description>
    <arm_group_label>Work Release Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCF Supervision with GPS Supervision Sanctioning</intervention_name>
    <description>Parolees assigned to this group will, in the face of a violation, be given a sanction that involves GPS supervision.</description>
    <arm_group_label>GPS Supervision Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Assigned to the Pittsburgh District&#xD;
&#xD;
          -  Allegheny County resident&#xD;
&#xD;
          -  Has at least 2 years left on supervision&#xD;
&#xD;
          -  Had a prior drug or alcohol related sanction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sex offender&#xD;
&#xD;
          -  Reentrants assigned to the Special Needs Unit&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Mark AR Kleiman</last_name>
    <role>Principal Investigator</role>
    <affiliation>BOTEC Analysis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clarissa Manning</last_name>
    <phone>(424) 262-8064</phone>
    <email>clarissa.manning@botecanalysis.com</email>
  </overall_contact>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 7, 2019</last_update_submitted>
  <last_update_submitted_qc>March 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03826420
org study id: BOTEC PADOC SCF
nct id: NCT03826420
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research project will study the outcomes of medium- to high-risk parolees with a history
      of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair
      parole.

      The research goals are to:

        -  Determine the effectiveness of SCF parole in reducing recidivism among medium- to
           high-risk parolees with a history of substance abuse in Pennsylvania.

        -  Determine the minimum effective sanction in response to a violation that will bring
           parolees into compliance with the conditions of their parole.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants (parolees) will not be notified as to which arm they are enrolled.
measure: Revocation Rate
time frame: 9 Months
description: Percentage of subjects in each condition who are revoked from parole and returned to prison
measure: Days Incarcerated
time frame: 9 Months
description: Total number of days incarcerated in jail or prison per parolee
measure: New Charges
time frame: 9 Months
description: Number of new charges per parolee
measure: Percent Positive Drug Tests
time frame: 9 Months
description: Percentage of random and scheduled drug tests that result in a positive reading for illicit drugs
arm group label: Secure Confinement Group
arm group type: Experimental
description: Parolees assigned to this group will be assigned sanctions that include secure confinement.
arm group label: Work Release Group
arm group type: Experimental
description: Parolees assigned to this group will be assigned sanctions that include work-release.
arm group label: GPS Supervision Group
arm group type: Experimental
description: Parolees assigned to this group will be assigned sanctions that include GPS supervision.
arm group label: Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: SCF Supervision with Secure Confinement Sanctioning
description: Parolees assigned to this group will, in the face of a violation, be given a sanction that involves secure confinement.
arm group label: Secure Confinement Group
intervention type: Behavioral
intervention name: SCF Supervision with Work Release Sanctioning
description: Parolees assigned to this group will, in the face of a violation, be given a sanction that involves work-release.
arm group label: Work Release Group
intervention type: Behavioral
intervention name: SCF Supervision with GPS Supervision Sanctioning
description: Parolees assigned to this group will, in the face of a violation, be given a sanction that involves GPS supervision.
arm group label: GPS Supervision Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark AR Kleiman
role: Principal Investigator
affiliation: BOTEC Analysis
last name: Clarissa Manning
phone: (424) 262-8064
email: clarissa.manning@botecanalysis.com
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Undecided