<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/NCT01670708</url>
  </required_header>
  <id_info>
    <org_study_id>2011-RY-BX-0003</org_study_id>
    <nct_id>NCT01670708</nct_id>
  </id_info>
  <brief_title>HOPE Demonstration Field Experiment Multisite Evaluation</brief_title>
  <official_title>Multisite Evaluation of the Honest Opportunity With Enforcement Demonstration Field Experiment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>U.S. Department of Justice</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement&#xD;
      Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control&#xD;
      trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program&#xD;
      provides strict oversight of probationers through a HOPE Court judge and intensive probation&#xD;
      supervision, including random drug testing, coupled with swift and certain sanctions in&#xD;
      response to positive results on random drug tests and other violations of conditions of&#xD;
      supervision. The HOPE DFE Evaluation is being conducted among probation populations in four&#xD;
      sites and will identify the effectiveness of swift and certain sanctions on targeted&#xD;
      outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and&#xD;
      secondary (revocation rates, jail days served, prison days sentenced).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration&#xD;
      Field Experiment (the HOPE DFE Evaluation) has four goals: (1) Design and implement a&#xD;
      randomization process in each of the four DFE sites; (2) Conduct a comprehensive process&#xD;
      evaluation to assess implementation fidelity and identify lessons learned that will enhance&#xD;
      future replications; (3) Conduct a rigorous experimental outcome evaluation to determine the&#xD;
      effect of the HOPE model and its components on individual probation outcomes; and (4) Conduct&#xD;
      a cost evaluation to assess the cost effectiveness of HOPE. The RCT will involve identifying&#xD;
      in each of four sites a pool of HOPE-eligible probationers who will be randomly assigned to&#xD;
      HOPE or to probation as usual (PAU). The evaluation will randomly assign approximately 400&#xD;
      eligible probationers to HOPE or PAU in each of the four sites for a total sample size of&#xD;
      1,600 (800 HOPE and 800 PAU). Criteria identifying the HOPE-eligible target population and&#xD;
      procedures to identify that population in a timely fashion randomly assigning HOPE-eligible&#xD;
      Probationers to HOPE or PAU have been identified. Random assignment will be accomplished&#xD;
      using evaluation-provided forms that include study identification numbers and the random&#xD;
      assignment that is covered by a scratch-off label. The assignment will be revealed only after&#xD;
      the individual has been provided the opportunity to participate in the evaluation and, with&#xD;
      consent, completed the baseline interview. The process evaluation/fidelity assessment&#xD;
      component will document the extent to which each program conforms to the HOPE model; document&#xD;
      the barriers, challenges, facilitators, and lessons learned during implementation to fill&#xD;
      gaps in the knowledge base as to what is required to set up a HOPE program; and provide&#xD;
      evidence as to the generalizability and sustainability of HOPE programs. This component will&#xD;
      also document the PAU control conditions in each site and will assess implementation fidelity&#xD;
      of evidence-based drug treatment programs. Implementation and process measures will be&#xD;
      collected through stakeholder interviews; observation of initial warning hearings and court&#xD;
      appearances; and review of court, probation, and HOPE project records. The process evaluation&#xD;
      will also document the PAU practices to identify intervention differences among the control&#xD;
      groups and to provide an opportunity to measure changes in practices that could signal&#xD;
      contamination of the control arm. Fidelity assessments of drug treatment programs will be&#xD;
      conducted using the Correctional Program Checklist. The outcome study will assess whether&#xD;
      HOPE participation improves appointment compliance, drug test results, rearrest rates,&#xD;
      revocation rates, jail days served, and prison days sentenced. In addition, the evaluation&#xD;
      will determine whether HOPE participation changes potential mediators including criminal&#xD;
      thinking/attitudes, perceptions of control and justice system fairness and legitimacy,&#xD;
      dynamic recidivism risk factors, and employment and housing stability. For the outcome study,&#xD;
      administrative data will provide information on appointment compliance, drug test results,&#xD;
      re-arrests, violations, revocations, and jail and prison days for all HOPE and PAU evaluation&#xD;
      participants. Interview data will be collected from evaluation participants at evaluation&#xD;
      enrollment and 6 months post-enrollment on measures that will facilitate understanding of the&#xD;
      nature of individual change associated with HOPE participation. All HOPE-eligible&#xD;
      Probationers who consent to study participation will complete an audio computer assisted self&#xD;
      interview (ACASI) at baseline and 6 months post baseline; a random sample of those completing&#xD;
      ACASI baseline interviews will be asked to participate in a twice-weekly series of&#xD;
      mini-interviews (telephone-ACASI or T-ACASI). Non-incarcerated individuals are being offered&#xD;
      $20 equivalent to complete the ACASI interview. Random drug tests on a subsample of HOPE and&#xD;
      PAU evaluation participants will be conducted in conjunction with the 6-month post-enrollment&#xD;
      interviews to provide a common measure of current drug use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">March 31, 2015</completion_date>
  <primary_completion_date type="Actual">March 31, 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Illegal drug use</measure>
    <time_frame>6 months</time_frame>
    <description>Multiple measures to include percent positive for (1) marijuana, (2) cocaine, (3) heroin, (4) methamphetamine, and (5) any illegal drug on an oral swab drug test administered in conjunction with the 6 month follow-up interview (subjects in the community, i.e. not jailed or institutionalized, only).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rearrest</measure>
    <time_frame>6 Months</time_frame>
    <description>Multiple measures to include (1) percent arrested within 6 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 6 months of baseline; and (5) percent arrested for (a) violent, and (b) property</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rearrest</measure>
    <time_frame>12 months</time_frame>
    <description>Multiple measures to include (1) percent arrested within 12 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 12 months of baseline; and (5) percent arrested for (a) violent, (b) property, and (c) drug offenses within 12 months of baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probation Appointment Compliance</measure>
    <time_frame>6 months</time_frame>
    <description>Number of missed appointments following baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probation Appointment Compliance</measure>
    <time_frame>12 months</time_frame>
    <description>Number of missed appointments following baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probation revocation</measure>
    <time_frame>6 months</time_frame>
    <description>Percent revoked from probation within 6 months following baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>jail days served</measure>
    <time_frame>6 months</time_frame>
    <description>Number of days served in jail within 6 months following baseline for (1) violation of conditions of probation; (2) arrest or charge for new offense; (3) sentence for new offense; and (4) total number of days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probation Revocation</measure>
    <time_frame>12 Months</time_frame>
    <description>Percent revoked from probation within 12 months following baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jail Days Served</measure>
    <time_frame>12 months</time_frame>
    <description>Number of days served in jail within 12 months following baseline for (1) violation of conditions of probation; (2) arrest or charge for new offense; (3) sentence for new offense; and (4) total number of days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prison Days Sentenced</measure>
    <time_frame>6 months</time_frame>
    <description>Number of days sentenced to prison within 6 months following baseline for (1) probation revocation; (2) conviction for a new offense; and (3) total of revocation and new conviction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prison Days Sentenced</measure>
    <time_frame>12 months</time_frame>
    <description>Number of days sentenced to prison within 12 months following baseline for (1) probation revocation; (2) conviction for a new offense; and (3) total of revocation and new conviction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1504</enrollment>
  <condition>Substance Use</condition>
  <condition>Criminal Recidivism</condition>
  <arm_group>
    <arm_group_label>HOPE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participation in HOPE program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probation as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participation in probation as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOPE</intervention_name>
    <description>HOPE Court Judge provides warning hearing; random drug testing; violation hearing and jail/other sanctions for failed drug test or failure to comply with other probation conditions.</description>
    <arm_group_label>HOPE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Probation as Usual</intervention_name>
    <description>Probation officer supervises following standard protocols.</description>
    <arm_group_label>Probation as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult probationers assessed as high risk for failure on probation (e.g., high&#xD;
             likelihood of new arrest, failure to comply with conditions) who live within the&#xD;
             geographic boundaries of the study site with at least 11.5 months remaining on their&#xD;
             probation sentence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Juveniles&#xD;
&#xD;
          -  live outside geographic boundaries&#xD;
&#xD;
          -  assigned to specialized probation caseloads (e.g., sex offender, DUI, mental health)&#xD;
&#xD;
          -  non-English speaking in some sites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela K Lattimore, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTI International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Court and Probation Office, Saline County</name>
      <address>
        <city>Benton</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salem County Probation Office, Massachusetts Salem District Court, Essex County Superior Court</name>
      <address>
        <city>Salem</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Court and Probation Office</name>
      <address>
        <city>Oregon City</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Court and Probation Office, Tarrant County</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Substance Use</keyword>
  <keyword>Illicit Drug Use</keyword>
  <keyword>Criminal Behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01670708
org study id: 2011-RY-BX-0003
nct id: NCT01670708
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement
      Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control
      trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program
      provides strict oversight of probationers through a HOPE Court judge and intensive probation
      supervision, including random drug testing, coupled with swift and certain sanctions in
      response to positive results on random drug tests and other violations of conditions of
      supervision. The HOPE DFE Evaluation is being conducted among probation populations in four
      sites and will identify the effectiveness of swift and certain sanctions on targeted
      outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and
      secondary (revocation rates, jail days served, prison days sentenced).
The Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration
      Field Experiment (the HOPE DFE Evaluation) has four goals: (1) Design and implement a
      randomization process in each of the four DFE sites; (2) Conduct a comprehensive process
      evaluation to assess implementation fidelity and identify lessons learned that will enhance
      future replications; (3) Conduct a rigorous experimental outcome evaluation to determine the
      effect of the HOPE model and its components on individual probation outcomes; and (4) Conduct
      a cost evaluation to assess the cost effectiveness of HOPE. The RCT will involve identifying
      in each of four sites a pool of HOPE-eligible probationers who will be randomly assigned to
      HOPE or to probation as usual (PAU). The evaluation will randomly assign approximately 400
      eligible probationers to HOPE or PAU in each of the four sites for a total sample size of
      1,600 (800 HOPE and 800 PAU). Criteria identifying the HOPE-eligible target population and
      procedures to identify that population in a timely fashion randomly assigning HOPE-eligible
      Probationers to HOPE or PAU have been identified. Random assignment will be accomplished
      using evaluation-provided forms that include study identification numbers and the random
      assignment that is covered by a scratch-off label. The assignment will be revealed only after
      the individual has been provided the opportunity to participate in the evaluation and, with
      consent, completed the baseline interview. The process evaluation/fidelity assessment
      component will document the extent to which each program conforms to the HOPE model; document
      the barriers, challenges, facilitators, and lessons learned during implementation to fill
      gaps in the knowledge base as to what is required to set up a HOPE program; and provide
      evidence as to the generalizability and sustainability of HOPE programs. This component will
      also document the PAU control conditions in each site and will assess implementation fidelity
      of evidence-based drug treatment programs. Implementation and process measures will be
      collected through stakeholder interviews; observation of initial warning hearings and court
      appearances; and review of court, probation, and HOPE project records. The process evaluation
      will also document the PAU practices to identify intervention differences among the control
      groups and to provide an opportunity to measure changes in practices that could signal
      contamination of the control arm. Fidelity assessments of drug treatment programs will be
      conducted using the Correctional Program Checklist. The outcome study will assess whether
      HOPE participation improves appointment compliance, drug test results, rearrest rates,
      revocation rates, jail days served, and prison days sentenced. In addition, the evaluation
      will determine whether HOPE participation changes potential mediators including criminal
      thinking/attitudes, perceptions of control and justice system fairness and legitimacy,
      dynamic recidivism risk factors, and employment and housing stability. For the outcome study,
      administrative data will provide information on appointment compliance, drug test results,
      re-arrests, violations, revocations, and jail and prison days for all HOPE and PAU evaluation
      participants. Interview data will be collected from evaluation participants at evaluation
      enrollment and 6 months post-enrollment on measures that will facilitate understanding of the
      nature of individual change associated with HOPE participation. All HOPE-eligible
      Probationers who consent to study participation will complete an audio computer assisted self
      interview (ACASI) at baseline and 6 months post baseline; a random sample of those completing
      ACASI baseline interviews will be asked to participate in a twice-weekly series of
      mini-interviews (telephone-ACASI or T-ACASI). Non-incarcerated individuals are being offered
      $20 equivalent to complete the ACASI interview. Random drug tests on a subsample of HOPE and
      PAU evaluation participants will be conducted in conjunction with the 6-month post-enrollment
      interviews to provide a common measure of current drug use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Illegal drug use
time frame: 6 months
description: Multiple measures to include percent positive for (1) marijuana, (2) cocaine, (3) heroin, (4) methamphetamine, and (5) any illegal drug on an oral swab drug test administered in conjunction with the 6 month follow-up interview (subjects in the community, i.e. not jailed or institutionalized, only).
measure: Rearrest
time frame: 6 Months
description: Multiple measures to include (1) percent arrested within 6 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 6 months of baseline; and (5) percent arrested for (a) violent, and (b) property
measure: Rearrest
time frame: 12 months
description: Multiple measures to include (1) percent arrested within 12 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 12 months of baseline; and (5) percent arrested for (a) violent, (b) property, and (c) drug offenses within 12 months of baseline.
measure: Probation Appointment Compliance
time frame: 6 months
description: Number of missed appointments following baseline.
measure: Probation Appointment Compliance
time frame: 12 months
description: Number of missed appointments following baseline.
measure: Probation revocation
time frame: 6 months
description: Percent revoked from probation within 6 months following baseline.
measure: jail days served
time frame: 6 months
description: Number of days served in jail within 6 months following baseline for (1) violation of conditions of probation; (2) arrest or charge for new offense; (3) sentence for new offense; and (4) total number of days.
measure: Probation Revocation
time frame: 12 Months
description: Percent revoked from probation within 12 months following baseline.
measure: Jail Days Served
time frame: 12 months
description: Number of days served in jail within 12 months following baseline for (1) violation of conditions of probation; (2) arrest or charge for new offense; (3) sentence for new offense; and (4) total number of days.
measure: Prison Days Sentenced
time frame: 6 months
description: Number of days sentenced to prison within 6 months following baseline for (1) probation revocation; (2) conviction for a new offense; and (3) total of revocation and new conviction.
measure: Prison Days Sentenced
time frame: 12 months
description: Number of days sentenced to prison within 12 months following baseline for (1) probation revocation; (2) conviction for a new offense; and (3) total of revocation and new conviction.
arm group label: HOPE
arm group type: Experimental
description: Participation in HOPE program
arm group label: Probation as Usual
arm group type: Active Comparator
description: Participation in probation as usual
intervention type: Behavioral
intervention name: HOPE
description: HOPE Court Judge provides warning hearing; random drug testing; violation hearing and jail/other sanctions for failed drug test or failure to comply with other probation conditions.
arm group label: HOPE
intervention type: Behavioral
intervention name: Probation as Usual
description: Probation officer supervises following standard protocols.
arm group label: Probation as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela K Lattimore, PhD
role: Principal Investigator
affiliation: RTI International
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders