<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/NCT04499079</url>
  </required_header>
  <id_info>
    <org_study_id>1910282231</org_study_id>
    <secondary_id>UG1DA050070</secondary_id>
    <nct_id>NCT04499079</nct_id>
  </id_info>
  <brief_title>Alliances to Disseminate Addiction Prevention and Treatment (ADAPT)</brief_title>
  <acronym>ADAPT</acronym>
  <official_title>Alliances to Disseminate Addiction Prevention and Treatment (ADAPT): A Statewide Learning Health System to Reduce Substance Use Among Justice-Involved Youth in Rural Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Youth involved in the juvenile justice system (YJJ) bear a disproportionate burden of the&#xD;
      addiction crisis. YJJ substance use (SU) is extremely prevalent, with a third of YJJ meeting&#xD;
      criteria for a substance use disorder (SUD). The investigators seek to address the national&#xD;
      addiction crisis at its epicenter.&#xD;
&#xD;
      Despite their high need for SUD services, and the proliferation of evidence-based&#xD;
      interventions to reduce SU, YJJ are rarely connected to needed, high-quality SU care. A care&#xD;
      cascade model highlights gaps in YJJ achieving the full continuum of SUD care (i.e., SUD risk&#xD;
      identification, treatment referral, treatment initiation, and treatment engagement). YJJ on&#xD;
      community supervision/probation face a unique problem accessing SUD services; while the&#xD;
      courts or probation may identify YJJ need for SUD care, YJJ must receive care through&#xD;
      healthcare agencies in the community. The primary goal of the project, Alliances to&#xD;
      Disseminate Addiction Prevention and Treatment (ADAPT) is to address this and other gaps&#xD;
      along the care cascade for YJJ. The investigators will accomplish this goal by creating&#xD;
      alliances between the juvenile justice system (JJ) agencies and community mental health&#xD;
      centers (CMHCs) in eight Indiana counties.&#xD;
&#xD;
      ADAPT takes a two-pronged approach. First, the investigators will employ a Learning Health&#xD;
      System (LHS) to develop collaborative alliances between JJ agencies and CMHCs, organizations&#xD;
      that traditionally operate independently. Second, the investigators will present local&#xD;
      Cascade data during continuous quality improvement cycles within the LHS alliances. By&#xD;
      offering agency representatives an opportunity to view and discuss, for example, the local&#xD;
      rate at which YJJ with SUD risk are initiating CMHC SU services, the investigators will&#xD;
      facilitate development of tailored, local solutions to improve the Cascade for each county's&#xD;
      YJJ.&#xD;
&#xD;
      To maximize long-term sustainability of ADAPT's JJ-CMHC alliances, the investigators will&#xD;
      conduct this research in collaboration with leaders from an existing statewide initiative,&#xD;
      the Juvenile Detention Alternatives Initiative (JDAI). JDAI is a juvenile justice reform&#xD;
      effort that utilizes data-driven decision-making and is implemented in almost 300 counties&#xD;
      across the US. If this project is successful, the JDAI infrastructure and support for this&#xD;
      research will inform sustainment and expansion across Indiana and the nation.&#xD;
&#xD;
      The investigators hypothesize that ADAPT - novel LHS alliances using Cascade data to&#xD;
      implement localized solutions to YJJ receiving evidence-based addictions care - will&#xD;
      positively impact SU and recidivism outcomes over time. The investigators seek to complete&#xD;
      the following specific aims:&#xD;
&#xD;
      AIM 1: Implement LHS alliances between JJ agencies and CMHCs. The investigators will&#xD;
      establish LHS alliances: novel, collaborative partnerships between JJ agencies and CMHCs.&#xD;
&#xD;
      AIM 2: Generate and track local solutions to address gaps in the Cascade for YJJ in rural&#xD;
      Indiana counties. Quantifying local Cascade data will enable JJ agencies and CMHCs to suggest&#xD;
      and implement tailored, evidenced-based interventions, which will be tracked through LHS&#xD;
      quality improvement cycles.&#xD;
&#xD;
      AIM 3: Assess implementation outcomes and processes. We will assess implementation outcomes,&#xD;
      such as system alliance, among JJ and CHMC personnel using mixed methods.&#xD;
&#xD;
      AIM 4: Assess the impact of ADAPT. Conduct a stepped wedge cluster randomized controlled&#xD;
      trial to assess the impact of LHS alliances on the Cascade for YJJ. We will analyze&#xD;
      administrative data linked across JJ and health systems to assess the long-term,&#xD;
      community-wide effects of ADAPT on public health and safety outcomes (e.g., lower rates of&#xD;
      SU-related outcomes and criminal recidivism).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</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>Utilization of substance use treatment services</measure>
    <time_frame>10 years</time_frame>
    <description>Completion of substance use treatment, completion of substance use classes, enrollment in medication assisted treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recidivism</measure>
    <time_frame>10 years</time_frame>
    <description>Rate of re-offense</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Substance use related health outcomes</measure>
    <time_frame>10 years</time_frame>
    <description>Hospital and emergency department visits related to substance use</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12400</enrollment>
  <condition>Substance-Related Disorders</condition>
  <condition>Recidivism</condition>
  <condition>Opioid-Related Disorders</condition>
  <condition>Substance Use</condition>
  <condition>Criminal Behavior</condition>
  <arm_group>
    <arm_group_label>Probation Referral Practice as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Data are collected regarding standard probation practice and outcomes before implementation of the Learning Health System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Learning Health System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participating counties receive a system-level intervention, a Learning Health System, designed to improve youth connection to substance use treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Learning Health System</intervention_name>
    <description>This is a system-level intervention designed to improve collaboration among personnel from the juvenile and behavioral healthcare systems.</description>
    <arm_group_label>Learning Health System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Youth Inclusion Criteria:&#xD;
&#xD;
          -  Reside in a participating county assigned to receive the LHS intervention&#xD;
&#xD;
          -  Utilized any local CMHC service during the 24-month intervention period&#xD;
&#xD;
          -  Age 11 to 22 years old&#xD;
&#xD;
        Youth Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Matthew Aalsma</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Juvenile Justice Behavioral Health Services Cascade</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Opioid-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/NCT04499079
org study id: 1910282231
secondary id: UG1DA050070
nct id: NCT04499079
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Youth involved in the juvenile justice system (YJJ) bear a disproportionate burden of the
      addiction crisis. YJJ substance use (SU) is extremely prevalent, with a third of YJJ meeting
      criteria for a substance use disorder (SUD). The investigators seek to address the national
      addiction crisis at its epicenter.

      Despite their high need for SUD services, and the proliferation of evidence-based
      interventions to reduce SU, YJJ are rarely connected to needed, high-quality SU care. A care
      cascade model highlights gaps in YJJ achieving the full continuum of SUD care (i.e., SUD risk
      identification, treatment referral, treatment initiation, and treatment engagement). YJJ on
      community supervision/probation face a unique problem accessing SUD services; while the
      courts or probation may identify YJJ need for SUD care, YJJ must receive care through
      healthcare agencies in the community. The primary goal of the project, Alliances to
      Disseminate Addiction Prevention and Treatment (ADAPT) is to address this and other gaps
      along the care cascade for YJJ. The investigators will accomplish this goal by creating
      alliances between the juvenile justice system (JJ) agencies and community mental health
      centers (CMHCs) in eight Indiana counties.

      ADAPT takes a two-pronged approach. First, the investigators will employ a Learning Health
      System (LHS) to develop collaborative alliances between JJ agencies and CMHCs, organizations
      that traditionally operate independently. Second, the investigators will present local
      Cascade data during continuous quality improvement cycles within the LHS alliances. By
      offering agency representatives an opportunity to view and discuss, for example, the local
      rate at which YJJ with SUD risk are initiating CMHC SU services, the investigators will
      facilitate development of tailored, local solutions to improve the Cascade for each county's
      YJJ.

      To maximize long-term sustainability of ADAPT's JJ-CMHC alliances, the investigators will
      conduct this research in collaboration with leaders from an existing statewide initiative,
      the Juvenile Detention Alternatives Initiative (JDAI). JDAI is a juvenile justice reform
      effort that utilizes data-driven decision-making and is implemented in almost 300 counties
      across the US. If this project is successful, the JDAI infrastructure and support for this
      research will inform sustainment and expansion across Indiana and the nation.

      The investigators hypothesize that ADAPT - novel LHS alliances using Cascade data to
      implement localized solutions to YJJ receiving evidence-based addictions care - will
      positively impact SU and recidivism outcomes over time. The investigators seek to complete
      the following specific aims:

      AIM 1: Implement LHS alliances between JJ agencies and CMHCs. The investigators will
      establish LHS alliances: novel, collaborative partnerships between JJ agencies and CMHCs.

      AIM 2: Generate and track local solutions to address gaps in the Cascade for YJJ in rural
      Indiana counties. Quantifying local Cascade data will enable JJ agencies and CMHCs to suggest
      and implement tailored, evidenced-based interventions, which will be tracked through LHS
      quality improvement cycles.

      AIM 3: Assess implementation outcomes and processes. We will assess implementation outcomes,
      such as system alliance, among JJ and CHMC personnel using mixed methods.

      AIM 4: Assess the impact of ADAPT. Conduct a stepped wedge cluster randomized controlled
      trial to assess the impact of LHS alliances on the Cascade for YJJ. We will analyze
      administrative data linked across JJ and health systems to assess the long-term,
      community-wide effects of ADAPT on public health and safety outcomes (e.g., lower rates of
      SU-related outcomes and criminal recidivism).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Utilization of substance use treatment services
time frame: 10 years
description: Completion of substance use treatment, completion of substance use classes, enrollment in medication assisted treatment
measure: Recidivism
time frame: 10 years
description: Rate of re-offense
measure: Substance use related health outcomes
time frame: 10 years
description: Hospital and emergency department visits related to substance use
arm group label: Probation Referral Practice as Usual
arm group type: No Intervention
description: Data are collected regarding standard probation practice and outcomes before implementation of the Learning Health System.
arm group label: Learning Health System
arm group type: Experimental
description: Participating counties receive a system-level intervention, a Learning Health System, designed to improve youth connection to substance use treatment.
intervention type: Other
intervention name: Learning Health System
description: This is a system-level intervention designed to improve collaboration among personnel from the juvenile and behavioral healthcare systems.
arm group label: Learning Health System
criteria: 
gender: All
minimum age: 11 Years
maximum age: 22 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Matthew Aalsma
investigator title: Professor of Pediatrics
mesh term: Substance-Related Disorders
mesh term: Opioid-Related Disorders
sharing ipd: No