xml: <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/NCT06003725</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00122199</org_study_id>
      <nct_id>NCT06003725</nct_id>
    </id_info>
    <brief_title>Cultural Adaptation of Drug Treatment for DJJ Youth</brief_title>
    <official_title>The Cultural Adaptation of an Alcohol and Other Drug Use Treatment for Black Justice Involved Youth</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of South Carolina</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 project aims to improve the understanding of the impact of Ethnic and Racial&#xD;
        Discrimination (ERD) on adolescent alcohol and other drug use (AOD) within the Black&#xD;
        Justice-Involved Youth (JIY) population. Individual interviews with Black JIY and focus&#xD;
        groups with parents and guardians of Black JIY and community members who support change and&#xD;
        reform in the justice community for Black JIY will be conducted.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Black JIY are overrepresented in the criminal justice system due to institutional racism and&#xD;
        discrimination. The General Strain Theory posits that high levels of ethnic and racial&#xD;
        discrimination (ERD), paired with elevated levels of witnessing or experiencing police&#xD;
        brutality, places Black JIY at unique risk of increased alcohol and other drug use (AOD) as a&#xD;
        means of coping with stressful events. Black JIY report engaging in comorbid alcohol and&#xD;
        cannabis use to achieve temporary respite from discrimination-induced stress. While JIY&#xD;
        engage in higher rates of comorbid alcohol and cannabis use compared to non-justice-involved&#xD;
        youth, overall, Black JIY are less likely to be diverted to substance use treatment programs,&#xD;
        less likely to engage in care after being released on probation, less likely to benefit from&#xD;
        substance use treatment in terms of reduced risk of recidivism, and are more adversely&#xD;
        affected by early onset of AOD activity than White JIY. To date, no known adolescent&#xD;
        substance use treatment directly addresses ERD, the increased risk of AOD due to ERD, or&#xD;
        explicitly presents tools on how to appropriately respond to AOD and discrimination distress&#xD;
        among Black JIY. To address this problem, the investigator's research program aspires to&#xD;
        improve the understanding of the impact of ERD on adolescent AOD within the Black JIY&#xD;
        population. Individual interviews with Black JIY and focus groups with guardians of Black JIY&#xD;
        and community members will be conducted. Data will be used to culturally adapt an adolescent&#xD;
        substance use intervention. The culturally adapted intervention will then be piloted with 30&#xD;
        Black JIY.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 30, 2022</start_date>
    <completion_date type="Anticipated">May 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Individual interviews with Black justice-involved youth (JIY) and focus groups with guardians of Black JIY and community members will be conducted. Data from focus groups and interviews will be used to inform the cultural adaptation of an evidence-based adolescent substance use treatment. The cultural adapted treatment will then be piloted with 30 Black JIY for feasibility and acceptability.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility and Acceptability</measure>
      <time_frame>After study completion, an average of 3 months</time_frame>
      <description>Participants will complete feasibility and acceptability questionnaires and provide qualitative data on likes and dislikes about the intervention, delivery, session structure, and content.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in substance use</measure>
      <time_frame>Baseline, after each study visit, at study completion, up to 3 months post-intervention, an average of 6 months.</time_frame>
      <description>Participants will complete urinalysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in substance use</measure>
      <time_frame>Baseline, after each study visit, at study completion, up to 3 months post-intervention, an average of 6 months.</time_frame>
      <description>Participants will complete timeline followback</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in discrimination distress</measure>
      <time_frame>baseline, after study completion, and up to 3 months post-intervention, an average of 6 months.</time_frame>
      <description>Participants will complete a discrimination distress assessment measure</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Substance Use</condition>
    <arm_group>
      <arm_group_label>ADAP-ITT Phase 8</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phase 8 consists of piloting the culturally adapted CYT intervention with 30 Black JIY to examine feasibility and acceptability.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Culturally Adapted Adolescent Substance Use Treatment</intervention_name>
      <description>The Cannabis Youth Treatment Series (CYT) (MET/CBT12 model) aims to reduce alcohol and cannabis use.</description>
      <arm_group_label>ADAP-ITT Phase 8</arm_group_label>
      <other_name>Cannabis Youth Treatment Series</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          For Focus Groups and Interviews:&#xD;
  &#xD;
          Black JIY Participants:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
          • Between the ages of 12-17, 2) identify as Black or African American, and 3) on community&#xD;
          probation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Will be excluded if they do not have parental consent to participate.&#xD;
  &#xD;
          For Focus Groups and Interviews:&#xD;
  &#xD;
          Adult Participants&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  A guardian of JIY&#xD;
  &#xD;
            -  An advocate (someone who supports change and reform in the justice community) for&#xD;
               Black JIY.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Will be excluded if they do not provide consent to participate.&#xD;
  &#xD;
          For pilot feasibility study:&#xD;
  &#xD;
          Black JIY Participants:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 12 and 17&#xD;
  &#xD;
            -  Identify as Black or African American&#xD;
  &#xD;
            -  Be on community probation&#xD;
  &#xD;
            -  Meet criteria for alcohol, cannabis, or other drug misuse as defined by the DSM 5&#xD;
  &#xD;
            -  Be experiencing at least 1 problem related to AOD;&#xD;
  &#xD;
            -  The frequency of AOD must be weekly use over a 3-month period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Will be excluded if they do not have parental consent to participate&#xD;
  &#xD;
            -  Parole violation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brittany E Bryant, DSW</last_name>
      <phone>843-973-0867</phone>
      <email>goldsmib@musc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical University of South Carolina</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29425</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brittany Bryant, DSW</last_name>
        <phone>843-973-0867</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Brittany Bryant</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Substance use</keyword>
    <keyword>substance misuse</keyword>
    <keyword>adolescent</keyword>
    <keyword>cultural adaptation</keyword>
    <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>
      <ipd_description>IPD will not be shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003725
  org study id: Pro00122199
  nct id: NCT06003725
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project aims to improve the understanding of the impact of Ethnic and Racial
        Discrimination (ERD) on adolescent alcohol and other drug use (AOD) within the Black
        Justice-Involved Youth (JIY) population. Individual interviews with Black JIY and focus
        groups with parents and guardians of Black JIY and community members who support change and
        reform in the justice community for Black JIY will be conducted.
  Black JIY are overrepresented in the criminal justice system due to institutional racism and
        discrimination. The General Strain Theory posits that high levels of ethnic and racial
        discrimination (ERD), paired with elevated levels of witnessing or experiencing police
        brutality, places Black JIY at unique risk of increased alcohol and other drug use (AOD) as a
        means of coping with stressful events. Black JIY report engaging in comorbid alcohol and
        cannabis use to achieve temporary respite from discrimination-induced stress. While JIY
        engage in higher rates of comorbid alcohol and cannabis use compared to non-justice-involved
        youth, overall, Black JIY are less likely to be diverted to substance use treatment programs,
        less likely to engage in care after being released on probation, less likely to benefit from
        substance use treatment in terms of reduced risk of recidivism, and are more adversely
        affected by early onset of AOD activity than White JIY. To date, no known adolescent
        substance use treatment directly addresses ERD, the increased risk of AOD due to ERD, or
        explicitly presents tools on how to appropriately respond to AOD and discrimination distress
        among Black JIY. To address this problem, the investigator's research program aspires to
        improve the understanding of the impact of ERD on adolescent AOD within the Black JIY
        population. Individual interviews with Black JIY and focus groups with guardians of Black JIY
        and community members will be conducted. Data will be used to culturally adapt an adolescent
        substance use intervention. The culturally adapted intervention will then be piloted with 30
        Black JIY.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: Individual interviews with Black justice-involved youth (JIY) and focus groups with guardians of Black JIY and community members will be conducted. Data from focus groups and interviews will be used to inform the cultural adaptation of an evidence-based adolescent substance use treatment. The cultural adapted treatment will then be piloted with 30 Black JIY for feasibility and acceptability.
  primary purpose: Other
  masking: None (Open Label)
  masking description: No masking
  measure: Feasibility and Acceptability
  time frame: After study completion, an average of 3 months
  description: Participants will complete feasibility and acceptability questionnaires and provide qualitative data on likes and dislikes about the intervention, delivery, session structure, and content.
  measure: Change in substance use
  time frame: Baseline, after each study visit, at study completion, up to 3 months post-intervention, an average of 6 months.
  description: Participants will complete urinalysis
  measure: Change in substance use
  time frame: Baseline, after each study visit, at study completion, up to 3 months post-intervention, an average of 6 months.
  description: Participants will complete timeline followback
  measure: Change in discrimination distress
  time frame: baseline, after study completion, and up to 3 months post-intervention, an average of 6 months.
  description: Participants will complete a discrimination distress assessment measure
  arm group label: ADAP-ITT Phase 8
  arm group type: Experimental
  description: Phase 8 consists of piloting the culturally adapted CYT intervention with 30 Black JIY to examine feasibility and acceptability.
  intervention type: Behavioral
  intervention name: Culturally Adapted Adolescent Substance Use Treatment
  description: The Cannabis Youth Treatment Series (CYT) (MET/CBT12 model) aims to reduce alcohol and cannabis use.
  arm group label: ADAP-ITT Phase 8
  other name: Cannabis Youth Treatment Series
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Brittany E Bryant, DSW
  phone: 843-973-0867
  email: goldsmib@musc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Brittany Bryant
  investigator title: Assistant Professor
  mesh term: Substance-Related Disorders
  sharing ipd: No
  ipd description: IPD will not be shared.