<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/NCT03804242</url>
  </required_header>
  <id_info>
    <org_study_id>APP-18-07635</org_study_id>
    <nct_id>NCT03804242</nct_id>
  </id_info>
  <brief_title>Black Youth M.A.T.T.E.R: Positive Youth Development Group Intervention</brief_title>
  <acronym>BYM</acronym>
  <official_title>A Randomized Controlled Trial of a Positive Youth Development Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Los Angeles</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>
      One in three Black boys born today in the United States will be incarcerated at some point in&#xD;
      their lifetime, compared to one in 17 White boys. Black males are more likely to be arrested,&#xD;
      convicted, and given unfair sentences. Black youth comprise of 16% of the Nation's public&#xD;
      schools, but account for 32% of suspended students. For over 30 years, research has&#xD;
      consistently highlighted the disproportionately severe disciplinary practices used with Black&#xD;
      male students.Consistent research demonstrates that students who are suspended or expelled&#xD;
      tend to drop out of school and/or become incarcerated in a juvenile detention center. Black&#xD;
      students may relate their racial-ethnic identity, such as their understanding of their race&#xD;
      and ethnicity, to academic success. Moreover, their attitudes may result from the expectation&#xD;
      of their teachers. It is imperative that advocates devoted to positive youth development&#xD;
      intervene to this issue negatively affecting the well-being of Black youth. Under the&#xD;
      mentorship of Caitlin Sayegh, Ph.D., postdoctoral fellow Tierra Ellis, Ph.D., has developed a&#xD;
      9-session group intervention called Black Youth M.A.T.T.E.R. (BYM), which aims to debunk&#xD;
      mental health stigma, help children shift their cognitive distortions about education, and&#xD;
      normalize their experiences through group activities, while introducing them to advocacy and&#xD;
      self-empowerment. This intervention may decrease mental health symptoms, increase motivation&#xD;
      to approach goal-oriented outcomes, and reverse internalized beliefs and attitudes which may&#xD;
      foster more positive perceptions related to school.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a randomized control trial mixed-methods pilot study of BYM. We aim to&#xD;
      finalize the intervention protocol, assess feasibility and acceptability of the intervention,&#xD;
      and evaluate the potential impact of BYM on pilot participants. The mixed-methods research&#xD;
      design approach will be used within a single study for the collection, analyzing, and merging&#xD;
      of qualitative and quantitative data. The purpose of a convergent parallel mixed methods&#xD;
      research design is to simultaneously collect qualitative and quantitative data for a more&#xD;
      comprehensive analysis.&#xD;
&#xD;
      Research Questions: (1) What do Black adolescents and other community stakeholders perceive&#xD;
      as the most effective approaches for the BYM project? (2) What are BYM participants'&#xD;
      perceptions of the intervention? (3) Is there a decrease in mental health symptoms (e.g.,&#xD;
      depression, anxiety, trauma) for BYM participants? (3) Is there an increase in resiliency for&#xD;
      BYM participants? (4) Is there an increase in positive attitudes toward seeking mental health&#xD;
      treatment for BYM participants? (5) Is there a difference in motivation to approach&#xD;
      goal-oriented outcomes for BYM participants? (6) Is there an increase in perceived positive&#xD;
      self-concept for BYM participants? (7) Is there a decrease in risk behaviors for BYM&#xD;
      participants? Intervention Description: The session topics are as follows: (1) Debunking the&#xD;
      Stigma of Mental Health in the Black Community, (2) School to Prison Pipeline, (3)&#xD;
      Achievement Gap, (4) Cultural Barrier that Black Students Experience with Teachers, (5)&#xD;
      Trauma 101, (6) Trauma 102, (7) Actions of Today, Blueprints for Tomorrow: Youth Organizing&#xD;
      to Transform Education film, (8) My Voice Will Be Heard (Part I), and (9) My Voice Will Be&#xD;
      Heard (Part II). The intervention will be conducted in 2-hour weekly group sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 2019</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Randomized controlled pilot trial of intervention versus usual care</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants, school staff, researchers, and outcome assessor will all be aware of condition assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depressive symptoms and anxiety symptoms</measure>
    <time_frame>61 weeks</time_frame>
    <description>Revised Children's Anxiety and Depression Scale. The T-score related to Total Anxiety and Depression score will be examined (ranging from 26 to &gt;80). Higher scores indicate increased depression and anxiety symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in trauma symptoms</measure>
    <time_frame>61 weeks</time_frame>
    <description>Trauma Symptom Checklist for Children: Examining Posttraumatic Stress T-score (ranging from 26 to &gt;80), where higher scores indicated greater PTSD symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Youth Reporting Substance Use</measure>
    <time_frame>61 weeks</time_frame>
    <description>Youth Risk Behavior Survey. We will examine dichotomous use of tobacco, alcohol, cannabis, and other drugs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Resiliency</measure>
    <time_frame>61 weeks</time_frame>
    <description>Resiliency Scale; range from 0 to 14 with higher scores representing more resiliency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Levels of Help-Seeking</measure>
    <time_frame>61 weeks</time_frame>
    <description>Attitudes Toward Seeking Professional Help; scores range from 0 to 30 with higher scores indicated more positive views of help-seeking</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Black Youth M.A.T.T.E.R.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The session topics are as follows: (1) Debunking the Stigma of Mental Health in the Black Community, (2) School to Prison Pipeline, (3) Achievement Gap, (4) Cultural Barrier that Black Students Experience with Teachers, (5) Trauma 101, (6) Trauma 102, (7) Actions of Today, Blueprints for Tomorrow: Youth Organizing to Transform Education film, (8) My Voice Will Be Heard (Part I), and (9) My Voice Will Be Heard (Part II). The intervention will be conducted in 2-hour weekly group sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants already participate in Youth Justice Coalition's Free LA High School. Those in control condition will participate in educational activities as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience</intervention_name>
    <description>This is a group psychoeducational and positive youth development intervention for students who have been expelled from school and are now enrolled in a specialized school at Youth Justice Coalition.</description>
    <arm_group_label>Black Youth M.A.T.T.E.R.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Black adolescents attending Youth Justice Coalition Free LA High School who have been&#xD;
             suspended or expelled from their respective schools due to behavioral problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active psychosis or suicidal ideation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Caitlin S Sayegh, Ph.D.</last_name>
    <phone>323-361-7748</phone>
    <email>cssayegh@chla.usc.edu</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
    <investigator_full_name>Caitlin Sayegh</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical Pediatrics</investigator_title>
  </responsible_party>
  <keyword>positive youth development</keyword>
  <keyword>school-to-prison pipeline</keyword>
  <keyword>mental health stigma</keyword>
  <keyword>help-seeking</keyword>
  <keyword>identity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT03804242
org study id: APP-18-07635
nct id: NCT03804242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One in three Black boys born today in the United States will be incarcerated at some point in
      their lifetime, compared to one in 17 White boys. Black males are more likely to be arrested,
      convicted, and given unfair sentences. Black youth comprise of 16% of the Nation's public
      schools, but account for 32% of suspended students. For over 30 years, research has
      consistently highlighted the disproportionately severe disciplinary practices used with Black
      male students.Consistent research demonstrates that students who are suspended or expelled
      tend to drop out of school and/or become incarcerated in a juvenile detention center. Black
      students may relate their racial-ethnic identity, such as their understanding of their race
      and ethnicity, to academic success. Moreover, their attitudes may result from the expectation
      of their teachers. It is imperative that advocates devoted to positive youth development
      intervene to this issue negatively affecting the well-being of Black youth. Under the
      mentorship of Caitlin Sayegh, Ph.D., postdoctoral fellow Tierra Ellis, Ph.D., has developed a
      9-session group intervention called Black Youth M.A.T.T.E.R. (BYM), which aims to debunk
      mental health stigma, help children shift their cognitive distortions about education, and
      normalize their experiences through group activities, while introducing them to advocacy and
      self-empowerment. This intervention may decrease mental health symptoms, increase motivation
      to approach goal-oriented outcomes, and reverse internalized beliefs and attitudes which may
      foster more positive perceptions related to school.
The proposed study is a randomized control trial mixed-methods pilot study of BYM. We aim to
      finalize the intervention protocol, assess feasibility and acceptability of the intervention,
      and evaluate the potential impact of BYM on pilot participants. The mixed-methods research
      design approach will be used within a single study for the collection, analyzing, and merging
      of qualitative and quantitative data. The purpose of a convergent parallel mixed methods
      research design is to simultaneously collect qualitative and quantitative data for a more
      comprehensive analysis.

      Research Questions: (1) What do Black adolescents and other community stakeholders perceive
      as the most effective approaches for the BYM project? (2) What are BYM participants'
      perceptions of the intervention? (3) Is there a decrease in mental health symptoms (e.g.,
      depression, anxiety, trauma) for BYM participants? (3) Is there an increase in resiliency for
      BYM participants? (4) Is there an increase in positive attitudes toward seeking mental health
      treatment for BYM participants? (5) Is there a difference in motivation to approach
      goal-oriented outcomes for BYM participants? (6) Is there an increase in perceived positive
      self-concept for BYM participants? (7) Is there a decrease in risk behaviors for BYM
      participants? Intervention Description: The session topics are as follows: (1) Debunking the
      Stigma of Mental Health in the Black Community, (2) School to Prison Pipeline, (3)
      Achievement Gap, (4) Cultural Barrier that Black Students Experience with Teachers, (5)
      Trauma 101, (6) Trauma 102, (7) Actions of Today, Blueprints for Tomorrow: Youth Organizing
      to Transform Education film, (8) My Voice Will Be Heard (Part I), and (9) My Voice Will Be
      Heard (Part II). The intervention will be conducted in 2-hour weekly group sessions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled pilot trial of intervention versus usual care
primary purpose: Prevention
masking: None (Open Label)
masking description: Participants, school staff, researchers, and outcome assessor will all be aware of condition assignment
measure: Change in depressive symptoms and anxiety symptoms
time frame: 61 weeks
description: Revised Children's Anxiety and Depression Scale. The T-score related to Total Anxiety and Depression score will be examined (ranging from 26 to >80). Higher scores indicate increased depression and anxiety symptoms.
measure: Change in trauma symptoms
time frame: 61 weeks
description: Trauma Symptom Checklist for Children: Examining Posttraumatic Stress T-score (ranging from 26 to >80), where higher scores indicated greater PTSD symptoms.
measure: Change in Youth Reporting Substance Use
time frame: 61 weeks
description: Youth Risk Behavior Survey. We will examine dichotomous use of tobacco, alcohol, cannabis, and other drugs
measure: Change in Resiliency
time frame: 61 weeks
description: Resiliency Scale; range from 0 to 14 with higher scores representing more resiliency
measure: Change in Levels of Help-Seeking
time frame: 61 weeks
description: Attitudes Toward Seeking Professional Help; scores range from 0 to 30 with higher scores indicated more positive views of help-seeking
arm group label: Black Youth M.A.T.T.E.R.
arm group type: Experimental
description: The session topics are as follows: (1) Debunking the Stigma of Mental Health in the Black Community, (2) School to Prison Pipeline, (3) Achievement Gap, (4) Cultural Barrier that Black Students Experience with Teachers, (5) Trauma 101, (6) Trauma 102, (7) Actions of Today, Blueprints for Tomorrow: Youth Organizing to Transform Education film, (8) My Voice Will Be Heard (Part I), and (9) My Voice Will Be Heard (Part II). The intervention will be conducted in 2-hour weekly group sessions.
arm group label: Usual Care
arm group type: No Intervention
description: All participants already participate in Youth Justice Coalition's Free LA High School. Those in control condition will participate in educational activities as usual.
intervention type: Behavioral
intervention name: Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience
description: This is a group psychoeducational and positive youth development intervention for students who have been expelled from school and are now enrolled in a specialized school at Youth Justice Coalition.
arm group label: Black Youth M.A.T.T.E.R.
criteria: 
gender: All
minimum age: 15 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Caitlin S Sayegh, Ph.D.
phone: 323-361-7748
email: cssayegh@chla.usc.edu
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Los Angeles
investigator full name: Caitlin Sayegh
investigator title: Assistant Professor of Clinical Pediatrics
mesh term: Depression
sharing ipd: No