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/NCT05974176</url>
    </required_header>
    <id_info>
      <org_study_id>23-00094</org_study_id>
      <nct_id>NCT05974176</nct_id>
    </id_info>
    <brief_title>Considering Racial and Acculturation Stress in Addressing Trauma</brief_title>
    <official_title>Evaluating the Effectiveness of Evidence-based Trauma Interventions (Trauma Focused CBT - TF-CBT; and Trauma Systems Therapy - TST), Baseline Index Trauma, and PTSD Symptoms in the Context of Contributing Stress From Racialized Trauma and Acculturation Stress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Substance Abuse and Mental Health Services Administration (SAMHSA)</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>NYU Langone Health</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>
        Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive&#xD;
        Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children&#xD;
        and their families. The investigators are looking to evaluate the effectiveness of these&#xD;
        interventions in the context of additional stress related to racialized trauma and&#xD;
        acculturation stress&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2027</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>Child and Adolescent Trauma Screen (CATS) Score at Baseline</measure>
      <time_frame>Baseline (Day 1)</time_frame>
      <description>CATS is a 15-item assessment of potentially traumatic events and of posttraumatic stress symptoms. The total score is the sum of responses and ranges from 0-60; higher scores indicates more symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CATS Score at Completion of Intervention</measure>
      <time_frame>Completion of Intervention (Typically Month 3-4)</time_frame>
      <description>CATS is a 15-item assessment of potentially traumatic events and of posttraumatic stress symptoms. The total score is the sum of responses and ranges from 0-60; higher scores indicates more symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acculturative Stress Scale (SAFE) Score at Baseline</measure>
      <time_frame>Baseline (Day 1)</time_frame>
      <description>SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SAFE Score at Completion of Intervention</measure>
      <time_frame>Completion of Intervention (Typically Month 3-4)</time_frame>
      <description>SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bidimensional Acculturation Scale (BAS) Score at Baseline</measure>
      <time_frame>Baseline (Day 1)</time_frame>
      <description>BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BAS Score at Completion of Intervention</measure>
      <time_frame>Completion of Intervention (Typically Month 3-4)</time_frame>
      <description>BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline</measure>
      <time_frame>Baseline (Day 1)</time_frame>
      <description>6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention</measure>
      <time_frame>Completion of Intervention (Typically Month 3-4)</time_frame>
      <description>6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trauma Symptoms of Discrimination Scale (TSDS) at Baseline</measure>
      <time_frame>Baseline (Day 1)</time_frame>
      <description>21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention</measure>
      <time_frame>Completion of Intervention (Typically Month 3-4)</time_frame>
      <description>21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">475</enrollment>
    <condition>Trauma-related PTSD</condition>
    <arm_group>
      <arm_group_label>Trauma Focused CBT (TF-CBT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients and families randomized to engage in TF-CBT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Trauma Systems therapy (TST)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients and families randomized to engage in TST.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Trauma Focused CBT (TF-CBT)</intervention_name>
      <description>TF-CBT is an evidence-based treatment for children and adolescents impacted by trauma and their parents or caregivers. It is a components-based treatment model that incorporates trauma-sensitive interventions with cognitive behavioral, family, and humanistic principles and techniques.</description>
      <arm_group_label>Trauma Focused CBT (TF-CBT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Trauma Systems therapy (TST)</intervention_name>
      <description>Trauma Systems Therapy (TST) is focused on the factors that contribute to children and adolescents who experience traumatic stress through the lens of the social context, vulnerabilities, and strengths of the person undergoing treatment.</description>
      <arm_group_label>Trauma Systems therapy (TST)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child/adolescent aged 5-17 years of age who has experienced trauma with associated and&#xD;
               related emotional dysregulation (i.e PTSD) and one of their parent/guardian&#xD;
  &#xD;
            -  Have capacity and willingness to provide consent or age-appropriate assent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individual with intellectual disability with an IQ&lt;70&#xD;
  &#xD;
            -  Individual with active suicidality, homicidality, or other symptoms at the time of&#xD;
               enrollment that warrants hospitalization&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aaron Reliford</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aaron Reliford</last_name>
      <phone>646-594-8895</phone>
      <email>Aaron.reliford@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yessenia Mejia</last_name>
      <email>Yessenia.mejia@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Shared only with study team.</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/NCT05974176
  org study id: 23-00094
  nct id: NCT05974176
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive
        Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children
        and their families. The investigators are looking to evaluate the effectiveness of these
        interventions in the context of additional stress related to racialized trauma and
        acculturation stress
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Child and Adolescent Trauma Screen (CATS) Score at Baseline
  time frame: Baseline (Day 1)
  description: CATS is a 15-item assessment of potentially traumatic events and of posttraumatic stress symptoms. The total score is the sum of responses and ranges from 0-60; higher scores indicates more symptoms.
  measure: CATS Score at Completion of Intervention
  time frame: Completion of Intervention (Typically Month 3-4)
  description: CATS is a 15-item assessment of potentially traumatic events and of posttraumatic stress symptoms. The total score is the sum of responses and ranges from 0-60; higher scores indicates more symptoms.
  measure: Acculturative Stress Scale (SAFE) Score at Baseline
  time frame: Baseline (Day 1)
  description: SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress.
  measure: SAFE Score at Completion of Intervention
  time frame: Completion of Intervention (Typically Month 3-4)
  description: SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress.
  measure: Bidimensional Acculturation Scale (BAS) Score at Baseline
  time frame: Baseline (Day 1)
  description: BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation.
  measure: BAS Score at Completion of Intervention
  time frame: Completion of Intervention (Typically Month 3-4)
  description: BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation.
  measure: Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline
  time frame: Baseline (Day 1)
  description: 6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify.
  measure: Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention
  time frame: Completion of Intervention (Typically Month 3-4)
  description: 6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify.
  measure: Trauma Symptoms of Discrimination Scale (TSDS) at Baseline
  time frame: Baseline (Day 1)
  description: 21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms.
  measure: Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention
  time frame: Completion of Intervention (Typically Month 3-4)
  description: 21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms.
  arm group label: Trauma Focused CBT (TF-CBT)
  arm group type: Experimental
  description: Patients and families randomized to engage in TF-CBT.
  arm group label: Trauma Systems therapy (TST)
  arm group type: Experimental
  description: Patients and families randomized to engage in TST.
  intervention type: Behavioral
  intervention name: Trauma Focused CBT (TF-CBT)
  description: TF-CBT is an evidence-based treatment for children and adolescents impacted by trauma and their parents or caregivers. It is a components-based treatment model that incorporates trauma-sensitive interventions with cognitive behavioral, family, and humanistic principles and techniques.
  arm group label: Trauma Focused CBT (TF-CBT)
  intervention type: Behavioral
  intervention name: Trauma Systems therapy (TST)
  description: Trauma Systems Therapy (TST) is focused on the factors that contribute to children and adolescents who experience traumatic stress through the lens of the social context, vulnerabilities, and strengths of the person undergoing treatment.
  arm group label: Trauma Systems therapy (TST)
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Aaron Reliford
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Aaron Reliford
  phone: 646-594-8895
  email: Aaron.reliford@nyulangone.org
  last name: Yessenia Mejia
  email: Yessenia.mejia@nyulangone.org
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Wounds and Injuries
  sharing ipd: No
  ipd description: Shared only with study team.