<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/NCT03831139</url>
  </required_header>
  <id_info>
    <org_study_id>15.0318</org_study_id>
    <nct_id>NCT03831139</nct_id>
  </id_info>
  <brief_title>Cultural Adaptation of the TIM&amp;SARA Prevention Program</brief_title>
  <official_title>What Makes Prevention Work? Cultural Adaptation of an Effective Program for African-American Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</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>
      Disparities between African-American and European-American youth regarding academic outcomes,&#xD;
      mental health, and physical health exist. Depression, a very common mental health problem,&#xD;
      plays a central role by impacting academic outcomes and cardiovascular health. Thus, a&#xD;
      program that successfully reduces the likelihood for youths to develop depression should also&#xD;
      reduce problems with academic outcomes and physical health and therefore reduce disparity in&#xD;
      all three domains. Research demonstrates that European-American youth benefit more from&#xD;
      programs preventing the development of depression than their African-American peers. Thus,&#xD;
      the goals of this project are to (a) identify mechanisms that may result in differential&#xD;
      program effectiveness across racial groups, and (b) adapt such a program (TIM&amp;SARA) so youth&#xD;
      from diverse racial backgrounds benefit similarly. Freshmen in an urban high-school will&#xD;
      participate in TIM&amp;SARA, fill out surveys and give biological data in saliva.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Already in adolescence, substantial disparities between African-Americans and&#xD;
      European-Americans regarding academic outcomes, mental health, and physical health like&#xD;
      cardiovascular health exist. While these domains are often treated as unrelated, they&#xD;
      influence each other in a way that the disparity in one variable increases the likelihood for&#xD;
      disparity in the others. Depression, a very common mental health problem, plays a central&#xD;
      role by impacting academic outcomes and cardiovascular health. Thus, a program that&#xD;
      successfully reduces the likelihood for youths to develop depression should also reduce&#xD;
      problems with academic outcomes and physical health and therefore reduce disparity in all&#xD;
      three domains. Unfortunately, research demonstrates that European-American youth benefit more&#xD;
      from programs preventing the development of depression than their African-American peers.&#xD;
      Thus, the main goals of this research project are to (a) identify mechanisms that may result&#xD;
      in differential prevention program effectiveness across youth race groups, and (b) adapt such&#xD;
      a program (TIM&amp;SARA) so youth from diverse racial backgrounds benefit similarly.&#xD;
&#xD;
      In this project, the depression prevention program TIM&amp;SARA will be implemented as part of&#xD;
      the normal school curriculum for freshmen in an urban high-school. The differential effects&#xD;
      of the program on African-American and European-American youths will be examined using&#xD;
      surveys and biological data in saliva.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID epidemic &amp; measures to control it&#xD;
  </why_stopped>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Center for Epidemiological Studies - Depression Scale (CES-D)</measure>
    <time_frame>5 minutes</time_frame>
    <description>The CES-D is a 20-item self-report instrument which has been repeatedly used in adolescent samples (e.g., Roberts et al., 1990) will be used. Items are rated on a 4-point Likert scale (0 = rarely or none of the time; 3 = most of the time; e.g., &quot;I was bothered by things that usually don't bother me.&quot;). The scale ranges from 0-60; total scores of 16 or higher indicate clinically significant depressive symptoms. The internal consistency of the CES-D in previous studies with adolescents is good (α = .92, Winkeljohn Black, &amp; Pössel, 2015).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">740</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Prevention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TIM&amp;SARA has a duration of 16 fifty-minute sessions and is organized in five modules. The first module (2 sessions) outlines the rationale for the program and establishes connections between group leaders and adolescents. The next module (2 sessions) focuses on helping adolescents to consider already existing goals, set new ones, and learn how to achieve goals to build up the motivation of the youth to learn and apply the material of the following modules. The third module (6 sessions) focuses on understanding the relations among cognitions, emotions, and behaviors, and teaching the participating youths how to identify and challenge negative cognitions. The forth module (5 sessions) trains the youth in assertive and social competent social behavior. Finally, the last session is a review session and includes a celebration. All parts of the program use illustrative, culturally relevant situations introduced by the participating adolescents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The youth participate in school as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TIM&amp;SARA</intervention_name>
    <arm_group_label>Prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  9th grade students in the participating high school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Possel, Dr.rer.soc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisville</affiliation>
  </overall_official>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Patrick Possel</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03831139
org study id: 15.0318
nct id: NCT03831139
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Disparities between African-American and European-American youth regarding academic outcomes,
      mental health, and physical health exist. Depression, a very common mental health problem,
      plays a central role by impacting academic outcomes and cardiovascular health. Thus, a
      program that successfully reduces the likelihood for youths to develop depression should also
      reduce problems with academic outcomes and physical health and therefore reduce disparity in
      all three domains. Research demonstrates that European-American youth benefit more from
      programs preventing the development of depression than their African-American peers. Thus,
      the goals of this project are to (a) identify mechanisms that may result in differential
      program effectiveness across racial groups, and (b) adapt such a program (TIM&SARA) so youth
      from diverse racial backgrounds benefit similarly. Freshmen in an urban high-school will
      participate in TIM&SARA, fill out surveys and give biological data in saliva.
Already in adolescence, substantial disparities between African-Americans and
      European-Americans regarding academic outcomes, mental health, and physical health like
      cardiovascular health exist. While these domains are often treated as unrelated, they
      influence each other in a way that the disparity in one variable increases the likelihood for
      disparity in the others. Depression, a very common mental health problem, plays a central
      role by impacting academic outcomes and cardiovascular health. Thus, a program that
      successfully reduces the likelihood for youths to develop depression should also reduce
      problems with academic outcomes and physical health and therefore reduce disparity in all
      three domains. Unfortunately, research demonstrates that European-American youth benefit more
      from programs preventing the development of depression than their African-American peers.
      Thus, the main goals of this research project are to (a) identify mechanisms that may result
      in differential prevention program effectiveness across youth race groups, and (b) adapt such
      a program (TIM&SARA) so youth from diverse racial backgrounds benefit similarly.

      In this project, the depression prevention program TIM&SARA will be implemented as part of
      the normal school curriculum for freshmen in an urban high-school. The differential effects
      of the program on African-American and European-American youths will be examined using
      surveys and biological data in saliva.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Center for Epidemiological Studies - Depression Scale (CES-D)
time frame: 5 minutes
description: The CES-D is a 20-item self-report instrument which has been repeatedly used in adolescent samples (e.g., Roberts et al., 1990) will be used. Items are rated on a 4-point Likert scale (0 = rarely or none of the time; 3 = most of the time; e.g., "I was bothered by things that usually don't bother me."). The scale ranges from 0-60; total scores of 16 or higher indicate clinically significant depressive symptoms. The internal consistency of the CES-D in previous studies with adolescents is good (α = .92, Winkeljohn Black, & Pössel, 2015).
arm group label: Prevention
arm group type: Experimental
description: TIM&SARA has a duration of 16 fifty-minute sessions and is organized in five modules. The first module (2 sessions) outlines the rationale for the program and establishes connections between group leaders and adolescents. The next module (2 sessions) focuses on helping adolescents to consider already existing goals, set new ones, and learn how to achieve goals to build up the motivation of the youth to learn and apply the material of the following modules. The third module (6 sessions) focuses on understanding the relations among cognitions, emotions, and behaviors, and teaching the participating youths how to identify and challenge negative cognitions. The forth module (5 sessions) trains the youth in assertive and social competent social behavior. Finally, the last session is a review session and includes a celebration. All parts of the program use illustrative, culturally relevant situations introduced by the participating adolescents.
arm group label: Control
arm group type: No Intervention
description: The youth participate in school as usual.
intervention type: Behavioral
intervention name: TIM&SARA
arm group label: Prevention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick Possel, Dr.rer.soc.
role: Principal Investigator
affiliation: University of Louisville
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Patrick Possel
investigator title: Professor
mesh term: Depression
sharing ipd: No