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/NCT05965323</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00014531-B</org_study_id>
      <secondary_id>1OT2HD107544-01</secondary_id>
      <nct_id>NCT05965323</nct_id>
    </id_info>
    <brief_title>Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study</brief_title>
    <official_title>Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</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 is a single arm, pre/post intervention study to a larger trial that will examine the&#xD;
        effect of health education with comic books and videos on COVID-19 preventive behaviors&#xD;
        (masking, social distancing, testing and vaccine uptake). The participants are students, ages&#xD;
        3-5 years old and their parents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single arm, pre/post intervention study to a larger trial that will examine the&#xD;
        effect of health education with comic books and videos on COVID-19 preventive behaviors&#xD;
        (masking, social distancing, testing and vaccine uptake). The participants are students, ages&#xD;
        3-5 years old and their parents.&#xD;
  &#xD;
        Students will receive the intervention from November 2023 to March 2024.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 13, 2022</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>School absenteeism</measure>
      <time_frame>Up to nine months</time_frame>
      <description>How many days students miss due to symptoms of respiratory illness</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Absenteeism</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education</intervention_name>
      <description>Health education with comic books and videos</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must have a child attending the Early Learning Program in the Yakima School District&#xD;
  &#xD;
            -  Must be able to provide informed consent and legal guardian assent either virtually,&#xD;
               on the telephone, or in-person.&#xD;
  &#xD;
            -  Must have a permanent mailing address available for study staff to mail necessary&#xD;
               materials OR a working email address.&#xD;
  &#xD;
            -  Must speak English or Spanish.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Not in Early Learning program in Yakima School District&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Linda Ko, PhD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sonia Bishop</last_name>
      <phone>206-685-2947</phone>
      <email>skbishop@uw.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Miriana Duran</last_name>
      <phone>206-221-6206</phone>
      <email>mdp19@uw.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sonia K Bishop, BS</last_name>
        <phone>206-685-2947</phone>
        <email>skbishop@uw.edu</email>
      </contact>
      <contact_backup>
        <last_name>Miriana Duran, MPH</last_name>
        <phone>206-221-6206</phone>
        <email>mdp19@uw.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Linda K Ko, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Linda Ko</investigator_full_name>
      <investigator_title>Professor, School of Public Health</investigator_title>
    </responsible_party>
    <keyword>SARS-coV-2</keyword>
    <keyword>School re-opening</keyword>
    <keyword>Rural Communities</keyword>
    <keyword>Early Education - pre School</keyword>
    <keyword>Risk communication</keyword>
    <!-- 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/NCT05965323
  org study id: STUDY00014531-B
  secondary id: 1OT2HD107544-01
  nct id: NCT05965323
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single arm, pre/post intervention study to a larger trial that will examine the
        effect of health education with comic books and videos on COVID-19 preventive behaviors
        (masking, social distancing, testing and vaccine uptake). The participants are students, ages
        3-5 years old and their parents.
  This is a single arm, pre/post intervention study to a larger trial that will examine the
        effect of health education with comic books and videos on COVID-19 preventive behaviors
        (masking, social distancing, testing and vaccine uptake). The participants are students, ages
        3-5 years old and their parents.
  
        Students will receive the intervention from November 2023 to March 2024.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: School absenteeism
  time frame: Up to nine months
  description: How many days students miss due to symptoms of respiratory illness
  arm group label: Intervention
  arm group type: Experimental
  description: The students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19
  intervention type: Behavioral
  intervention name: Health Education
  description: Health education with comic books and videos
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 5 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Linda Ko, PhD, MPH
  role: Principal Investigator
  affiliation: University of Washington
  last name: Sonia Bishop
  phone: 206-685-2947
  email: skbishop@uw.edu
  last name: Miriana Duran
  phone: 206-221-6206
  email: mdp19@uw.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Linda Ko
  investigator title: Professor, School of Public Health