<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/NCT04496453</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101904</org_study_id>
    <secondary_id>1KL2TR002554</secondary_id>
    <nct_id>NCT04496453</nct_id>
  </id_info>
  <brief_title>Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations</brief_title>
  <acronym>ADEPT</acronym>
  <official_title>Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop and evaluate a tool designed to help parents make&#xD;
      decisions about childhood vaccines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2020</start_date>
  <completion_date type="Actual">March 24, 2022</completion_date>
  <primary_completion_date type="Actual">March 24, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire</measure>
    <time_frame>pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)</time_frame>
    <description>Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Acceptability of Childhood Vaccinations</measure>
    <time_frame>pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Vaccine Refusal</condition>
  <arm_group>
    <arm_group_label>Childhood vaccination decision support tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive childhood vaccination decision support tool</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Childhood vaccination decision support tool</intervention_name>
    <description>Participants receive childhood vaccination decision support tool</description>
    <arm_group_label>Childhood vaccination decision support tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Parent or primary caregiver of a child between the ages of 3-6 years who is receiving&#xD;
             primary care at Duke.&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand the study objectives, procedures, risks, and benefits&#xD;
&#xD;
          -  Unable to consent for themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lavanya Vasudevan, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <results_first_submitted>March 14, 2023</results_first_submitted>
  <results_first_submitted_qc>April 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 18, 2023</results_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>childhood vaccines</keyword>
  <keyword>vaccine hesitancy</keyword>
  <keyword>vaccination</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 16, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT04496453/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT04496453/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Childhood Vaccination Decision Support Tool</title>
          <description>Participants receive childhood vaccination decision support tool&#xD;
Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Childhood Vaccination Decision Support Tool</title>
          <description>Participants receive childhood vaccination decision support tool&#xD;
Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.06" spread="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire</title>
        <description>Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.</description>
        <time_frame>pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)</time_frame>
        <population>Participants who completed both questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Childhood Vaccination Decision Support Tool</title>
            <description>Participants receive childhood vaccination decision support tool&#xD;
Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire</title>
          <description>Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.</description>
          <population>Participants who completed both questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Acceptability of Childhood Vaccinations</title>
        <time_frame>pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Childhood Vaccination Decision Support Tool</title>
            <description>Participants receive childhood vaccination decision support tool&#xD;
Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Acceptability of Childhood Vaccinations</title>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 4-6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Childhood Vaccination Decision Support Tool</title>
          <description>Participants receive childhood vaccination decision support tool&#xD;
Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lavanya Vasudevan, Ph.D., M.P.H., C.P.H.</name_or_title>
      <organization>Emory University</organization>
      <phone>404-727-3956</phone>
      <email>lavanya.vasudevan@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04496453
org study id: Pro00101904
secondary id: 1KL2TR002554
nct id: NCT04496453
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop and evaluate a tool designed to help parents make
      decisions about childhood vaccines.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
description: Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.
measure: Change in Acceptability of Childhood Vaccinations
time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
arm group label: Childhood vaccination decision support tool
arm group type: Experimental
description: Participants receive childhood vaccination decision support tool
intervention type: Other
intervention name: Childhood vaccination decision support tool
description: Participants receive childhood vaccination decision support tool
arm group label: Childhood vaccination decision support tool
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lavanya Vasudevan, Ph.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 