<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/NCT04448210</url>
  </required_header>
  <id_info>
    <org_study_id>R44NR019565</org_study_id>
    <nct_id>NCT04448210</nct_id>
  </id_info>
  <brief_title>Web-based Resource for Children and Adolescents About Clinical Research</brief_title>
  <official_title>Web-based Resource for Children and Adolescents About Clinical Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovation Research &amp; Training</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovation Research &amp; Training</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>
      The overall aims of this project are to: 1) create a developmentally appropriate interactive&#xD;
      educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the&#xD;
      feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and&#xD;
      youth assent will be sought. Participants will be randomized into one of two study arms:&#xD;
      intervention and wait-list control. All participants will complete a web-based pre-test&#xD;
      questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News:&#xD;
      Teen for one week. Approximately one week after completing the pre-test questionnaire, all&#xD;
      participants will complete a web-based post-test questionnaire (the post-test for youth in&#xD;
      the intervention group will also include Consumer Satisfaction Questions). Youth in the&#xD;
      wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After&#xD;
      one week, they will complete a Consumer Satisfaction Questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">August 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 19, 2020</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attitudes Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beliefs Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy to Communicate Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy to Gather Information Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Confidence Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedural Fears Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Likelihood of Participation Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear Preventing Participation Scores at 1 Week</measure>
    <time_frame>1 week</time_frame>
    <description>Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <condition>Chronic Illnesses, Multiple</condition>
  <arm_group>
    <arm_group_label>Educational website intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DigiKnowIt News: Teen</intervention_name>
    <description>Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
    <arm_group_label>Educational website intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be between the ages of 12 and 17 years.&#xD;
&#xD;
          -  Participants must have access to a computer or tablet with Internet connection.&#xD;
&#xD;
          -  Participants must be able to read and write in English fluently.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must NOT have previously participated in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Parker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Innovation Research &amp; Training</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>innovation Research &amp; Training</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <results_first_submitted>September 28, 2020</results_first_submitted>
  <results_first_submitted_qc>November 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2020</results_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Innovation Research &amp; Training</investigator_affiliation>
    <investigator_full_name>Alison Parker</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Multiple Chronic Conditions</mesh_term>
  </condition_browse>
  <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>June 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT04448210/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Educational Website Intervention</title>
          <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
        </group>
        <group group_id="P2">
          <title>Wait-list Control</title>
          <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Educational Website Intervention</title>
          <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
        </group>
        <group group_id="B2">
          <title>Wait-list Control</title>
          <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="42"/>
          </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="14.14" spread="1.78"/>
                    <measurement group_id="B2" value="14.55" spread="1.64"/>
                    <measurement group_id="B3" value="14.33" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Binary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Knowledge Scores</title>
          <description>Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores was from 0 to 46. Higher scores indicate more knowledge about clinical research.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.74" spread="4.96"/>
                    <measurement group_id="B2" value="36.25" spread="4.04"/>
                    <measurement group_id="B3" value="36.00" spread="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Attitudes Scores</title>
          <description>Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5.&#xD;
Higher scores indicate more positive attitudes toward clinical trials.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.76" spread=".75"/>
                    <measurement group_id="B2" value="3.85" spread=".65"/>
                    <measurement group_id="B3" value="3.80" spread=".70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Beliefs Scores</title>
          <description>Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.11" spread=".64"/>
                    <measurement group_id="B2" value="4.21" spread=".51"/>
                    <measurement group_id="B3" value="4.16" spread=".58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Self-Efficacy for Gathering Information Scores</title>
          <description>Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.23" spread=".61"/>
                    <measurement group_id="B2" value="4.21" spread=".52"/>
                    <measurement group_id="B3" value="4.22" spread=".56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Self-Efficacy to Communicate Scores</title>
          <description>Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.49" spread=".61"/>
                    <measurement group_id="B2" value="4.56" spread=".54"/>
                    <measurement group_id="B3" value="4.52" spread=".57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Confidence Scores</title>
          <description>Youth will be asked to respond to additional items3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.39" spread=".67"/>
                    <measurement group_id="B2" value="3.35" spread=".63"/>
                    <measurement group_id="B3" value="3.37" spread=".64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Procedural Fears Scores</title>
          <description>Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.28" spread=".75"/>
                    <measurement group_id="B2" value="2.46" spread=".80"/>
                    <measurement group_id="B3" value="2.37" spread=".77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Likelihood of Participation Scores</title>
          <description>Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.57" spread=".98"/>
                    <measurement group_id="B2" value="3.74" spread=".81"/>
                    <measurement group_id="B3" value="3.65" spread=".89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Fear Preventing Participation Scores</title>
          <description>Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.29" spread=".78"/>
                    <measurement group_id="B2" value="2.35" spread="1.09"/>
                    <measurement group_id="B3" value="2.32" spread=".93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Knowledge Scores at 1 Week</title>
        <description>Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.</description>
        <time_frame>1 week</time_frame>
        <population>In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Knowledge Scores at 1 Week</title>
          <description>Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.</description>
          <population>In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.32" spread="1.00"/>
                    <measurement group_id="O2" value="36.93" spread=".94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.25</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Attitudes Scores at 1 Week</title>
        <description>Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Attitudes Scores at 1 Week</title>
          <description>Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.92" spread=".09"/>
                    <measurement group_id="O2" value="3.87" spread=".09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.72</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Beliefs Scores at 1 Week</title>
        <description>Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Beliefs Scores at 1 Week</title>
          <description>Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread=".09"/>
                    <measurement group_id="O2" value="4.23" spread=".09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.16</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-Efficacy to Communicate Scores at 1 Week</title>
        <description>Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy to Communicate Scores at 1 Week</title>
          <description>Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.59" spread=".10"/>
                    <measurement group_id="O2" value="4.48" spread=".10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.43</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-Efficacy to Gather Information Scores at 1 Week</title>
        <description>Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy to Gather Information Scores at 1 Week</title>
          <description>Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread=".09"/>
                    <measurement group_id="O2" value="4.38" spread=".09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.69</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Confidence Scores at 1 Week</title>
        <description>Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Confidence Scores at 1 Week</title>
          <description>Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread=".14"/>
                    <measurement group_id="O2" value="3.73" spread=".14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.38</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Procedural Fears Scores at 1 Week</title>
        <description>Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Fears Scores at 1 Week</title>
          <description>Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread=".10"/>
                    <measurement group_id="O2" value="2.24" spread=".10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.94</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Likelihood of Participation Scores at 1 Week</title>
        <description>Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.</description>
        <time_frame>1 week</time_frame>
        <population>In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Likelihood of Participation Scores at 1 Week</title>
          <description>Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.</description>
          <population>In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.63" spread=".15"/>
                    <measurement group_id="O2" value="3.65" spread=".15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.94</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fear Preventing Participation Scores at 1 Week</title>
        <description>Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.</description>
        <time_frame>1 week</time_frame>
        <population>In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Website Intervention</title>
            <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list Control</title>
            <description>The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).</description>
          </group>
        </group_list>
        <measure>
          <title>Fear Preventing Participation Scores at 1 Week</title>
          <description>Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.</description>
          <population>In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread=".18"/>
                    <measurement group_id="O2" value="2.40" spread=".18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.30</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline to end of intervention at 1 week</time_frame>
      <desc>The participants in the study completed web-based questionnaires and utilized an educational website (if in the intervention group). The risks associated with this study were minimal and the participants were not at risk for mortality as a function of participating in this study. Because this study investigated an online behavioral intervention, All-Cause Mortality was not monitored or assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Educational Website Intervention</title>
          <description>The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.&#xD;
DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.</description>
        </group>
        <group group_id="E2">
          <title>Wait-list Control</title>
          <description>This is a wait-list control group and they did not receive an intervention.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Alison Parker</name_or_title>
      <organization>innovation Research &amp; Training</organization>
      <phone>919-493-7700</phone>
      <email>aparker@irtinc.us</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/NCT04448210
org study id: R44NR019565
nct id: NCT04448210
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall aims of this project are to: 1) create a developmentally appropriate interactive
      educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the
      feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.
Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and
      youth assent will be sought. Participants will be randomized into one of two study arms:
      intervention and wait-list control. All participants will complete a web-based pre-test
      questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News:
      Teen for one week. Approximately one week after completing the pre-test questionnaire, all
      participants will complete a web-based post-test questionnaire (the post-test for youth in
      the intervention group will also include Consumer Satisfaction Questions). Youth in the
      wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After
      one week, they will complete a Consumer Satisfaction Questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Knowledge Scores at 1 Week
time frame: 1 week
description: Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.
measure: Attitudes Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.
measure: Beliefs Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.
measure: Self-Efficacy to Communicate Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.
measure: Self-Efficacy to Gather Information Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.
measure: Confidence Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.
measure: Procedural Fears Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to 4 questions related to their perceptions of fear or anxiety about different types of medical procedures, including getting a needle in the arm, injection in the leg, getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or anxious, 5 = Extremely afraid or anxious). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.
measure: Likelihood of Participation Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to one question about the likelihood of participating in a clinical trial (i.e., If you were asked to be in a clinical trial, how likely would you be to participate?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.
measure: Fear Preventing Participation Scores at 1 Week
time frame: 1 week
description: Youth will be asked to respond to one question about the likelihood of their fear preventing them from participating in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from participating in a clinical trial in the future?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.
arm group label: Educational website intervention
arm group type: Experimental
description: The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.
arm group label: Wait-list control
arm group type: No Intervention
description: The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
intervention type: Behavioral
intervention name: DigiKnowIt News: Teen
description: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.
arm group label: Educational website intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alison Parker, PhD
role: Principal Investigator
affiliation: Innovation Research & Training
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Innovation Research & Training
investigator full name: Alison Parker
investigator title: Research Scientist
mesh term: Chronic Disease
mesh term: Multiple Chronic Conditions
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 