xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05984849</url>
    </required_header>
    <id_info>
      <org_study_id>FP00033005</org_study_id>
      <nct_id>NCT05984849</nct_id>
    </id_info>
    <brief_title>Playing Games to Learn About Children's Vaccines Project</brief_title>
    <official_title>A Pilot Randomized Controlled Study to Examine Feasibility and Preliminary Effectiveness of Game-based Interventions in Promoting Vaccination Among Vulnerable Youth</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michigan State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Michigan State University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This proposed study aims to conduct timely research that promotes vaccine confidence and&#xD;
        vaccination of two strongly recommended vaccines with suboptimal uptake rates: Human&#xD;
        papillomavirus (HPV) and COVID-19 in vulnerable and underserved youth aged 11-14.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study objectives are:&#xD;
  &#xD;
        Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of&#xD;
        two game-based interventions targeting HPV and COVID-19 vaccination.&#xD;
  &#xD;
        Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention;&#xD;
        Arm 2: COVID-19 game-based intervention; Arm 3: usual care). The investigators will explore&#xD;
        patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and&#xD;
        explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth&#xD;
        aged 11-14.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of eligible individuals agreeing to participate</measure>
      <time_frame>T0 (occurs after consenting and before assigning to different study conditions)</time_frame>
      <description>Assessed by the % of eligible individuals agreeing to participate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants who are retained through follow-up</measure>
      <time_frame>T2 (occurs two months after completion of the intervention)</time_frame>
      <description>Assessed by the % of participants who are retained through follow-up</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants who complete the intervention and assessments</measure>
      <time_frame>T2 (occurs two months after completion of the intervention)</time_frame>
      <description>Assessed by the % of participants who complete the intervention and assessments</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participant satisfaction with the project</measure>
      <time_frame>T2 (occurs two months after completion of the intervention)</time_frame>
      <description>Assessed by two Likert scale questions: (1) are you satisfied with the program? (2) Will you recommend this program to others? Responses: from (1) very dissatisfied/definitely not to (5) very satisfied/definitely yes)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intention to vaccinate the children against HPV</measure>
      <time_frame>T0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention)</time_frame>
      <description>Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (1) very unlikely to (5) very likely</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Children receives the first dose of HPV vaccine</measure>
      <time_frame>T2 (occurs two months after completion of the intervention)</time_frame>
      <description>Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>HPV</condition>
    <condition>COVID-19</condition>
    <condition>Vaccine-Preventable Diseases</condition>
    <arm_group>
      <arm_group_label>HPV game group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>parent-child dyads receive HPV game intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>COVID game group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>parent-child dyads receive COVID game intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>parent-child dyads receive usual care (no intervention)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>vaccination games</intervention_name>
      <description>Brief health games to promote two different vaccines among youth</description>
      <arm_group_label>COVID game group</arm_group_label>
      <arm_group_label>HPV game group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child sample: Individuals who (1) are aged 11-14 years, (2) have not received the 1st&#xD;
               dose of HPV or COVID-19 vaccine, (3) can speak and read English, and (4) when&#xD;
               approached, both parent and the child indicate that they do not plan or cannot decide&#xD;
               whether the child will receive the HPV or COVID-19 vaccine.&#xD;
  &#xD;
            -  Parent sample: Individuals who (1) are the parent/caregiver of the participating&#xD;
               child, (2) agree to participate in the research activities. If more than one child in&#xD;
               the same family is eligible for the study, the oldest one who has not received the HPV&#xD;
               or COVID-19 vaccination will be recruited.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals who do not meet inclusion criteria or refuse to provide consent/assent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ANGELA CHEN, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Michigan State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ANGELA CHEN, PhD</last_name>
      <phone>480) 253-9098</phone>
      <email>Healthandgame@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lihong Ou, MS</last_name>
      <phone>480) 253-9098</phone>
      <email>Healthandgame@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Community</name>
        <address>
          <city>Chandler</city>
          <state>Arizona</state>
          <zip>85224</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ANGELA CHEN</last_name>
        <phone>480-253-9098</phone>
        <email>Healthandgame@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Michigan State University</investigator_affiliation>
      <investigator_full_name>Angela Chia-Chen Chen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>adolescent</keyword>
    <keyword>game intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccine-Preventable Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05984849
  org study id: FP00033005
  nct id: NCT05984849
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This proposed study aims to conduct timely research that promotes vaccine confidence and
        vaccination of two strongly recommended vaccines with suboptimal uptake rates: Human
        papillomavirus (HPV) and COVID-19 in vulnerable and underserved youth aged 11-14.
  The study objectives are:
  
        Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of
        two game-based interventions targeting HPV and COVID-19 vaccination.
  
        Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention;
        Arm 2: COVID-19 game-based intervention; Arm 3: usual care). The investigators will explore
        patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and
        explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth
        aged 11-14.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Percentage of eligible individuals agreeing to participate
  time frame: T0 (occurs after consenting and before assigning to different study conditions)
  description: Assessed by the % of eligible individuals agreeing to participate
  measure: Proportion of participants who are retained through follow-up
  time frame: T2 (occurs two months after completion of the intervention)
  description: Assessed by the % of participants who are retained through follow-up
  measure: Percentage of participants who complete the intervention and assessments
  time frame: T2 (occurs two months after completion of the intervention)
  description: Assessed by the % of participants who complete the intervention and assessments
  measure: Participant satisfaction with the project
  time frame: T2 (occurs two months after completion of the intervention)
  description: Assessed by two Likert scale questions: (1) are you satisfied with the program? (2) Will you recommend this program to others? Responses: from (1) very dissatisfied/definitely not to (5) very satisfied/definitely yes)
  measure: Intention to vaccinate the children against HPV
  time frame: T0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention)
  description: Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (1) very unlikely to (5) very likely
  measure: Children receives the first dose of HPV vaccine
  time frame: T2 (occurs two months after completion of the intervention)
  description: Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no
  arm group label: HPV game group
  arm group type: Experimental
  description: parent-child dyads receive HPV game intervention
  arm group label: COVID game group
  arm group type: Experimental
  description: parent-child dyads receive COVID game intervention
  arm group label: Usual care
  arm group type: No Intervention
  description: parent-child dyads receive usual care (no intervention)
  intervention type: Behavioral
  intervention name: vaccination games
  description: Brief health games to promote two different vaccines among youth
  arm group label: COVID game group
  arm group label: HPV game group
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: ANGELA CHEN, PhD
  role: Principal Investigator
  affiliation: Michigan State University
  last name: ANGELA CHEN, PhD
  phone: 480) 253-9098
  email: Healthandgame@gmail.com
  last name: Lihong Ou, MS
  phone: 480) 253-9098
  email: Healthandgame@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Michigan State University
  investigator full name: Angela Chia-Chen Chen
  investigator title: Professor
  mesh term: Vaccine-Preventable Diseases
  sharing ipd: No