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/NCT05977530</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-300011508</org_study_id>
      <nct_id>NCT05977530</nct_id>
    </id_info>
    <brief_title>Teaching Young Children Swim Survival Skills</brief_title>
    <official_title>Teaching Young Children Swim Survival Skills</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alabama at Birmingham</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 study is designed to evaluate whether commercially-available swim self-rescue schools&#xD;
        are effective to teach children ages 12-35 months to stay safely alive floating in the water&#xD;
        without adult intervention. The investigators will measure children's water self-rescue&#xD;
        skills at baseline and then they will engage in commercially-available training over the&#xD;
        course of several sessions. The investigators will then measure their skills again.&#xD;
        Assessments will be conducted using a standardized protocol with a certified lifeguard always&#xD;
        within an arm's reach of the child. Parents will also complete a short survey concerning&#xD;
        child and family demographics and child and family swim and lifeguard training experience.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 2024</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>experimenter-designed standardized behavioral assessment of children's self-rescue ability</measure>
      <time_frame>at completion of training intervention program, an anticipated average of 10 weeks</time_frame>
      <description>assessment of whether children can float alone, without adult assistance, for 1 minute</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Drowning</condition>
    <arm_group>
      <arm_group_label>self-rescue training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>children will receive self-rescue training from a certified instructor</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>self-rescue training</intervention_name>
      <description>children will receive training for self-rescue if they are alone in water</description>
      <arm_group_label>self-rescue training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  child ages 12-35 months&#xD;
  &#xD;
            -  enrolled in self-rescue course at participating swim facility&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  none&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>35 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>UAB Youth Safety Lab, University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35294</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
      <investigator_full_name>David Schwebel</investigator_full_name>
      <investigator_title>University Professor of Psychology &amp; Associate Vice President for Research Facilities &amp; Infrastructure</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Drowning</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will share de-identified data with qualified researchers upon request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will become available after all primary results are published. They will remain available for at least 3 years.</ipd_time_frame>
      <ipd_access_criteria>Contact Study PI David Schwebel.</ipd_access_criteria>
    </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/NCT05977530
  org study id: IRB-300011508
  nct id: NCT05977530
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is designed to evaluate whether commercially-available swim self-rescue schools
        are effective to teach children ages 12-35 months to stay safely alive floating in the water
        without adult intervention. The investigators will measure children's water self-rescue
        skills at baseline and then they will engage in commercially-available training over the
        course of several sessions. The investigators will then measure their skills again.
        Assessments will be conducted using a standardized protocol with a certified lifeguard always
        within an arm's reach of the child. Parents will also complete a short survey concerning
        child and family demographics and child and family swim and lifeguard training experience.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: experimenter-designed standardized behavioral assessment of children's self-rescue ability
  time frame: at completion of training intervention program, an anticipated average of 10 weeks
  description: assessment of whether children can float alone, without adult assistance, for 1 minute
  arm group label: self-rescue training
  arm group type: Experimental
  description: children will receive self-rescue training from a certified instructor
  intervention type: Behavioral
  intervention name: self-rescue training
  description: children will receive training for self-rescue if they are alone in water
  arm group label: self-rescue training
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: 35 Months
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: David Schwebel
  investigator title: University Professor of Psychology & Associate Vice President for Research Facilities & Infrastructure
  mesh term: Drowning
  sharing ipd: Yes
  ipd description: We will share de-identified data with qualified researchers upon request.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will become available after all primary results are published. They will remain available for at least 3 years.
  ipd access criteria: Contact Study PI David Schwebel.