<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/NCT03752736</url>
  </required_header>
  <id_info>
    <org_study_id>46831</org_study_id>
    <nct_id>NCT03752736</nct_id>
  </id_info>
  <brief_title>Sun Safety Skills for Elementary School Students</brief_title>
  <official_title>Sun Safety Skills for Elementary School Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching goal of this work is to pilot-test a song-based instructional video designed&#xD;
      to help elementary school (kindergarten) age children independently apply sunscreen&#xD;
      effectively (i.e., covers all needed areas), efficiently (i.e., can be accomplished in 2-3&#xD;
      minutes), consistently (i.e., continues to apply sunscreen routinely before recess both&#xD;
      during and after the intervention), without impacting classroom function (i.e., no mess). The&#xD;
      video is also designed to encourage use of hats and sunglasses. The outcomes of interest&#xD;
      include identification of &quot;gaps&quot; in skills that are consistent for this age group (i.e.,&#xD;
      commonly miss application to the back of neck), areas of learning refinement (i.e.,&#xD;
      generalization of skills with different outfits on), and flexibility in terms of adapting&#xD;
      practice (i.e., can they do it without the video). The investigators hope that this pilot&#xD;
      project will pave the way for broader clinical / educational implementation of this&#xD;
      intervention within schools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will use an unblinded, open label, A-B design with a randomized follow-up&#xD;
      period to evaluate the study objectives. The primary aim is to characterize the proportion of&#xD;
      students (per class and total, or across classes) who productively engage in the in-classroom&#xD;
      sunscreen application tasks when using the video guided sunscreen intervention (i.e., success&#xD;
      is defined as any appropriate participation with video guided tasks, completing tasks and&#xD;
      putting sunscreen away, sitting down by end of 2 minute, 42 second video intervention)&#xD;
      relative to the proportion who achieve success (i.e., any appropriate effort to apply&#xD;
      sunscreen, put away sunscreen and sit down within a two minute window) WITHOUT use of the&#xD;
      video.&#xD;
&#xD;
      One hundred eight kindergarten students across four kindergarten classrooms (N = 27 per&#xD;
      class) will complete a two-week baseline period in which the participants are provide a&#xD;
      2-minute window and allowed access to their sunscreen without instruction. Classroom&#xD;
      teachers, trained to score our primary outcome (child does/does not complete this task within&#xD;
      two-minute window), will evaluate outcomes for each child daily for two weeks (baseline&#xD;
      period). Percentage of students who are able to complete this task is our primary endpoint.&#xD;
      Change trajectories from beginning to end of the baseline period (Time 1/Day 1 - Time 2/Day&#xD;
      10) and from the beginning to end of treatment (Time 2 - Time 3) will be calculated for each&#xD;
      class. The average percentage of the second week in the baseline period and the second week&#xD;
      in the intervention period will be used to calculate the successful rate for each period with&#xD;
      95% confidence intervals.&#xD;
&#xD;
      To address a subsidiary aim, related to whether or not student competence with sunscreen&#xD;
      application (systematic, % of body covered / body parts neglected, and completeness of&#xD;
      coverage of face) is impacted by the video intervention, a randomly selected subset of&#xD;
      students will be evaluated by a trained member of the study team for competence of&#xD;
      application at Time 1,2, 3 and 4. Changes trajectories will be calculated by class for this&#xD;
      subset of students.&#xD;
&#xD;
      At the study outset, all four classrooms will be randomized to either an &quot;extended&#xD;
      intervention&quot; (EI) or &quot;maintenance&quot; (M) condition using a 1:1 randomization scheme. This will&#xD;
      offer some descriptive, feasibility data regarding the tolerability of randomization by&#xD;
      classroom, and a preliminary look at dose-response trends and short-term maintenance effects.&#xD;
      Upon completion of the two-week baseline period and two-week standard intervention period,&#xD;
      the two classrooms assigned to the EI condition will receive the video-based intervention for&#xD;
      two additional weeks and the two classrooms assigned to the M condition will continue to&#xD;
      receive a two- minute window for sunscreen application, but no video-based instruction.&#xD;
      Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up&#xD;
      assignment condition and will provide preliminary information about dosing and maintenance&#xD;
      effects.&#xD;
&#xD;
      Student, teacher, parent and administrator perceptions of the acceptability, value and&#xD;
      utility of the intervention will be assessed at a single time point at the conclusion of the&#xD;
      study.&#xD;
&#xD;
      Study Setting and Participants:&#xD;
&#xD;
      General Education Kindergarten students who meet all study eligibility requirements (i.e.,&#xD;
      including health requirements appropriate to the use of sunscreen) and who assent to&#xD;
      participate and who receive parental consent to participate at Sedgwick Elementary School&#xD;
      will be included in the present study. Special education students who are mainstreamed may&#xD;
      also be considered eligible to participate via consensus from both parent and teacher.&#xD;
&#xD;
      Recruitment and screening: Recruitment efforts will include collaborative (research team +&#xD;
      kinder teachers) efforts to provide parents an overview of the study goals and objectives,&#xD;
      and to obtain consent/assent. The investigators will plan to have a parent-focused meeting in&#xD;
      the weeks prior to the commencement of the study.&#xD;
&#xD;
      Intervention: The song-based video guided sun screen intervention is 2-3 minutes long, with&#xD;
      30 seconds allotted at the beginning for students to prepare their sunscreen materials and&#xD;
      get ready, two minutes of instruction that guides their application of sunscreen to all&#xD;
      exposed areas of skin starting with their head and working systematically down to their feet,&#xD;
      and then 30 seconds of guided instruction for putting the sunscreen materials away and&#xD;
      sitting back down at their desks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">May 23, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen.</measure>
    <time_frame>Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)</time_frame>
    <description>Change in the proportion of kindergarten students who successfully complete independent self-application of sunscreen within the allotted 2.5 minute time window from baseline (Time 1) to posttreatment (Time 2). Successful completion of the sun screen task (i.e., Kinder Students' self-application of sunscreen within the 2.5 minute window allotted by the intervention) will be determined via direct observation by the classroom teacher. Teachers will be formally trained by the study staff to rate student performance (i.e., successful/not successful) with self-application of sunscreen per a manualized study protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen</measure>
    <time_frame>Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)</time_frame>
    <description>Teacher identified barriers, or the cognitive, emotional, behavioral, environmental, factors that interfered with a student's successful completion of the self-application of sunscreen task will be recorded by the classroom teacher daily during the sunscreen intervention. This descriptive outcome will be qualitative (i.e., teacher generated list).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Teacher, parent and administrator perceptions of intervention utility.</measure>
    <time_frame>Posttreatment (Time 2; up to 15 minutes)</time_frame>
    <description>Teacher, parents and administrators respond to a single item question, &quot;In your opinion, how useful was this intervention in terms of getting students engaged in sun protective behavior?&quot; This single item is modeled after utility questions used in health services research and educational research, and will be scored on an 11-point likert type scale, where &quot;0&quot; indicates not at all useful; and &quot;10&quot; indicates very useful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Teacher, parent and administrator perceptions of intervention value.</measure>
    <time_frame>Posttreatment (Time 2; up to 15 minutes)</time_frame>
    <description>Teacher, parents and administrators respond to a single item question &quot;In your opinion, how valuable was this intervention to your overall curriculum? This single item is modeled after value questions used in health services and educational research and will be Responses will be scored on an 11-point likert type scale, where a score of &quot;0&quot; indicates not at all valuable and a score of &quot;10&quot; indicates very valuable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Student perceptions of intervention likability</measure>
    <time_frame>Posttreatment (Time 2; up to 15 minutes)</time_frame>
    <description>Kinder students respond to a single item question &quot;Did you like the sunscreen video? &quot; As Kinder students are not proficient readers, this question will be read aloud to the class, and students will respond individually by casting a &quot;secret ballot&quot; in a voting booth set up in the classroom- -under the direct supervision of the study staff. &quot;Yes&quot; votes will be cast using a piece of paper with a happy face on it; &quot;no&quot; votes will be cast using a piece of paper with a sad face on it. In this way, students can respond individually to this question without having to read, tell their answer to the teacher, and without undue influence of their peers. Results will be tallied by class.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Sunburn</condition>
  <condition>Skin Cancer Prevention</condition>
  <arm_group>
    <arm_group_label>Extended intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the Extended intervention condition will receive the &quot;I wear sunscreen everyday&quot; song-based video intervention daily for two additional weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The two classrooms assigned to the Maintenance condition will continue to receive a two- minute window for sunscreen application, but no &quot;I wear sunscreen everyday&quot; song-based video instruction.&#xD;
Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;I wear sunscreen everyday&quot; song-based video</intervention_name>
    <description>All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled &quot;I wear sunscreen everyday&quot; in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet.</description>
    <arm_group_label>Extended intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General education Kinder students (Sedgwick Elementary School in 2018-2019).&#xD;
&#xD;
          -  Child assent and parental consent are required to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-general education status;&#xD;
&#xD;
          -  significant medical, mental health and/or behavioral problem&#xD;
&#xD;
          -  child refusal of assent or parental refusal of consent;&#xD;
&#xD;
          -  known or identified allergy to ingredients in sunscreen;&#xD;
&#xD;
          -  moving out of the grade or school during the intervention or follow-up period;&#xD;
&#xD;
          -  participation in a concurrent sunscreen intervention protocol are exclusionary&#xD;
             criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Nord, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sedgwick Elementary School</name>
      <address>
        <city>Cupertino</city>
        <state>California</state>
        <zip>95014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>August 10, 2019</last_update_submitted>
  <last_update_submitted_qc>August 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Kristin M. Nord</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Sunscreen</keyword>
  <keyword>Sun protection</keyword>
  <keyword>Education</keyword>
  <keyword>skin cancer</keyword>
  <keyword>school-aged children</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Sunburn</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunscreening Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03752736
org study id: 46831
nct id: NCT03752736
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The overarching goal of this work is to pilot-test a song-based instructional video designed
      to help elementary school (kindergarten) age children independently apply sunscreen
      effectively (i.e., covers all needed areas), efficiently (i.e., can be accomplished in 2-3
      minutes), consistently (i.e., continues to apply sunscreen routinely before recess both
      during and after the intervention), without impacting classroom function (i.e., no mess). The
      video is also designed to encourage use of hats and sunglasses. The outcomes of interest
      include identification of "gaps" in skills that are consistent for this age group (i.e.,
      commonly miss application to the back of neck), areas of learning refinement (i.e.,
      generalization of skills with different outfits on), and flexibility in terms of adapting
      practice (i.e., can they do it without the video). The investigators hope that this pilot
      project will pave the way for broader clinical / educational implementation of this
      intervention within schools.
The investigators will use an unblinded, open label, A-B design with a randomized follow-up
      period to evaluate the study objectives. The primary aim is to characterize the proportion of
      students (per class and total, or across classes) who productively engage in the in-classroom
      sunscreen application tasks when using the video guided sunscreen intervention (i.e., success
      is defined as any appropriate participation with video guided tasks, completing tasks and
      putting sunscreen away, sitting down by end of 2 minute, 42 second video intervention)
      relative to the proportion who achieve success (i.e., any appropriate effort to apply
      sunscreen, put away sunscreen and sit down within a two minute window) WITHOUT use of the
      video.

      One hundred eight kindergarten students across four kindergarten classrooms (N = 27 per
      class) will complete a two-week baseline period in which the participants are provide a
      2-minute window and allowed access to their sunscreen without instruction. Classroom
      teachers, trained to score our primary outcome (child does/does not complete this task within
      two-minute window), will evaluate outcomes for each child daily for two weeks (baseline
      period). Percentage of students who are able to complete this task is our primary endpoint.
      Change trajectories from beginning to end of the baseline period (Time 1/Day 1 - Time 2/Day
      10) and from the beginning to end of treatment (Time 2 - Time 3) will be calculated for each
      class. The average percentage of the second week in the baseline period and the second week
      in the intervention period will be used to calculate the successful rate for each period with
      95% confidence intervals.

      To address a subsidiary aim, related to whether or not student competence with sunscreen
      application (systematic, % of body covered / body parts neglected, and completeness of
      coverage of face) is impacted by the video intervention, a randomly selected subset of
      students will be evaluated by a trained member of the study team for competence of
      application at Time 1,2, 3 and 4. Changes trajectories will be calculated by class for this
      subset of students.

      At the study outset, all four classrooms will be randomized to either an "extended
      intervention" (EI) or "maintenance" (M) condition using a 1:1 randomization scheme. This will
      offer some descriptive, feasibility data regarding the tolerability of randomization by
      classroom, and a preliminary look at dose-response trends and short-term maintenance effects.
      Upon completion of the two-week baseline period and two-week standard intervention period,
      the two classrooms assigned to the EI condition will receive the video-based intervention for
      two additional weeks and the two classrooms assigned to the M condition will continue to
      receive a two- minute window for sunscreen application, but no video-based instruction.
      Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up
      assignment condition and will provide preliminary information about dosing and maintenance
      effects.

      Student, teacher, parent and administrator perceptions of the acceptability, value and
      utility of the intervention will be assessed at a single time point at the conclusion of the
      study.

      Study Setting and Participants:

      General Education Kindergarten students who meet all study eligibility requirements (i.e.,
      including health requirements appropriate to the use of sunscreen) and who assent to
      participate and who receive parental consent to participate at Sedgwick Elementary School
      will be included in the present study. Special education students who are mainstreamed may
      also be considered eligible to participate via consensus from both parent and teacher.

      Recruitment and screening: Recruitment efforts will include collaborative (research team +
      kinder teachers) efforts to provide parents an overview of the study goals and objectives,
      and to obtain consent/assent. The investigators will plan to have a parent-focused meeting in
      the weeks prior to the commencement of the study.

      Intervention: The song-based video guided sun screen intervention is 2-3 minutes long, with
      30 seconds allotted at the beginning for students to prepare their sunscreen materials and
      get ready, two minutes of instruction that guides their application of sunscreen to all
      exposed areas of skin starting with their head and working systematically down to their feet,
      and then 30 seconds of guided instruction for putting the sunscreen materials away and
      sitting back down at their desks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen.
time frame: Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)
description: Change in the proportion of kindergarten students who successfully complete independent self-application of sunscreen within the allotted 2.5 minute time window from baseline (Time 1) to posttreatment (Time 2). Successful completion of the sun screen task (i.e., Kinder Students' self-application of sunscreen within the 2.5 minute window allotted by the intervention) will be determined via direct observation by the classroom teacher. Teachers will be formally trained by the study staff to rate student performance (i.e., successful/not successful) with self-application of sunscreen per a manualized study protocol.
measure: Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen
time frame: Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)
description: Teacher identified barriers, or the cognitive, emotional, behavioral, environmental, factors that interfered with a student's successful completion of the self-application of sunscreen task will be recorded by the classroom teacher daily during the sunscreen intervention. This descriptive outcome will be qualitative (i.e., teacher generated list).
measure: Teacher, parent and administrator perceptions of intervention utility.
time frame: Posttreatment (Time 2; up to 15 minutes)
description: Teacher, parents and administrators respond to a single item question, "In your opinion, how useful was this intervention in terms of getting students engaged in sun protective behavior?" This single item is modeled after utility questions used in health services research and educational research, and will be scored on an 11-point likert type scale, where "0" indicates not at all useful; and "10" indicates very useful.
measure: Teacher, parent and administrator perceptions of intervention value.
time frame: Posttreatment (Time 2; up to 15 minutes)
description: Teacher, parents and administrators respond to a single item question "In your opinion, how valuable was this intervention to your overall curriculum? This single item is modeled after value questions used in health services and educational research and will be Responses will be scored on an 11-point likert type scale, where a score of "0" indicates not at all valuable and a score of "10" indicates very valuable.
measure: Student perceptions of intervention likability
time frame: Posttreatment (Time 2; up to 15 minutes)
description: Kinder students respond to a single item question "Did you like the sunscreen video? " As Kinder students are not proficient readers, this question will be read aloud to the class, and students will respond individually by casting a "secret ballot" in a voting booth set up in the classroom- -under the direct supervision of the study staff. "Yes" votes will be cast using a piece of paper with a happy face on it; "no" votes will be cast using a piece of paper with a sad face on it. In this way, students can respond individually to this question without having to read, tell their answer to the teacher, and without undue influence of their peers. Results will be tallied by class.
arm group label: Extended intervention
arm group type: Active Comparator
description: Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the Extended intervention condition will receive the "I wear sunscreen everyday" song-based video intervention daily for two additional weeks.
arm group label: Maintenance
arm group type: No Intervention
description: The two classrooms assigned to the Maintenance condition will continue to receive a two- minute window for sunscreen application, but no "I wear sunscreen everyday" song-based video instruction.
Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects.
intervention type: Behavioral
intervention name: "I wear sunscreen everyday" song-based video
description: All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled "I wear sunscreen everyday" in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet.
arm group label: Extended intervention
criteria: 
gender: All
minimum age: 5 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin Nord, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Kristin M. Nord
investigator title: Clinical Professor
mesh term: Skin Neoplasms
mesh term: Sunburn
mesh term: Sunscreening Agents
sharing ipd: No