Sun Safety Skills for Elementary School Students
Condition: Sunburn; Skin Cancer Prevention
MeSH terms: Skin Neoplasms; Sunburn
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): "I wear sunscreen everyday" song-based video
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sunscreen; Sun protection; Education; skin cancer; school-aged children; prevention