Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03752736
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase N/A
Start date February 25, 2019
Completion date May 23, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT00206882 - The Sun Protection Effect and Efficacy in Treatment of Sunburn Using Topical Corticosteroids. N/A
Completed NCT05767008 - Water Immersion Studies of a Long-wear Sunscreen to Improve Protection Against Ultraviolet Radiation N/A
Completed NCT00441051 - Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn Phase 3
Completed NCT01873430 - The Sun Protective Effect of Melatonin Phase 1
Completed NCT00326274 - Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream Phase 3
Completed NCT03199573 - Hats on Head Start: A A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs N/A
Terminated NCT03332524 - Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn Phase 2
Completed NCT05260359 - Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol Phase 2
Completed NCT01021787 - Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream Phase 4
Completed NCT03607578 - Test of Interventions to Prevent Skin Cancer Among Danes on Vacation in High UV Index Sunny Destinations N/A
Completed NCT03489356 - Project Options - The ABC Method N/A
Enrolling by invitation NCT03007589 - Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics N/A
Not yet recruiting NCT01085851 - Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms Phase 3
Not yet recruiting NCT01237925 - Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms Phase 3