Sunburn Clinical Trial
Official title:
Sun Safety Skills for Elementary School Students
NCT number | NCT03752736 |
Other study ID # | 46831 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 25, 2019 |
Est. completion date | May 23, 2019 |
Verified date | August 2019 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | May 23, 2019 |
Est. primary completion date | April 11, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 7 Years |
Eligibility |
Inclusion Criteria: - General education Kinder students (Sedgwick Elementary School in 2018-2019). - Child assent and parental consent are required to participate. Exclusion Criteria: - Non-general education status; - significant medical, mental health and/or behavioral problem - child refusal of assent or parental refusal of consent; - known or identified allergy to ingredients in sunscreen; - moving out of the grade or school during the intervention or follow-up period; - participation in a concurrent sunscreen intervention protocol are exclusionary criteria. |
Country | Name | City | State |
---|---|---|---|
United States | Sedgwick Elementary School | Cupertino | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen. | 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. | Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks) | |
Secondary | Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen | 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). | Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks) | |
Secondary | Teacher, parent and administrator perceptions of intervention utility. | 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. | Posttreatment (Time 2; up to 15 minutes) | |
Secondary | Teacher, parent and administrator perceptions of intervention value. | 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. | Posttreatment (Time 2; up to 15 minutes) | |
Secondary | Student perceptions of intervention likability | 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. | Posttreatment (Time 2; up to 15 minutes) |
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