The Sunscreen for Kindergarteners (SKIN) Study trial protocol
Exposure to ultraviolet radiation (UVR) is the major modifiable risk factor for skin cancers. The majority of lifetime UVR exposure occurs before age 20, underscoring an important window for risk reduction. Incorporation of skills-based sunscreen education into school health curricula may foster the...
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| Published in | Contemporary clinical trials Vol. 107; p. 106480 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.08.2021
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| Subjects | |
| Online Access | Get full text |
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| Summary: | Exposure to ultraviolet radiation (UVR) is the major modifiable risk factor for skin cancers. The majority of lifetime UVR exposure occurs before age 20, underscoring an important window for risk reduction. Incorporation of skills-based sunscreen education into school health curricula may foster the development of consistent and effective use of sunscreen among children and youth. We describe the study protocol for a first-of-its-kind study that examined the feasibility of bringing skills-based sunscreen education into kindergarten classrooms.
Participants were 96 kindergarten students across four classrooms in a single elementary school. A single-blind open-label trial design was used to evaluate the feasibility of incorporating a song-based, video-guided intervention for independent application of sunscreen into the kindergarten curriculum. Students first completed a 10-day no-intervention baseline period, followed by a 10-day intervention period, and then a 10-day randomized follow-up period where students were randomly assigned to continue with the intervention or to revert to the no-intervention condition.
Feasibility metrics associated with study process, resources, management, scientific outcomes and safety were gathered. The primary outcome was pre-to-post intervention changes in student engagement in the sunscreen task. The secondary outcome was pre-to-post intervention changes in the proportion of exposed skin to which a student applies sunscreen. Teacher and student perceptions of intervention value and utility were also evaluated.
This is the study protocol for a clinical trial designed to determine the feasibility of implementing a skills-based sunscreen curriculum in kindergarten classrooms. Next steps include evaluation of the intervention for efficacy and effectiveness.
Clinical Trial Registration: NCT03752736 |
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| Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 Authors’ contributions All authors contributed collaboratively to the conceptualization of the project, including study methodology, data collection procedures and intervention. GHL was the lead on the development of the interventional video, oversaw key aspects of study administration including obtaining of informed consent from parents and teachers, weighing sunscreen bottles weekly during the intervention, and contributed to both original writing and review/editing of the manuscript. KR contributed to the video intervention used in the study and drafted the manuscript. GB led the development of the funding proposal and the original study proposal; he also contributed to the original writing (drafting) and editing of this manuscript. LB also contributed to the development of funding and study proposals and led efforts to create the study database. She was involved in key elements of the investigation, including observing and rating student performance on the sunscreen task, and contributed to the editing, review and revising of this manuscript. MPR contributed to the video intervention used in the study and to the acquisition of the data, including observing and rating student performance on the sunscreen task. She served a supervisory role in this project, together with KN, overseeing trainee participation in this project. She also contributed to the drafting and editing of this manuscript. KN was the overall study PI and oversaw the development of study design, implementation, oversight of the team, acquisition of the data, and observation of students. Together with JW and MPR she supervised the trainees on this project, led efforts to validate the observational scoring strategies used by study staff who observed students, and helped develop all materials associated with the project. JW was a co-Principal Investigator. She also helped lead the proposal and protocol development, contributed to study design, served as liaison to the participating school, and drafted the manuscript. YL and MBC contributed to the design of the study and the planned data analysis. All authors have read approved the final manuscript. |
| ISSN: | 1551-7144 1559-2030 1559-2030 |
| DOI: | 10.1016/j.cct.2021.106480 |