SunburnNCT03752736
Sun Safety Skills for Elementary School Students
A study testing "I wear sunscreen everyday" song-based video in people with Sunburn and Skin Cancer Prevention, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn, Skin Cancer Prevention
- What is being tested?
- "I wear sunscreen everyday" song-based video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 23 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- General education Kinder students (Sedgwick Elementary School in 2018-2019).
- Child assent and parental consent are required to participate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sedgwick Elementary School
Cupertino, California, 95014
About this study
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.
Read the 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.
- Conditions
- Sunburn, Skin Cancer Prevention
- Being tested
- "I wear sunscreen everyday" song-based video
- Keywords
- Sunscreen, Sun protection, Education, skin cancer, school-aged children, prevention
- Medical subject headings
- Sunburn, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"I wear sunscreen everyday" song-based videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended intervention | Active comparator | 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. Receives: Behavioral: "I wear sunscreen everyday" song-based video |
| Maintenance | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)
Secondary outcomes (4)
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).
Measured: Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)
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.
Measured: Posttreatment (Time 2; up to 15 minutes)
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.
Measured: Posttreatment (Time 2; up to 15 minutes)
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.
Measured: Posttreatment (Time 2; up to 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start25 Feb 2019
- Primary completion11 Apr 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SunburnStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin M. Nord, Stanford University
- Investigators
- Kristin Nord, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752736
- Sponsor's protocol ID
- 46831
- Status last verified
- Aug 2019
- First submitted
- 16 Oct 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee GH, Bae GH, Barnes LA, Pol-Rodriguez MM, Ransohoff KJ, Nord KM, Lu Y, Cannell B, Weitlauf JC. The Sunscreen for Kindergarteners (SKIN) Study trial protocol. Contemp Clin Trials. 2021 Aug;107:106480. doi: 10.1016/j.cct.2021.106480. Epub 2021 Jun 11.
PubMed 34126263
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Safety Skills for Elementary School Students
- ClinicalTrials.gov ID
- NCT03752736
- Acronym / sponsor ID
- 46831
- Conditions
- Sunburn, Skin Cancer Prevention
- Keywords
- Sunscreen, Sun protection, Education, skin cancer, school-aged children, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended intervention | Active comparator | Behavioral: "I wear sunscreen everyday" song-based videoUpon 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. |
| Maintenance | No intervention | –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. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- General education Kinder students (Sedgwick Elementary School in 2018-2019).
- Child assent and parental consent are required to participate.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "I wear sunscreen everyday" song-based videoAll 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. | Behavioural | Extended intervention |
Primary outcome
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)
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.
4 secondary outcomes
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)
Teacher, parent and administrator perceptions of intervention utility.
Time frame: Posttreatment (Time 2; up to 15 minutes)
Teacher, parent and administrator perceptions of intervention value.
Time frame: Posttreatment (Time 2; up to 15 minutes)
Student perceptions of intervention likability
Time frame: Posttreatment (Time 2; up to 15 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 34126263Lee GH, Bae GH, Barnes LA, Pol-Rodriguez MM, Ransohoff KJ, Nord KM, Lu Y, Cannell B, Weitlauf JC. The Sunscreen for Kindergarteners (SKIN) Study trial protocol. Contemp Clin Trials. 2021 Aug;107:106480. doi: 10.1016/j.cct.2021.106480. Epub 2021 Jun 11.
- Individual participant dataSharing planned: No
Related trials for Sunburn
Not yet recruiting
Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
Active, not recruitingPhase 3
Undergraduate Skin Cancer Prevention Trial
Skin Cancer
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Nord, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "I wear sunscreen everyday" song-based video in people with Sunburn and Skin Cancer Prevention, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.