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Do novel interventions improve sunscreen concentrations for young children?

The effect of novel interventions on the thickness of sunscreen application amongst young children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001496202
Acronym
The Sunscreen And Young Children (SAY) Study
Enrollment
120
Registered
2018-09-05
Start date
2018-09-06
Completion date
2019-05-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this randomised intervention study will be to see if the amount of sunscreen applied to young children will improve with novel interventions, involving either daily personalised text messages or the daily use of stickers that change colour when sunscreen needs to be reapplied. This study will also look at the beliefs and attitudes relating to the use of sunscreen and other sun protective behaviours in young children. In addition, the study will also look at barriers to the use of sunscreen and other sun protective behaviours in young children and will measure the amount of photoaging at the commencement of the study. The study will involve online baseline questionnaire with the 1st visit to IHBI (Institute of Health and Biomedical Innovation) at QUT Kelvin Grove, Brisbane, Queensland, Australia. Followed up one week later by an online follow up questionnaire with a 2nd visit to IHBI. Followed up by a final online follow up questionnaire 3 months after the baseline.. Randomised into Control Group (participant takes tube of sunscreen home to use as usual), Intervention Group 1: Personalised Text Group (participant takes tube of sunscreen home to use AND receives personalised text message intervention each morning) or Intervention Group 2: Suncayr Stickers Group (participant takes tube of sunscreen home to use AND take Suncayr stickers to use).

Interventions

The purpose of this randomised intervention study will be to see if the amount of sunscreen applied to young children will improve with novel interventions. The intervention will involve either daily personalised text messages or the daily use of stickers that change colour when sunscreen needs to be reapplied. The amount of sunscreen applied to young children both before and after an intervention. The PICO (Problems Interventions, Comparisons & Outcomes) question statement is 'For young chil

The purpose of this randomised intervention study will be to see if the amount of sunscreen applied to young children will improve with novel interventions. The intervention will involve either daily personalised text messages or the daily use of stickers that change colour when sunscreen needs to be reapplied. The amount of sunscreen applied to young children both before and after an intervention. The PICO (Problems Interventions, Comparisons & Outcomes) question statement is 'For young children, does the use of Suncayr stickers or daily text message reminders, compared to those who use neither, improve the amount of sunscreen applied. This study will also look at the beliefs and attitudes relating to the use of sunscreen and other sun protective behaviour in young children. In addition, the study will also look at barriers to the use of sunscreen and other sun protective behaviours in young children and will measure the amount of photoaging at the commencement of the study. VISIT 1 TO IHBI: Commencement of SAY: Study • Participant information • Complete Consent Questionnaire online (at computer in room) and in written form, PhD Student Researcher to obtain the informed written consent at the commencement of the study. • Complete Eligibility online (at computer in room)• Patch test sunscreen for young child 10-15 minutes before sunscreen application • Complete Baseline Questionnaire (on computer in room or on smart phone or home computer) • Patch-testing of sunscreen and Suncayr sticker • Baseline measurements of existing sunscreen on skin (before sunscreen application) • Clean skin on both arms • Baseline measurement of sunscreen use – child apply to one arm and parent/caregiver apply to other arm, swabbing 3 times for each arm • Questions to determine interrupters to using sunscreen (so can address the interrupters with tailored text message response) • Photograph of hand/forearm of child (to enable photoaging) • Check for adverse events Randomised into Intervention Group 1: Personalised Text Group • Participant takes tube of SPF 50+ sunscreen home to use AND receives personalised text message intervention each morning for 7 days. The text messages will be personalised for each participant based on their risk, as assess by answers given for key baseline questionnaire questions. Randomised into intervention Group 2: Suncayr Stickers Group • Participant takes tube of SPF 50+ sunscreen home to use AND take Suncayr stickers to use each day for 7 days. The stickers will be applied one a day by the child and/or their parent/guardian to the child on their skin, ideally on the back of their hand or forearm. Participants will be asked to come into IHBI at QUT Kelvin Grove on 2 separate occasions, 1 week apart. On the first visit, 3 alcohol swabs will be wiped across the back of the arm of the young participant (over a designated surface area) and will be later analysed to determine the amount of sunscreen already on the skin of the young child when they came in. The 3 separate alcohol swabs will act as duplicates to promote data quality. Those will act as baseline measurements. If they had already applied sunscreen or moisturiser, they will be asked to wash their hands and arms with soapy water and dry. The young child will patch test some of the sunscreen QUT will provide for the study on their inner arm, as well as a small portion of the Suncayr sticker on their inner arm. After 10 minutes, if there is no adverse reaction to the sunscreen or Suncayr sticker, then the young child will apply sunscreen to one of their arms and their parent/guardian will apply sunscreen to their other arm. The Patch Testing form will be completed after patch testing and before study participation. The young child will apply sunscreen to one arm and their parent/guardian will apply sunscreen to their other arm. Then each arm will be swabbed with 3 fresh alcohol swabs and later analysed to determine the amount of sunscreen applied by both the young child and their parent/guardian. There may be some redness from the suction pressure of the sticker, this is normal. Participants will also complete a baseline questionnaire. After the baseline and initial measurements, participants will be randomised into one of 3 groups; a control group, an intervention group involving the use of Suncayr stickers and an intervention group involving daily text message reminders. On the second visit, 3 alcohol swabs will be wiped across the back of the arm of the young participant (over a designated surface area) and will be later analysed to determine the amount of sunscreen already on the skin of the young child when they came in. That will act as a baseline measurement. If they had already applied sunscreen or moisturizer, they will be asked to wash their hands and arms with soapy water and dry. The young child will apply sunscreen to one arm and their parent/guardian will apply sunscreen to their other arm. Then each arm will be swabbed with 3 fresh alcohol swabs and later analysed to determine the amount of sunscreen applied by both the young child and their parent/guardian. Participants will also complete a 1 week post-intervention questionnaire for the group to which they were assigned (control, text message or sticker). Participants will also complete a 3 month post-intervention questionnaire for the group to which they were assigned (control, text message or sticker). Questionnaire data will be recorded through RedCap and participant ID will be issued. Those participant ID from RedCap will then be used for any other data matching and follow up, such as in Excel. Intervention adherence will only be assed in the follow up questionnaire when participants will be asked if they used the stickers supplied or read the text messages sent.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

18+ males and females who are the parents/guardians of a child aged 2-6 years old. And Young children aged 2-6 years old

Exclusion criteria

Allergic to sunscreen

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026