Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001496202
Ethics application status
Approved
Date submitted
3/09/2018
Date registered
5/09/2018
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do novel interventions improve sunscreen concentrations for young children?
Scientific title
The effect of novel interventions on the thickness of sunscreen application amongst young children
Secondary ID [1] 295973 0
NIL
Universal Trial Number (UTN)
Trial acronym
The Sunscreen And Young Children (SAY) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 309483 0
sun exposure 309484 0
Condition category
Condition code
Skin 308317 308317 0 0
Other skin conditions
Public Health 308318 308318 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312302 0
Prevention
Intervention code [2] 312331 0
Behaviour
Comparator / control treatment
Randomised into control group:
• Participant takes tube of SPF 50+ sunscreen home to use on the child as they normally would for 7 days, so the sunscreen could be applied by the child and/or the parent to the child.
Control group
Active

Outcomes
Primary outcome [1] 307295 0
Change from baseline in the amount of sunscreen applied to the child by will be measured using the alcohol swab technique. The young child will apply sunscreen to one of their arms and their parent/guardian will apply sunscreen to the other arm. Control, text message intervention and sticker intervention groups to be compared.
Timepoint [1] 307295 0
7 days (1 week).
Secondary outcome [1] 351421 0
Changes from baseline in the beliefs and attitudes relating to the use of sunscreen as assessed by the baseline questionnaire, 1 week follow up questionnaire and 3 month follow up questionnaire.

The majority of questions in the questionnaires have come from the following sources:
• Hamilton, A. (2011). Sunscreen application thickness amongst primary school children : the children and sunscreen study. Retrieved May 1, 2016, from QUT ePrints, https://eprints.qut.edu.au/49039/
• Kester, B., Sondergaard, J., Nielsen J. B., Allen, M., Olsen, A., & Bentzen, J. (2017). The validated sun exposure questionnaire: association of objective and subjective measures of sun exposure in a Danish population-based sample. The British Journal of Dermatology, 176(2), 446-456.
• Brodie, A. M., Lucas, R. M., Harrison, S. L., van der Mei, I. A., Armstrong, B., Kricker, A>, Mason, R. S., McMichael, A. J., Nowak, M., Whiteman, D. C. & Kimlin, M. G. (2013). The AusD Study: a population-based study of the determinants of serum 25-hydroxyvitamin D concentration across a broad latitude range. American Journal of Epidemiology, 177 (9), 894-903.
• Autier, P., Dore, J. F., Cattaruzza, M. S., Renard, F., Luther, H., Gentiloni-Silverj, F., Zantedeschi, E., Mezzetti, M., Monjaud, I., Andry, M., Osborn, J. F. & Grivegnee, A. R. Sunscreen use, wearing clothes, and number of nevi in 6- to 7-year-old Europen children. European Organization for Research and Treatment of Cancer Melanoma Cooperative Group. Journal of the National Cancer Institute, 90(24), 1873-1880.

In addition, some new study-specific questions were generated. The SAY pilot study investigated the acceptability and face validity of these questions and found them acceptable to the participants and clear to understand.

All sourced questions had been previously validated. Any original questions were validated by face validity with participants of the SAY pilot study, which was not a clinical trial.
Timepoint [1] 351421 0
7 days (1 week) and 3 months.

Eligibility
Key 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
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergic to sunscreen

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and statistical or power issues:
Sample size will be 40 per group (so 120 total) to allow for a loss to follow up, with a statistical power of 0.8.

o Data from the baseline will be linked to the data collected in the 1 week follow up to allow for t-tests and paired t-tests. ANOVA analysis will be used to compare the different intervention groups. If there is a difference between the 3 groups (control, sticker and text messages), this study will firstly look at the amount difference in sunscreen application (mg/m2) and the % change from the baseline sunscreen measurement. This study will also analyse to see if there is a change in parent/guardian application from follow up compared to baseline, and also if there is a change in young child application from follow up compared to baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2018
Actual
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23856 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 300569 0
University
Name [1] 300569 0
Queensland University of Technology
Country [1] 300569 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue,
Kelvin Grove,
Qld 4059
Country
Australia
Secondary sponsor category [1] 300062 0
None
Name [1] 300062 0
NIL
Address [1] 300062 0
NIL
Country [1] 300062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301359 0
Queensland University of Technology - The University Human Research Ethics Committee (UHREC)
Ethics committee address [1] 301359 0
Ethics committee country [1] 301359 0
Australia
Date submitted for ethics approval [1] 301359 0
Approval date [1] 301359 0
22/01/2018
Ethics approval number [1] 301359 0
1700001103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86738 0
Mrs Helen Ford
Address 86738 0
Queensland University of Technology,
Institute of Health and Biomedical Innovation (IHBI),
60 Musk Avenue,
Kelvin Grove,
QLD 4059
Country 86738 0
Australia
Phone 86738 0
+61 7 3138 0622
Fax 86738 0
Email 86738 0
[email protected]
Contact person for public queries
Name 86739 0
Helen Ford
Address 86739 0
Queensland University of Technology,
Institute of Health and Biomedical Innovation (IHBI),
60 Musk Avenue,
Kelvin Grove,
QLD 4059
Country 86739 0
Australia
Phone 86739 0
+61 7 3138 0622
Fax 86739 0
Email 86739 0
[email protected]
Contact person for scientific queries
Name 86740 0
Helen Ford
Address 86740 0
Queensland University of Technology,
Institute of Health and Biomedical Innovation (IHBI),
60 Musk Avenue,
Kelvin Grove,
QLD 4059
Country 86740 0
Australia
Phone 86740 0
+61 7 3138 0622
Fax 86740 0
Email 86740 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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