About the study

What is Involved?

You and your child are being invited to participate in this study because your child has eczema. To participate you need to be the parent of a child aged 2-10 years with eczema, and aged 18 years or over. You will complete a telephone assessment of approximately 10 minutes duration to make sure this version of Triple P is suitable for you.

If you agree to be in the study, we will send you out a pack of research materials, and a member of the research team will have a short (10-15 minute) Zoom (videoconference) or phone call with you on 4 separate occasions over a 4-month period: on enrolment into the trial (Call 1), before starting Triple P (Call 2), 4 weeks after finishing the program (Call 3), and 3 months after finishing the program (Call 4).

• During Call 1, the researcher will talk you through setting up your child’s usual eczema creams with specially-designed electronic caps that monitor when and how often they are used. They will also help you to record the different creams and ointments that your child uses, so that we can keep track of how much you use during the study. Finally, they will help you to take a set of photos of your child’s skin and upload them to the research team using a secure portal. Our nurses will use the photos to assess the severity of your child’s eczema.
• During Call 2, the researcher will talk you through weighing and recording your child’s creams and ointments. They will also ask you to take a second set of photos of your child’s skin. They will then randomly allocate your family to one of two groups: Start Now Triple P or Start Later Triple P.
• Parents allocated to the Start Now group will receive access to the online program straight after Call 2. This involves logging on to an online portal (EdX) and completing the Positive Parenting for Healthy Living Triple P modules over a 2-week period.
• During Calls 3 and 4, the researcher will once again ask you to weigh and record your child’s creams and ointments, and ask you to take another set of photos of your child’s skin.
• If you are allocated to the Start Later group, you will be required to wait 4 months from when you enrolled in the study before receiving access to Healthy Living Triple P.

Parents will also be asked to complete 3 sets of online questionnaires about their child, their experiences managing their child’s eczema, and their parenting experiences. These will be sent to you via email before Calls 2, 3, and 4, and will take approximately 30 minutes for you to complete.

To check how your child’s skin is going in between calls, we will also ask you to send us one (1) photo of your child’s worst patch of eczema on the same day each week that you are in the study.

Lastly, we will ask your permission to contact your child’s doctor, to gain details of your child’s diagnosis and any medications or treatments that are currently prescribed for your child.

What if I wish to withdraw from the research project?

Your decision whether or not to participate will not prejudice your or your child’s future relations with Children’s Health Queensland. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time. The decision to withdraw from the study will not affect your child’s routine medical treatment or their relationship with the people treating them.

What are the possible benefits for me, my child, and other people in the future?

We have previously tested this program with parents of children with eczema using a face-to-face group-delivered format, and it had positive effects on child behavior, parents’ confidence with eczema management, and children’s eczema symptoms (as reported by parents). This study will help us to find out whether providing the same program using a self-directed online format can also improve outcomes for children and families and may help us to improve the care we can offer families in the future.

What are the possible risks, side-effects, discomforts and/or inconveniences?

Your participation in this study should involve no physical or mental discomfort, and no risks beyond those of everyday living. If, however, you should find any question or procedure to be invasive or offensive, you are free to omit answering or participating in that aspect of the study.

Some children may feel a little embarrassed or shy when you are taking their photos. If this happens, please just let us know and we will work with you to find a way to help your child feel more comfortable. If your child is unwilling to participate in any aspect of the study they will not be pressured to do so, and we will respect their decision.

What will be done to make sure your information is confidential?

To ensure confidentiality all records will be kept in locked cabinets at the Parenting and Family Support Centre, University of Queensland. The information in this study will only be used in ways that will not reveal who you are. You will not be identified in any publication from this study or in any data files shared with other researchers. All information provided will be held in strict confidence, and will be used for statistical purposes only. Confidentiality will only be breached if a child is deemed at risk of harm. Data collected from you or your child will be de-identified, by replacing any identifying information (e.g. your name) with a participant number. Identified or de-identified research data may be made available for review by ethics review committees, the funding body (Children’s Hospital Foundation), the clinical trials monitor, or other regulatory authorities, for the purposes of monitoring the ethical and scientific conduct of the study.