EDiTS Study

You have been invited to take part in the preschool phase of the EDiTS Study because you have a child aged between 3 years 0 months and 5 years 11 months who is either developing typically or has a confirmed diagnosis of TSC. You must be at least 16 years old to participate, and able to understand and communicate in English.

No. If you consented to be contacted again when taking part in the infant phase of the study, we will be directly in contact with you to ask whether you would like to participate in this phase. However, participation in the preschool follow-up is completely voluntary and choosing not to take part will not disadvantage you or your child in any way.

Yes, in order to participate in the preschool phase of the study we will need to visit you and your child on one occasion when your child is between the ages of 3 years 0 months and 5 years 11 months. Using home-based assessments means that families do not have to travel anywhere to participate, which we feel provides a more flexible and accessible approach. We will do our best to make participation as easy as possible by offering visits during weekends and in the evenings. Assessments can be interrupted to meet the families’ needs and parents can stop them at any time for any reason. If you prefer, we can complete some of the assessments remotely via video call.

It is likely that we will be living with some Covid-19 restrictions for some time, so researchers will adhere to the following precautions in line with government guidelines and King’s College London protocols. Prior to the home visit, families will be asked to complete a brief Covid-19 screening questionnaire to identify any potential increased risk of exposure to the virus and to determine whether it is safe for a home visit to take place. During the testing phase, all researchers will undergo bi-weekly lateral flow tests to confirm that they have a negative Covid-19 test result before entering families’ homes. Whilst testing, researchers and participants will be asked to maintain social distancing where possible and wear personal protective equipment (PPE; face mask, shields, and gloves). Good hand and surface hygiene will be practised by the researchers and participants, including regular hand washing/sanitising and using antibacterial wipes to clean any equipment. Following the home visit, researchers will rely on the NHS Track and Trace system to be alerted to any potential exposure to the virus. Please note: Vulnerable families (defined in line with government guidelines at the time of data collection) will be asked not to host home visits in order to minimise their risk of infection. Instead, these families will be asked to complete the priority-ordered minimal assessment protocol remotely where possible, such as parent-report questionnaires and interviews conducted via video call.