If you agree for you and your child to participate in the trial, you will be asked to read and sign the informed consent form before your child’s CI surgery. Your participation in the study will last for up to 20 months depending on your child’s surgery time, after you have been placed into one of the two groups you will remain in the trial for 12 months. As part of the trial, you will need to attend three visits to your CI centre, complete three questionnaires twice, and potentially take part in the ITTT programme. We will do our best to schedule these visits at convenient times for you and will send reminders about upcoming appointments.

Taking part in the trial may not directly benefit you or your child. We expect that one of the benefits of this trial will be for others in the future. We hope the information we get will allow us and other researchers and clinicians to design and implement better rehabilitation programmes for CI children.

There are no risks associated with any of the activities you or your child will be undertaking as part of this trial. If you have any questions, please ask a member of the team, who will be able to discuss this with you.

If you have concerns or questions about any aspect of this trial, you should ask to speak to the local researchers. Alternatively, you can contact the trial coordinating centre via email: impactstudy@nottingham.ac.uk  

You are free to withdraw at any time, without giving any reason, and without any consequence to you or your child’s current or future treatment. If you would like to withdraw, contact your local researchers or NCTU trial team via email at: impactstudy@nottingham.ac.uk and they can inform you of the next steps. If you withdraw, we will no longer collect any information about you or from you, but the information collected up until that point will not be erased and this information may still be used in the project analysis. 

You will not receive payment for taking part in the trial.

You will receive a £20 voucher at the end of your 6-month visit and £25 voucher at the end of your last visit as a token of appreciation for your participation in the trial.

We will need to use information from you and your child for this research project. This information will include your child’s NHS number from their medical notes and your and your child’s name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. 

Your data will not be shared outside the UK. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. We will keep your study data for a maximum of 7 years. The study data will then be fully anonymised and securely archived or destroyed.