Background

Research shows that children with cochlear implants have varying speech and language skills, influenced by factors like the cause of their hearing loss and how long they've been deaf. Another factor is how well the parents/carers are interacting and communicating with the child.

The IMPACT trial will test, if training parents to communicate better with their children using a program called "It Takes Two to Talk" (ITTT) can improve their speech and language skills after a CI. Furthermore, in addition to the usual NHS care, we will use the ITTT programme. In the ITTT programme parents will learn how to understand their child’s communication style, work with a speech therapist to set goals, and find ways to motivate and encourage their child to communicate. The program will also teach parents how to adjust everyday routines to help their child participate in conversations and support language development.

Who can take part in the study?

We are looking for children under the age of 5 years old who are due to receive cochlear implants and their parents/carers to take part in this trial.

If you are suitable and consent to the trial, what happens next?

As nobody knows which method helps language development the most, families will be placed into a group by chance, through a process called randomisation. Approximately one month after your child’s CI surgery you will be randomly placed into one of two groups:

1.    Standard Care Group: The child receives standard NHS care.

2.   Standard Care + ITTT Group: The child receives standard NHS care plus the parent(s) take part in the ITTT programme. ITTT will be delivered remotely.

Trial duration

The trial 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, and all families will have to attend *three appointments at their CI centre lasting around 2 hours per visit.

*Speech and language tests will take place before CI surgery, at 6 and 12-month visits (lasting approximately 2hours per visit).

As part of the trial, you will need to attend three visits to your CI centre, complete four questionnaires twice, and potentially take part in the ITTT programme. The four questionnaires that you will be sent to complete at home should take no more than 1 hour 30 minutes in total. 

It Takes Two To Talk (ITTT) programme

Parents/carers placed in the “Standard Care + ITTT Group” will complete the ITTT programme as part of the trial. ITTT is a parent/carer training programme developed by clinicians at the Hanen Centre in Toronto, Canada for parents/carers of children with language and communication delays. In the ITTT programme, parents/carers will learn how to recognise their child’s stage and style of communication, working with a speech and language therapist to identify next steps and set goals. 

The ITTT programme lasts for approximately 3-4 months, is delivered completely online and involves:

  • One initial pre-programme introduction session: A one-to-one meeting between the parent/carer and the speech and language therapist to discuss the programme and set expectations. During this session you will be asked to record a video of you and your child interacting together. The speech and language therapist will review the video with you, and it may be shared in the first group session, if you agree.
  • One group orientation session: The first group session where all the families are introduced and learn more about the programme and what’s involved.
  • Eight parent/carer group sessions: These sessions are for parents/carers only and are conducted in a group setting with other families participating in the trial.
  • Three individual sessions: Personalised sessions between the parent/carer and speech and language therapist. During these sessions, you may be asked to record a video of you and your child interacting together. The speech and language therapist will review the video with you.

All sessions will be held online and will last for approximately 1 to 2.5 hours each. We will provide you with any support you may need to access these sessions. The approximate time commitment for the whole ITTT course is 25-30 hours across the 13 sessions.

Follow up visits

Visit one: 6 months after you have been randomised either to the “Standard Care Group” or the “Standard Care + ITTT Group” you and your child will attend a visit at your CI centre. There, your child will complete one speech and language assessment lasting approximately 2 hours.

Visit two: 12 months after you have been randomised either to the “Standard Care Group” or the “Standard Care + ITTT Group” you and your child will attend a visit at your CI centre. There, your child will complete one speech and language assessment, lasting approximately 2 hours. Before the visit, we will send you four questionnaires to complete at home and return in the post to the NCTU trial team, these should take no more than one hour and a half.

The 12month visit marks the end of your participation in the trial. After this, you will not need to do anything further, and your child’s care will resume as normal at their CI centre.

Token of appreciation 

You will receive two vouchers totalling £45 as a token of appreciation for your participation.

How we use your information

Animated Explainer Videos 

The following video links are designed to supplement or provide an alternative format to explain core trial topics to participants.

Videos in English:

Videos in English with British Sign Language:

Videos in Welsh:

Frequently asked questions:

What are the possible benefits of taking part?
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.
 
What are the possible disadvantages or risks of taking part?
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.
 
What if there is a problem?
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  
 
What happens if I don't want to carry on in the trial?
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. 
 
Will I be paid for taking part in the trial?

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.

 
How will information about me and my child be used?

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.