IMPACT (IMplemented by Parents And Carers Therapy) trial: A multicentre randomised controlled trial to evaluate the efficacy of a parent-implemented therapy on language development in deaf children with cochlear implants
Parent-implemented therapy on language development in deaf children with cochlear implants
This trial aims to find out whether a parent-led programme called "It Takes Two to Talk" (ITTT) can help young children with cochlear implants (CIs) develop better language skills than they would with standard care alone. The children in this study are under 5 years old and have recently had their cochlear implants activated. Parents play an important role in language development, and ITTT trains them to use specific strategies during everyday interactions to support their child’s communication. In the trial, some families will take part in the ITTT programme in addition to receiving standard NHS care. Other families will receive only the standard care currently offered to children with CIs. We will compare the children’s ability to understand spoken language (receptive language) after 12 months to see if ITTT provides additional benefits. Intervention: Parents in the ITTT group will complete a 3–4-month online programme, including group sessions and individual coaching from a trained speech and language therapist, to learn how to help their child develop language skills. Comparator: Families in the control group will continue with the standard care provided for children with CIs, such as appointments with audiologists and speech therapists. Children will be assessed at baseline - before their cochlear implant surgery and at 6 and 12 months after randomisation. The assessments will include assessments completed by the clinical team at the CI centres and questionnaires that are completed by the families. The primary outcome will be measured at 12 months, by the clinical sites, because research suggests that this is when the benefits of ITTT are likely to be most noticeable. We will also look at other factors, such as children’s expressive language, child behaviour, emotional and social development, and developmental milestones. This design will help us understand whether ITTT is an effective and practical way to improve language development in children with coch
Children: 1. Aged less than 5 years old at time of cochlear implant (CI) surgery 2. Meets UK NICE criteria for bilateral cochlear implantation 3. Bilateral cochlear implants with full electrode insertion in both ears 4. History, examination and pre-operative imaging suggests a structurally normal and fully patent cochlea with normal cochlear nerves bilaterally Parents: 1. Capable of understanding and speaking English 2. Ability to provide informed consent NB: Parents will be recruited and consented once the child’s CI implantation surgery has been confirmed. Prior to randomisation, eligibility criteria in relation to CI surgery will be assessed and children not meeting the criteria will not be randomised into the trial.
Children: 1. Incomplete electrode insertion in one or both ears 2. Developmental disorders known to impact on CI outcome including but not limited to brain injury, brain tumour, Down syndrome, and fragile X syndrome 3. English not the dominant spoken language at home (including British Sign Language (BSL)) 4. Structural brain malformation, severely malformed cochlea, Auditory Neuropathy Spectrum Disorder, cochlear nerve deficiency and/or post-meningitis deafness 5. Any known factor that may restrict full insertion of the electrode array 6. Participation in any other CI intervention clinical trial Parents 1. English not the dominant spoken language at home (including BSL)