Parent-implemented therapy on language development in deaf children with cochlear implants Ear, Nose and Throat
Conditions
Interventions
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
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children: 1. Aged less than 5 years old at time of 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Receptive language development is assessed using the Auditory Comprehension subscale of the Preschool Language Scale – Fifth Edition PLS-5 UK at baseline and 12-months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Receptive language development - measured by the PLS-5 Auditory comprehension subscale at 6 months post randomisation 2. Expressive language development - measured by the PLS-5 Expressive communication subscale at baseline, 6-months and 12-months post randomisation 3. Childhood developmental milestones - measured by the Schedule of Growing Skills questionnaire (SGS) at baseline and 12-months post-randomisation 4. Child Behaviour measured by the Strengths and Difficulties Questionnaire (SDQ) at baseline and 12-months post-randomisation 5. Social emotional functioning measured by the Ages and Stages Questionnaire: Social Emotional – 2 (ASQ:SE-2) at baseline and 12-months post-randomisation 6. Pragmatic language development measured using the Language Use Inventory (LUI) at baseline and 12-months post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactLouise Nicholson-Scott
Outcome results
None listed