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.

Research question: Can a parent-implemented therapy called “It Takes Two to Talk” (ITTT), in addition to standard NHS care, improve language development in deaf children with cochlear implants (CIs)? Background: Most children‡ benefit from CIs, but some are slow to develop language and struggle academically. Parents significantly influence language development but are often overlooked in existing CI rehabilitation models. Evidence supports the use of parent-implemented therapy, including ITTT, to improve language development in normally-hearing children. Preliminary evidence also supports its use in children with CIs. Aims and objectives: This trial aims to evaluate the efficacy of ITTT as an adjunctive therapy to standard care on language development in children with CIs. The objectives are to compare 1) receptive language development between children with CIs who receive ITTT as an adjunctive therapy, with controls who receive standard care alone, and 2) parent-child interactions, expressive language, child behaviour, social-emotional functioning, and developmental milestones between both groups. Methods: 158 children <5 years old who had CIs activated in the previous 2 months will be recruited from 10 UK clinics for a multicentre, parallel group, randomised-controlled trial. Randomisation will allocate the child to either receive standard NHS care in addition to their parent(s) participating in the ITTT program, or standard care alone. Randomisation will be on a 1:1 ratio using random permuted blocks of varying size. Children will be assessed at baseline, 6 and 12 months after randomisation, with the primary outcome being receptive language development at 12 months measured using the PLS-5 UK administered by a blinded assessor, when effects of having received ITTT should be maximal. We hypothesise that children of families who receive ITTT will have better language skills than those who do not. We will also assess whether ITTT training influences a child’s interactions with their parents, their behavioral, emotional and social growth, and their developmental milestones. Whilst non-English speaking families will be excluded from the trial, additional research will be conducted to explore the effective inclusion of these families in the ITTT program. Timelines for delivery: 60-month trial starting on 1st June 2024, with a 12-month internal pilot. Anticipated impact and dissemination: Results from this trial will be shared via scientific conferences, high-impact peer-review publications, newsletters, and the media. Robust evidence that ITTT benefits language development in children with CIs, will lead to a future trial to assess the longer-term effectiveness and cost-effectiveness of this therapy. Since this result may impact on the future support needs and educational outcomes of these children, it could lead to significant cost savings for the NHS and educators.