Intensive Interaction for children and young people with profound and multiple learning disabilities: INTERACT trial

RESEARCH QUESTION What is the clinical and cost-effectiveness of Intensive Interaction (II) alongside standard practice for improving communication skills in children and young people with profound and multiple learning disabilities (PMLD)? SETTING Educational settings consisting of both special schools and mainstream schools with specialist facilities. BACKGROUND Children and young people with PMLD have difficulty communicating and typically rely on non-verbal methods of communication. II uses pre-verbal communication techniques to build a relationship between the person with PMLD and a communication partner with the view of improving communication skills. AIMS AND OBJECTIVES The aim is to undertake a cluster RCT comparing II and usual care with usual care alone in terms of communication skills. The objectives are to undertake a trial which will include an internal pilot an economic evaluation and process evaluation. METHODS A multi-setting pragmatic, two-arm, cluster-randomised superiority trial of an 18-week II programme versus usual care for children and young people with PMLD including an internal pilot, economic and process evaluations. Three hundred and thirty children and young people will be recruited from 66 educational settings. The intervention will be delivered at least once per day for at least 18 weeks by staff within educational settings and by parents/carers at home. Diaries will be kept to monitor the number of sessions taking place. Survey results have indicated that usual care will be highly variable both within and between educational settings. Quantitative and qualitative methods will be used to capture what usual care looks like for the children and young people included in our sample. Communication skills at 32 weeks is the primary outcome measure using the Communication Complexity Scale. Secondary outcomes will include: quality of life, education outcomes, social and emotional engagement, carers well-being, sense of competency and experience, challenging behaviour, adverse effects, social care outcomes, adherence to the intervention and cost-effectiveness. Data will be collected at baseline, 32 and 52 weeks from parents/carers and staff in the educational settings. The cost-effectiveness of II versus standard practice will be evaluated over a 12-month period using a within-trial cost-utility analysis. A mixed methods process evaluation will be undertaken to explore fidelity and acceptability of the INTERACT intervention throughout the trial. TIMELINES The trial will run for 52 months including set-up and an internal pilot during the first 18 months (to coincide with an academic year). Follow-up for the final year of recruitment will take place during months 45-46 leaving 6 months for analyses and report write-up. ANTICIPATED IMPACT AND DISSEMINATION If effective, the results could lead to a change in practice which would positively impact on children/young people with PMLD as well as their teaching staff and parents/caregivers. Results will be disseminated at conferences and published in open access journals. Dissemination activities will include bespoke outputs for personal and professional networks, social media and public engagement events.