Title: Evaluating ‘Enhancing Pragmatic LAnguage skills for Young children with Social communication impairment’ (E-PLAYS): A feasibility study
Funder: Department of Health and Social Care

Abstract: Background Social Communication Disorder Social (pragmatic) communication disorder (SCD, DSM-5, 2013 [7) affects around 7.5% of children [8] and overlaps with autism and other language disorders. Children with SCD struggle with communication in social contexts and experience high levels of mental health disorders. SCD impacts on social development resulting in heightened risk of bullying, disruptive behaviour, isolation and school exclusion [8 &ndash; 16]. Language disorders have a similar prevalence and impact to ADHD, dyslexia and childhood obesity, but have attracted substantially less research funding [17, 18, 53]. Consequently, there exist few evidence-based, cost-effective interventions. Existing interventions Only one intervention for children with SCD has been subject to a randomised controlled trial [21, 24]. This is designed to be delivered by specialists i.e., speech and language therapists (SLTs) [23, 56]. No rigorously-tested interventions are available for delivery by non-specialists such as teaching assistants who frequently work with children with SCD in collaboration with SLTs. We propose here an intervention which: (a) Could be used by non-specialist teaching assistants with input from SLTs; (b) Adopts a novel, computerised-script approach to support learning via collaboration with other children; (c) Harnesses computer technology to introduce fun and appealing, motivating features. Pilot work A limited number [25, 29-40] of computer games have been designed to support and facilitate collaboration between children with communication difficulties. However, none have yet been subject to rigorous testing, and none have produced games ready for large-scale evaluation; most are at prototype stage. By contrast, a pilot RCT by our team [1,12] has shown that our Enhancing Pragmatic LAnguage skills for Young children with Social communication disorder (E-PLAYS) computer game intervention produced significant improvements in communication and enjoyment of social interaction by children with SCD. Aims Evaluation of E-PLAYS in an NHS setting In our pilot study, E-PLAYS was delivered by research assistants, trained and supervised by the university research team. We now wish to test the implementation of E-PLAYS in the NHS, delivered by teaching assistants trained and supervised by NHS SLTs. Delivery of E-PLAYS in this setting, with different personnel, is likely to bring to light a different set of challenges than those in our pilot. We are proposing, in this application, to undertake a feasibility study at this stage to assess the viability of a future full-scale RCT. The feasibility study will investigate, among other factors, recruitment, data collection, procedures and estimates for sample size. Plan of investigation Feasibility cluster-randomised controlled trial of E-PLAYS intervention Children with SCD will be randomised to an intervention group who will receive E-PLAYS, versus a control group receiving treatment as usual. Outcome measures Blinded measures of language and communication will be taken together with parent-completed measures of health service use and teacher-completed measures of peer relations and communication. Process evaluation As well as measuring outcomes, we will examine the processes involved in delivery of E-PLAYS in an NHS setting, so as to understand challenges involved in implementation. We will use qualitative methods to investigate in-depth the views of the children, SLTs and teaching assistants involved. In brief, strengths of this application are: It aims to test a much-needed intervention for a group of children with a condition that has received little public attention or research funding [17, 18] It adopts a novel approach to intervention, harnessing computer technology for child-appeal and cost-effectiveness A pilot study has shown promising preliminary evidence and significant results The project will be led by a multi-disciplinary team, with extensive research experience and excellent knowledge of NIHR-relevant methodology. The team will benefit from the support of a well-established clinical trials unit specialising in trials with young children.

Lay abstract: Background Children with social communication impairments struggle to communicate appropriately in social contexts; for example, they misinterpret non-literal language and ignore turn-taking and social conventions. Impairments in social communication have profound effects on children s social development, mental health, and education and are strongly associated with bullying, isolation and school exclusion. There is a lack of evidence-based, cost-effective interventions for children with impairments in social communication. We have developed a novel approach Enhancing Pragmatic Language skills for Young children with Social communication disorder (E-PLAYS) using a fun computer game; E-PLAYS is for children 4-7 years-old, attending mainstream schools. A pilot study by our team showed significant improvements on a communication test and enjoyment of social interaction by children who received E-PLAYS compared to a group who did not receive E-PLAYS when this was delivered by university-trained post-graduate research assistants. Aims We want to run a large trial to find out whether E-PLAYS could be delivered effectively by NHS speech and language therapists working with school teaching assistants instead of being delivered (as in our pilot study) by university-trained research assistants. We will first run a small feasibility study to see: Whether we could recruit enough speech and language therapists and children from NHS trusts for a full-sized trial, how acceptable they find E-PLAYS and gather information on how best to run a full trial. Patient and public involvement Gamers, teachers, speech and language therapists and children helped us to develop E-PLAYS, and young people with communication disorders gave feedback. Speech and language therapists, parents, young people with social communication impairments and I CAN (the UK s largest communication charity) directors have joined our advisory group to collaborate on the project with us.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH