Title: Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE)
Funder: Department of Health and Social Care

Abstract: Background: Children with autism spectrum disorder (ASD) are especially vulnerable to isolation as they struggle to establish and maintain friendships due to the social and communication impairments characteristic of the disorder. The most common intervention for this is social skills training but studies indicate that while these children may learn to demonstrate appropriate social skills within the setting of the intervention, applying these new skills to their everyday life is often unsuccessful. LEGO-based therapy is a social development program for children and was developed as a means of addressing the limitations of more generic social skills groups through the use of an intrinsically motivating task. Objectives: The primary objective is to examine the clinical effectiveness of LEGO-based therapy groups on the social and emotional competence of children with ASD within the school setting. Secondary objectives are to examine the perceived social isolation, health effects, and cost-effectiveness of LEGO-based therapy on the participating child. Design: The proposed trial is a cluster randomised controlled trial comparing LEGO-based therapy groups and usual care with a control group receiving just usual care. There will be an internal pilot study which will run for 10 months to examine the feasibility of recruitment. At 10 months we expect to have recruited 120 participants, of which one third (n=40) will have reached the primary endpoint. Stop/Go criteria based on 75% of recruitment target and 70% of outcome measures will be used to assess feasibility of continuing the trial. There will be a nested qualitative, acceptability and fidelity components and an economic evaluation. Setting: The intervention will be delivered by an assigned school teaching assistant (TA) trained by a member of the research team within the participants’ schools. Participants: We will recruit 240 participants. Each participating child will have a diagnosis of ASD, will be aged between 7 and 15 years old, and attend a mainstream school. The child’s parent/guardian and associated teacher/TA will also participate to aid in outcome assessment. Interventions: Participating children allocated to the intervention group will be invited to attend a weekly LEGO-based therapy group for a period of 12 weeks and will also access their usual care. Participants allocated to the control group will continue to access their usual care and will not receive the intervention or any extra support services from the research team. Main outcome measures: The primary outcome measure will be the Social Skills Improvement System (SSIS) completed on behalf of the child by the participating teacher/TA. Secondary measures will include the Multidimensional Scale of Perceived Social Support, the Asher Loneliness Scale, the EQ-5D proxy (5L version), the Child Health Utility 9D (CHU-9D) and bespoke resource use and acceptability questionnaires. Analysis: The statistical analysis will use a generalised linear mixed model framework to compare the mean outcome measure in cases and controls adjusted for baseline measurements and other key covariates (such as age and sex). Intention to treat analyses will be conducted on all outcome measures.

Lay abstract: It is estimated that approximately 1.6% of people in the UK have autism spectrum disorder (ASD) which causes difficulties with social interaction, communication, behaviour, and interests. Such difficulties often cause problems in day to day life and often result in the child feeling socially isolated. The most common treatment for this is social skills training but while these children may learn to demonstrate appropriate social skills within the setting of the intervention, applying these new skills to their everyday life is often unsuccessful. LEGO-based therapy is a new approach that is specifically designed to make social interactions interesting to the child with ASD so that they will not only learn the necessary skills but adopt them in their daily lives. The main aim of this research is to examine whether LEGO-based therapy groups in schools has any impact on the social and emotional competence of children with ASD. The research also aims to look at the child’s perceived social isolation and any changes in the mental and more general health of the child resulting from LEGO-based therapy. The therapy will be delivered by an assigned school teaching assistant (TA) within the child’s school. Children allocated to the intervention group will be invited to attend a weekly LEGO-based therapy group once a week for 12 weeks. In order to do this we will recruit 240 children with ASD aged between 7 and 15 years old, their parent/guardian and a teacher/TA at their school. We will randomly allocate people to either attend a LEGO-based therapy group or to access usual care which includes support from their GPs, mental health and education professionals. The children who will attend the LEGO-based therapy group will also continue to access their usual care. The Social Skills Improvement System (SSIS) will be completed on behalf of each child (in both groups) by teachers and change in these scores will be the main consideration of this research. We will also ask the children, their parent/guardian, and their teachers to complete other questionnaires to assess the child’s mental and general health, and also their quality of life. All these measures will be completed as soon as the participating child and their parent/guardian agrees to take part in the research, and also at 16 and 52 weeks after this point. This will enable us to see whether LEGO-based therapy makes any difference compared to usual care and whether any differences last into the next school year. We will also interview a small number of participants about the acceptability of the intervention. In planning our research we have approached various people for advice. The National Autistic Society (NAS) helped with the design and will continue to advise as we carry out the research, particularly in providing the perspective of people with autism. A parent of a child with autism and teaching assistant has helped us understand the research priorities and the appropriateness of the intervention. The 'Young Dynamo's Research Group' is made up of young people aged 14-19 and have also provided views on the suitability of the intervention especially for those new to LEGO. Additionally, to help us understand aspects of the research in the school environment we have involved a teaching assistant who has many years’ experience in working with children with autism in a school environment and has also been trained in the delivery of LEGO-based therapy.

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