Title: Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): A randomised controlled trial and economic evaluation of a Social Stories intervention to address the social and emotional health of children with ASD in primary schools
Funder: Department of Health and Social Care

Abstract: Design: A pragmatic cluster randomised controlled trial examining the effectiveness and cost effectiveness of Social Stories for children with ASD and challenging behaviour daily. This design was drawn from the successful HTA feasibility study (ASSSIST). Setting: Primary schools across Yorkshire and Humberside. Target population: Children aged 4-11 in primary schools with a research diagnostic criteria diagnosis of ASD and daily challenging behaviour. Children who have used Social Stories in the last school term will be excluded. Health Technology Being Assessed: Social Stories are a story-based intervention written by a teacher (with parent and child where possible). The child is written into a story describing a social situation or behaviour targeting a goal (e.g. head banging). A training package and manual for Social Stories was developed during the feasibility study, with strong PPI (parents/teachers & young people with autism). Before randomisation, the parent & teacher/TA agree a target behaviour. Once allocated, they are trained to write and deliver tailored Social Stories for the child (intervention). The comparator arm will receive care as usual. Measurement of Costs and Outcomes: Completed at baseline, 6 weeks and 6 months (primary time-point). The primary outcome will measure social impairment using the validated Social Responsiveness Scale (SRS-2), contextualised with a goal based outcome measure. Secondary outcomes include: Revised Child Anxiety and Depression Scale, the EQ-5D-Y proxy & CHU 9D. Health/non-health costs will be gathered yielding an incremental cost-effectiveness ratio and probability of cost-effectiveness at willingness-to-pay thresholds. These outcomes had the highest completion rates in the feasibility work. 20% of the participants will be observed in class by a blinded research assistant to count targeted behaviours. Other measures include resource utilisation including education and NHS services, and a process evaluation. We will measure classroom attendance, parental stress, treatment preference and intervention sustainability. Sample size: The correlation between baseline and 6 weeks (r=0.67, 95% CI 0.44 to 0.80) was lower than that at 16 weeks (r=0.83, 95% CI 0.68 to 0.91) for the pilot data. We have been conservative and have chosen the lower 95% confidence limit for the lowest correlation between baseline and follow-up that we observed within our pilot data including both time points (r=0.44). We have also increased the sample size to account for a higher attrition rate (25%) at 6 months. In terms of the variability of the outcome measure for the later time points, we have found that the SD appears to be stable (<=7) across time points in the pilot data. The overall sample size is 278. Project Timetable including recruitment rate: The study duration of 42 months includes 6 month set-up, 24 month recruitment, 6 months follow up, and 6 months for analysis/dissemination. During the feasibility study, we averaged a recruitment rate of 4 children per month, in York only. By opening up this full scale trial to more than 4 times the area (the whole of Yorkshire and Humber), we are confident we can achieve recruitment of 11 per month. We will run an internal pilot of 10 months recruitment based around school recruitment with clear stop go criteria.

Lay abstract: Children with autism spectrum disorder (ASD) experience lots of stress about school life and social interactions. This may cause anxiety, distress, and challenging behaviour. This can lead to parent and teacher stress, and costly out of area placements for the child. This has a high emotional, personal and financial cost to children, families and services. Social Stories help children with ASD understand social situations. A Social Story writes the child into a story, and is tailored to giving them social information in a friendly way that helps them understand and learn healthy social behaviours. Research shows that Social Stories can reduce stress, anxiety, aggression and challenging behaviours, and improve classroom harmony and social and emotional wellbeing (Gray, 2000; Wright et al, 2016). It has not yet been tested in a large study. In order to make sure that this research was possible, we successfully tested it in a small study (n=50) (Wright et al, 2016). A guide for parents and teachers (with their help) on how to write and use Social Stories was developed which we will use in this study. This study will be carried out in schools across Yorkshire and Humber. Each school will be randomised (e.g. like a coin toss) so that participants at that school will either read a Social Story or receive care as usual (CAU). This method was planned with advice from our PPI representatives our successful feasibility study. There will be 278 participant groups. Each group will include a child with ASD (aged 4-11), the child’s teacher/teaching assistant (TA), another teacher/TA at the child’s school, and the child’s parent. We will train teachers and parents in groups to write a tailored Social Story for each child. This was successful in the feasibility trial. Children in the Social Stories group will have their Social Story read to them regularly by a teacher/TA. If the intervention is shown to be helpful, at the end of the study, participants in the CAU group will be offered free Social Stories training. Usual support will be available to all families (e.g. parenting support). We will measure social and emotional wellbeing and ASD symptoms to see if Social Stories work better than CAU. We will also use other questionnaires (e.g. for mood and anxiety) and a goal-based measure. Some of the participants will be observed in their class to monitor goal behaviour. We will measure the costs of Social Stories and CAU to see if there are any differences between the groups (e.g. health service use, school attendance or need for extra support). All questionnaires will be completed at baseline, and at 6 weeks and 6 months. At the end of the study teachers will complete a questionnaire exploring intervention use with the child and with other children. During the feasibility trial the parents and teachers of children with ASD were regularly included in management meetings. We will continue working closely with a similar group throughout all stages of the trial. We will publish our research findings in open access journals. We will also present findings at national conferences and at parent groups, education forums and with policy makers.

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