Abstract
BACKGROUND: Autistic children can experience mental health, social and emotional difficulties. Carol Gray's Social Stories™ are a highly personalised intervention that provide social information in a short individually tailored story. METHODS: A multi-site pragmatic cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of Social Stories™ alongside care as usual in autistic children aged 4-11 years. The primary outcome was the Social Responsiveness Scale-2 completed by teachers 6 months post-randomisation, analysed on an intention-to-treat basis. TRIAL REGISTRATION: ISRCTN11634810. RESULTS: Eighty-seven schools, including 249 children, were randomised (intervention 44 schools with 129 children, and usual care 43 schools with 120 children). After 6 months, a reduction of 1.61 points was found on the Social Responsiveness Scale-2 in the intervention group (95% CI -4.18 to 0.96, p = .220) and for those who attended at least six sessions a reduction of 3.37 points (CACE 95% CI -6.65 to -0.10, p = .043). Children in the intervention group met their individual socio-emotional goal more frequently than children receiving usual care alone and this was statistically significant. No statistically significant differences were found in other secondary outcomes including anxiety, depression, general health or parental stress. CONCLUSIONS: Social Stories™ represent a low-cost, low-burden intervention. Benefits are seen in individual socio-emotional goals but without clinically evident impact on social responsiveness, anxiety, depression, parental stress or general health.