Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): study protocol for a randomised controlled trial analysing clinical and cost-effectiveness of Social Stories™ in primary schools

Abstract

Background: Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC) can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs). Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely. Methods: A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This study will recruit 278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England. Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants' social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have been obtained from the University of York's Research Governance Committee, Research Ethics Committee and the Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and disseminated to participating families, educational staff, local authority representatives, community groups and Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence dependent on findings.

Cost–utility analysis of Social Stories™ for children with autism spectrum disorder in mainstream primary schools: results from a randomised controlled trial

“…The protocol for the ASSSIST-2 trial has been published elsewhere. 12 In brief, children diagnosed with autism spectrum disorder and aged between 4 and 11 years were recruited from mainstream primary schools in Yorkshire and Humber from November 2018 to May 2021. Parents/guardians and schools were approached to discuss eligibility and provide consent.…”

“…Stories were then developed around specific goals that were agreed by teachers, interventionists and parents/guardians to address the child's need for social information. To deliver the intervention, interventionists read the Social Story with the child at least six times over 4 weeks, during school hours, with some level of flexibility to make changes in delivery 12 depending on factors such as accessibility for the child and logistical issues at school.…”

“…Data on service use were gathered through two tailored questionnaires 12 developed by the research team, based on our previously successful school-based trial, the Investigating Social Competence and Isolation in Children with Autism taking part in LEGO-based Therapy Clubs in School Environments (I-SOCIALISE) trial. 5 The questionnaire completed by parents/guardians collects information on healthcare services utilisation, including both hospital-based services and those outside a hospital setting, such as community health services, services provided by allied health professionals, mental health services and social services.…”

Challenges and Perspectives of Evidence-Based Interventions Integration into Schooling of Children with

“…Есть надежда, что скоро появятся масштабные исследования социальных историй. Например, Б. Райт с коллегами [51] сообщают о планирующемся рандомизированном и контролируемом исследовании с участием 278 детей в возрасте 4-11 лет, однако остается открытым вопрос, как специалист будет принимать решение о вмешательстве в случае отсутствия положительного эффекта на индивидуальном уровне.…”