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Autism Spectrum Social Stories in Schools Trial (ASSSIST): Study

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Autism Spectrum Social Stories in Schools Trial (ASSSIST): Study Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2014-005952 on 9 July 2014. Downloaded from Autism Spectrum Social Stories In Schools Trial (ASSSIST): study protocol for a feasibility randomised controlled trial analysing clinical and cost- effectiveness of Social Stories in mainstream schools Barry Wright,1 David Marshall,1 Danielle Collingridge Moore,2 Hannah Ainsworth,3 Lisa Hackney,1 Joy Adamson,3 Shehzad Ali,2 Victoria Allgar,2 Liz Cook,3 Lisa Dyson,3 Elizabeth Littlewood,2 Rebecca Hargate,1 Anne McLaren,1 Dean McMillan,2 Dominic Trépel,2 Jo Whitehead,1 Chris Williams1 To cite: Wright B, ABSTRACT Strengths and limitations of this study Marshall D, Collingridge Introduction: Current evidence suggests that Social Moore D, et al. Autism Stories can be effective in tackling problem behaviours ▪ Spectrum Social Stories In Schools in the study will be cluster randomised exhibited by children with autism spectrum disorder. Schools Trial (ASSSIST): to avoid treatment contamination. ’ study protocol for a feasibility Exploring the meaning of behaviour from a child s ▪ The study will address an under-researched area randomised controlled trial perspective allows stories to provide social information and will produce important research evidence to analysing clinical and cost- that is tailored to their needs. Case reports in children inform the education of young people in the UK effectiveness of Social with autism have suggested that these stories can lead to National Health Service (NHS). Stories in mainstream a number of benefits including improvements in social ▪ An economic analysis will be used to make the BMJ Open schools. 2014;4: interactions and choice making in educational settings. trial comparative to large numbers of other e005952. doi:10.1136/ http://bmjopen.bmj.com/ Methods and analysis: The feasibility of clinical and studies. bmjopen-2014-005952 cost-effectiveness of a Social Stories toolkit will be ▪ The sample of participants will be obtained from assessed using a randomised control framework. only one NHS Trust resulting in potential for ▸ Prepublication history for Participants (n=50) will be randomised to either the Social minorities to be under-represented. this paper is available online. Stories intervention or a comparator group where they will ▪ Blinding of participants will not be feasible due To view these files please be read standard stories for an equivalent amount of time. to the nature of the intervention. visit the journal online Statistics will be calculated for recruitment rates, follow-up (http://dx.doi.org/10.1136/ rates and attrition. Economic analysis will determine bmjopen-2014-005952). appropriate measures of generic health and resource use social rules by observing others as their typic- on September 28, 2021 by guest. Protected copyright. categories for cost-effectiveness analysis. Qualitative Received 20 June 2014 ally developing peers might do. Consequently, Accepted 26 June 2014 analysis will ascertain information on perceptions about their behaviour can be interpreted as disrup- the feasibility and acceptability of the intervention. 1 Ethics and dissemination: National Health Service tive. Parents and teachers report more behav- Ethics Approval (NHS; ref 11/YH/0340) for the trial iour problems in children with ASD than in 2 protocol has been obtained along with NHS Research and typically developing children. Many children Development permission from Leeds and York Partnership with ASD therefore need specifictrainingto NHS Foundation Trust. All adverse events will be closely learn these skills. monitored, documented and reported to the study Data Social Stories are short stories which Monitoring Ethics Committee. At least one article in a peer describe a social situation or skill to help reviewed journal will be published and research findings children with ASD. They are commonly used presented at relevant conferences. to enable children to understand socially Trial registration number: ISRCTN96286707. expected behaviours. Gray3, the original designer, identified 10 criteria which guide For numbered affiliations see story development. These criteria ensure that end of article. the story structure and content is descriptive, INTRODUCTION meaningful and safe for its audience. Correspondence to Children with autistic spectrum disorder Social Stories can be effective in tackling David Marshall; (ASD) are less able to intuitively understand problem behaviours when they set out to [email protected] how they are expected to behave or to learn explicitly teach social skills.4 Until recently, Wright B, et al. BMJ Open 2014;4:e005952. doi:10.1136/bmjopen-2014-005952 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005952 on 9 July 2014. Downloaded from research exploring efficacy and outcome has been con- METHODS fined to single case studies. These case reports in chil- Study design dren with ASD have suggested improvements in social We aim to examine the feasibility of a cluster RCT to be interactions,56choice making in an educational conducted to compare the clinical and cost-effectiveness setting,6 voice volume in class7 and mealtime skills.8 of Social Stories with an attention control. Qualitative Success has also been reported in addressing disruptive interviews will be conducted within the feasibility design behaviours, including reducing tantrums910and beha- to explore the acceptability of the intervention and its viours associated with frustration.11 delivery. The study will be conducted between Non-comparative research has examined Social Story November 2011 and October 2014. use in special education12 and mainstream education set- tings,13 as well as their application within the home.14 This Inclusion criteria research suggests that it is possible to train tier one profes- Child participants will be recruited between the ages of sionals, for example teachers, in the use of Social Stories 5 and 15 years, will be required to have a previous diag- and for these stories to benefitchildrenwithASD.15 nosis of ASD (including autism, Asperger syndrome and There is little consensus on the effects of Social atypical autism) using International Classification of Stories, highlighted in two systematic reviews of their Diseases 10th revision, research diagnostic criteria,17 sup- effectiveness.416The reviews identified largely single ported by Autism Diagnostic Interview-Revised case designs, displayed a paucity of good quality, com- (ADI-R),18 and/or autism diagnostic observation sched- parative evidence on Social Stories and showed the ule (ADOS).19 Participants will be required to have necessity of further research regarding whether positive behavioural or social problems in school (as reported by outcome (as seen in case series) could be replicated parents and teachers). We have deliberately kept the age within a randomised controlled trial (RCT). range broad in order to explore the acceptability of this Evidence suggests that Social Stories delivered in a intervention across age ranges and different settings (eg, general education setting produced significantly larger primary and secondary schools) to inform a fully effect sizes on behaviour than those implemented at powered trial. home or in self-contained settings, such as separate This is a pragmatic trial which recognises the fre- schools or self-contained classrooms4; therefore, this quency and complexity of comorbidities in children with study specifically focuses on the feasibility of assessing ASD. We will therefore not exclude participants on the Social Stories delivered within a mainstream schooling basis of comorbidity since the intervention would even- system. tually be offered to this group if adopted more widely in Although Social Stories have much potential to the National Health Service (NHS). This will ensure that http://bmjopen.bmj.com/ improve behaviour, the comparative evidence base is the research remains relevant to everyday clinical limited and attributed levels of effect are based mostly practice. on single case research. A well-designed RCT is required to address this important gap in our knowledge, and a Exclusion criteria feasibility RCT is required to plan the appropriate Children will not be included in the study if they have experimental design. In particular, the intervention has used a Social Story within the past 6 months. We will largely been used in special education and its use in exclude children if they are likely to be moving school mainstream education, where it has large potential, during the trial period, or if they develop an illness or on September 28, 2021 by guest. Protected copyright. needs exploring. behaviour that warrants admission to a psychiatric unit (eg, psychosis and serious self-harm). These exclusion criteria were informed by discussions with parents who AIMS AND OBJECTIVES had previously used Social Stories in a focus group prior At present, there is insufficient information to indicate to submitting the funding application. how to conduct a full-scale RCT. Therefore, we plan to design and conduct a feasibility study which will inform Recruitment procedure the design of a full RCT of clinical and cost-effectiveness. The research team will give presentations about the Our feasibility study has the following aims: research to local autism support groups,20 and provide 1. To conduct a feasibility RCT comparing a manualised presentations and leaflets through clinicians to parents Social Stories intervention with an attention control of children with ASD attending
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