title: Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components.
abstract: BACKGROUND
  A Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour.
  
  
  OBJECTIVE
  The objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools.
  
  
  METHODS
  This is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage.
  
  
  METHODS
  Qualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools.
  
  
  METHODS
  Fifty children (aged 5-15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited.
  
  
  METHODS
  The intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual.
  
  
  METHODS
  Outcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index.
  
  
  RESULTS
  The review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided.
  
  
  CONCLUSIONS
  Blinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates.
  
  
  CONCLUSIONS
  The study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population.
  
  
  BACKGROUND
  This study is registered as PROSPERO CRD42011001440.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN96286707.
  
  
  BACKGROUND
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.
authors.affiliation: Lime Trees Child and Adolescent Mental Health Service Research Team, York, UK.
authors.forename: Barry
authors.initials: B
authors.lastname: Wright
authors.affiliation: Lime Trees Child and Adolescent Mental Health Service Research Team, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Marshall
authors.affiliation: York Clinical Trials Unit, Department of Health Sciences, York, UK.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: York Clinical Trials Unit, Department of Health Sciences, York, UK.
authors.forename: Hannah
authors.initials: H
authors.lastname: Ainsworth
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Shehzad
authors.initials: S
authors.lastname: Ali
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Allgar
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Danielle
authors.initials: D
authors.lastname: Collingridge Moore
authors.affiliation: York Clinical Trials Unit, Department of Health Sciences, York, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Cook
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Dempster
authors.affiliation: Lime Trees Child and Adolescent Mental Health Service Research Team, York, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Hackney
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Dean
authors.initials: D
authors.lastname: McMillan
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Dominic
authors.initials: D
authors.lastname: Trepél
authors.affiliation: Lime Trees Child and Adolescent Mental Health Service Research Team, York, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Williams
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D001007:Anxiety / Q000517:prevention & control; D000067877:Autism Spectrum Disorder / Q000523:psychology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D005240:Feasibility Studies; D006801:Humans; D007398:Interpersonal Relations; D008603:Mental Health; D033262:Narration; D010290:Parents / Q000523:psychology; D016032:Randomized Controlled Trials as Topic / Q000191:economics