Abstract
<jats:sec id="abs1-1"><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-2"><jats:title>Objectives</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-3"><jats:title>Design</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-4"><jats:title>Setting</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-5"><jats:title>Participants</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-6"><jats:title>Interventions</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-7"><jats:title>Main outcome measures</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-8"><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-9"><jats:title>Limitations</jats:title><jats:p>Blinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates.</jats:p></jats:sec><jats:sec id="abs1-10"><jats:title>Conclusions</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="abs1-11"><jats:title>Study registration</jats:title><jats:p>This study is registered as PROSPERO CRD42011001440.</jats:p></jats:sec><jats:sec id="abs1-12"><jats:title>Trial registration</jats:title><jats:p>Current Controlled Trials ISRCTN96286707.</jats:p></jats:sec><jats:sec id="abs1-13"><jats:title>Funding</jats:title><jats:p>This project was funded by the NIHR Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment</jats:italic>; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.</jats:p></jats:sec>
Original language | English |
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Pages (from-to) | 1-258 |
Number of pages | 0 |
Journal | Health Technology Assessment |
Volume | 20 |
Issue number | 6 |
DOIs | |
Publication status | E-pub ahead of print - Jan 2016 |