ORCID

Abstract

ObjectivesTo assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial.DesignA single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control.Setting37 primary schools in York, UK.Participants50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27).Outcome measuresAcceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial.ResultsAn assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups.ConclusionsResults suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools.Trial registration numberISRCTN96286707; Results.

DOI

10.1136/bmjopen-2016-011748

Publication Date

2016-08-01

Publication Title

BMJ Open

Volume

6

Issue

8

First Page

e011748

Last Page

e011748

ISSN

2044-6055

Organisational Unit

Peninsula Medical School

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