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Clinical Trials/ISRCTN96286707
ISRCTN96286707
Completed
未知

Autism Spectrum Social Stories In Schools Trial: a feasibility randomised controlled trial

HS North Yorkshire and York (UK)0 sites50 target enrollmentSeptember 9, 2011

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
HS North Yorkshire and York (UK)
Enrollment
50
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 9, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
HS North Yorkshire and York (UK)

Eligibility Criteria

Inclusion Criteria

  • In the feasibility RCT stage of the study,
  • 1\. Children will only be recruited between the ages of 4\-15 years
  • 2\. Have a definite diagnosis of an ASD and have behavioural problems in school (as reported by parents and teachers)
  • 3\. We will prescreen children for challenging behaviour, using clinical interviews and measures informed by the systematic review, which may include the Strengths and Difficulties Questionnaire and the Developmental Behaviour Checklist
  • We have deliberately kept the age range broad in order to explore the acceptability of this intervention across age ranges and different settings (e.g. primary and secondary schools) and inform a fully powered trial.

Exclusion Criteria

  • This is a pragmatic trial which recognises the frequency and complexity of co\-morbidities in children with autism spectrum disorders (ASD). We will therefore not exclude on the basis of comorbidity since the intervention would eventually be offered to this group if adopted more widely in the NHS. This will ensure that the research remains relevant to everyday clinical practice. This means for example that we will include children and young people with a learning disability, epilepsy, attentional problems, neurological disorders or syndromes (e.g. CHARGE syndrome, Fragile X syndrome etc).
  • We will exclude:
  • 1\. Any child from the study if they have used a Social Story within the last six months
  • 2\. Children and young people if they are likely to be moving school during the trial period, or if they develop behaviour or illness that warrants admission to a psychiatric unit (e.g. psychosis, serious self harm).
  • These exclusion criteria were informed by discussions with parents who had previously used Social Stories in a focus group prior to submitting the full application. Children will only be randomised into the trial if they exhibit challenging behaviours using the validated cut offs from the Strengths and Difficulties Questionnaire or the Developmental Behaviour Checklist.

Outcomes

Primary Outcomes

Not specified

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