ISRCTN25378536
Completed
N/A
Paediatric Autism Communication Trial – Generalised (PACT-G)
Central Manchester & Manchester Children's University Hospitals NHS Trust & University of Manchester0 sites249 target enrollmentMarch 10, 2016
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Central Manchester & Manchester Children's University Hospitals NHS Trust & University of Manchester
- Enrollment
- 249
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30241574 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35305746/ (added 21/03/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35605069/ (added 25/04/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 18/10/2017:
- •1\. Child over 2 years 0 months and under 11 years 0 months
- •2\. Child has confirmed diagnosis of autism spectrum disorder
- •3\. Child meets criteria for core autism on the Autism Diagnostic Observation Schedule (ADOS\-2\) and the Social Communication Questionnaire
- •4\. Children who are aged 5 years and over are between P3 and P8 for the English curriculum
- •5\. Parent has spoken English which is adequate to participate in this communication based intervention and speaks English to their child at least some of the time
- •Previous inclusion criteria:
- •1\. Child between 2 and 11 years (in primary school) with a diagnosis of autism
- •2\. Family will have spoken English at home which is adequate to allow them potentially to participate in this communication based intervention
- •Pre\-school cohort:
Exclusion Criteria
- •Current exclusion criteria as of 18/10/2017:
- •1\. Having a sibling with ASD already in the trial
- •2\. Participation in PACT pilot phase
- •3\. Child has \<\= 12 months nonverbal age equivalent
- •4\. Long\-term severe hearing or visual impairment in child or parent
- •5\. Epilepsy that is uncontrolled by medication
- •6\. Severe learning disability in the parent or current clinically severe psychiatric illness in parent
- •7\. Current safeguarding concerns or other family situation that would affect child / family participation in the trial
- •8\. No agreement to participate from child’s education setting
- •Previous exclusion criteria:
Outcomes
Primary Outcomes
Not specified
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