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Clinical Trials/ISRCTN25378536
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)

Registry
who.int
Start Date
March 10, 2016
End Date
July 30, 2019
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Central Manchester & Manchester Children's University Hospitals NHS Trust & University of Manchester

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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