Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
Paediatric Autism Communication Therapy (PACT) Combined With Management as Usual Compared to Management as Usual Alone in Children With Autism Spectrum Disorder - a Pragmatic, National, Randomised Clinical Trial
University of Southern Denmark
280 participants
Mar 13, 2023
INTERVENTIONAL
Conditions
Summary
Paediatric Autism Communication Therapy (PACT) is a naturalistic developmental behavioural interventions to reduce autism symptoms. The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of autism spectrum disorder.
Eligibility
Inclusion Criteria7
- Children aged 2 through 6 years (both inclusive)
- A diagnosis of ASD meeting the criteria for International Classification of Diseases; Tenth Edition (ICD-10): Diagnose codes: DF84.0, DF84.1, DF84.5, DF84.8
- An Autism Diagnostic Observation Schedule, 2nd Edition Calibrated Severity Score (ADOS-2 CSS) ≥ 4
- The ASD diagnosis must be verified by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Autism Spectrum Disorder Checklist
- The ASD diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conference
- Parents must have sufficient Danish (or English) language skills to communicate with the therapist
- Signed informed consent by parents or holders of legal guardianship
Exclusion Criteria3
- Children having a sibling already included in the trial
- Hearing and visual impairment in child or parent
- Parent not available for regular sessions with the therapist, evaluated at the consent meeting
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Interventions
Paediatric Autism Communication Therapy
Management as usual
Locations(6)
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NCT05673096