About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PACT
- MAU
Treatment groups
Sponsors and collaborators
University of Southern Denmark
Lead sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Region Capital Denmark
Collaborator
Region Zealand
Collaborator
Region of Southern Denmark
Collaborator
Central Denmark Region
Collaborator
Regionshospital Nordjylland
Collaborator