Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorUniversity of Southern Denmark

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

280 Participants
are divided into 2 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