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Recruiting
NCT05673096
Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
Conditions: Autism Spectrum Disorder
Sex: All
Ages: 2 Years – 6 Years
Phase: NA
Enrollment: 280
Sponsor: University of Southern Denmark
Location: Denmark
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 Criteria
Inclusion Criteria: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, DF84.8An Autism Diagnostic Observation Schedule, 2nd Edition Calibrated Severity Score (ADOS-2 CSS) ≥ 4The ASD diagnosis must be verified by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Autism Spectrum Disorder ChecklistThe ASD diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conferenceParents must have sufficient Danish (or English) language skills to communicate with the therapistSigned informed consent by parents or holders of legal guardianshipExclusion Criteria:Children having a sibling already included in the trialHearing and visual impairment in child or parentParent not available for regular sessions with the therapist, evaluated at the consent meeting
Source: ClinicalTrials.gov (NCT05673096). StuddyBuddy aggregates publicly available trial information.