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

Last updated: December 5, 2024
Sponsor: University of Southern Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Williams Syndrome

Asperger's Disorder

Treatment

MAU

PACT

Clinical Study ID

NCT05673096
DAN-PACT
  • Ages 2-6
  • All Genders

Study 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

Inclusion Criteria:

  • Children aged 2 through 6 years (both inclusive)

  • A diagnosis of ASD meeting the criteria for International Classification ofDiseases; 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 ofMental Disorders, Fifth Edition (DSM-5), Autism Spectrum Disorder Checklist

  • The ASD diagnosis must be the primary developmental disorder (comorbid conditionsallowed) and conferred at a clinical conference

  • Parents must have sufficient Danish (or English) language skills to communicate withthe therapist

  • Signed informed consent by parents or holders of legal guardianship

Exclusion

Exclusion Criteria:

  • 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 theconsent meeting

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: MAU
Phase:
Study Start date:
March 13, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting approximately 2% of children and young people worldwide. ASD is considered a lifelong disorder and interventions significantly reducing the core autistic symptoms have been sparse. Paediatric Autism Communication Therapy (PACT) is among the first naturalistic developmental behavioural interventions to show promising results for reduction in 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 ASD.

This trial is an investigator-initiated, independently funded, pragmatic, national, parallel group, superiority, randomised clinical trial comparing PACT combined with management as usual to management as usual alone.

Connect with a study center

  • Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark

    Aabenraa, 6200
    Denmark

    Active - Recruiting

  • Child and Adolescent Mental Health Center, Aalborg, North Denmark Region

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Child and Adolescent Mental Health Center, Capital Region of Denmark

    Hellerup, 2900
    Denmark

    Active - Recruiting

  • Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark

    Odense, 5000
    Denmark

    Active - Recruiting

  • Department of Child and Adolescent Psychiatry, Copenhagen University Hospital

    Roskilde, 4000
    Denmark

    Active - Recruiting

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