Communication therapy for children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Paediatric Autism Communication Therapy (PACT) is designed to reduce symptoms of autism in children aged 2-6 years who have recently been diagnosed with Autism Spectrum Disorder (ASD). This trial will compare the effects of PACT combined with standard management to standard management alone. It aims to evaluate both the beneficial and harmful effects of this intervention in a pragmatic, randomized clinical trial format. The study is independently funded and conducted across multiple centers in Denmark.

Why it matters

Who can join: the full rules

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, DF84.8
* 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 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 the consent meeting

Where it's running

• Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark
  Aabenraa, Denmark Recruiting
• Child and Adolescent Mental Health Center, Aalborg, North Denmark Region
  Aalborg, Denmark Recruiting
• Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Child and Adolescent Mental Health Center, Capital Region of Denmark
  Hellerup, Denmark Recruiting
• Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark
  Odense, Denmark Recruiting
• Department of Child and Adolescent Psychiatry, Copenhagen University Hospital
  Roskilde, Denmark Recruiting

Study contacts

• Study coordinator: Niels Bilenberg, Professor
• Email: Niels.Bilenberg@rsyd.dk
• Phone: +4599448683

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.