Communication therapy for children with autism

Paediatric Autism Communication Therapy (PACT) Combined With Management as Usual Compared to Management as Usual Alone in Children With Autism Spectrum Disorder - a Pragmatic, National, Randomised Clinical Trial

This study is testing whether a new communication therapy can help young children with autism feel better when combined with regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 2 Years to 6 Years
• Sex: All
• Sponsor: University of Southern Denmark (other)
• Locations: 6 sites (Aabenraa and 5 other locations)
• Trial ID: NCT05673096 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 6 years with a recent diagnosis of Autism Spectrum Disorder.

Not a fit: Children with significant hearing or visual impairments, or those whose parents cannot attend regular therapy sessions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce autism symptoms in young children, improving their communication skills and overall quality of life.

How similar studies have performed: Other studies have shown promising results with similar naturalistic developmental behavioral interventions for autism, indicating potential for success in this approach.

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, DF84.8
* 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 this trial is running

Aabenraa and 5 other locations

• 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

Conditions: Autism Spectrum Disorder