NCT05673096Recruiting
Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 22 Dec 2022
- Start date
- 13 Mar 2023
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- University of Southern Denmark
- Diseases
- Autism
- NCT number
- NCT05673096
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 13 Mar 2023 to the primary completion date, 1 Mar 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hearing and visual impairment in child or parent
Other
- Children having a sibling already included in the trial
- Parent not available for regular sessions with the therapist, evaluated at the consent meeting
Who the study is looking for
- 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
Age in the registry: 2 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark Coordinator of this site? Confirm its status | Aabenraa | Denmark | Recruiting |
| Child and Adolescent Mental Health Center, Aalborg, North Denmark Region Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Child and Adolescent Mental Health Center, Capital Region of Denmark Coordinator of this site? Confirm its status | Hellerup | Denmark | Recruiting |
| Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Department of Child and Adolescent Psychiatry, Copenhagen University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.