RECRUITINGINTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form by parents or holders of legal guardianship
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BEHAVIORAL
PACT
Paediatric Autism Communication Therapy
BEHAVIORAL
MAU
Management as usual
Locations (6)
Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark
Aabenraa, Denmark
Child and Adolescent Mental Health Center, Aalborg, North Denmark Region
Aalborg, Denmark
Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital
Aarhus, Denmark
Child and Adolescent Mental Health Center, Capital Region of Denmark
Hellerup, Denmark
Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark
Odense, Denmark
Department of Child and Adolescent Psychiatry, Copenhagen University Hospital
Roskilde, Denmark