Clinical trial NCT05673096: Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Region Capital Denmark
name: Region Zealand
name: Region of Southern Denmark
name: Central Denmark Region
name: Regionshospital Nordjylland
First posted: 2023-01-06
Enrollment: 280
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Autism Symptoms
timeFrame: End of intervention (14 months)
Secondary outcomes:
measure: Child adaptive functioning
timeFrame: End of intervention (14 months)
measure: Social interaction of the child
timeFrame: At 6 month and end of intervention (14 months)
measure: Quality of Life (child)
timeFrame: End of intervention (14 months)
measure: Quality of life (parents)
timeFrame: End of intervention (14 months)
Other outcomes:
measure: Parent-child synchrony and initiative in communication
timeFrame: At 6 month and end of intervention (14 months)
measure: Parent implementation of strategy
timeFrame: End of intervention (14 months)
measure: Behavioural and emotional problems
timeFrame: End of intervention (14 months)
measure: Family life functioning
timeFrame: End of intervention (14 months)
measure: Social impairment
timeFrame: End of intervention (14 months)
measure: Parental reflective functioning
timeFrame: End of intervention (12 months)
measure: Child attachment
timeFrame: End of intervention (14 months)
measure: Adverse events
timeFrame: End of intervention (14 months)
measure: Serious Adverse Events
timeFrame: End of intervention (14 months)
measure: Cost-effectiveness
timeFrame: End of intervention (14 months)
measure: Parents' perceptions of the intervention
timeFrame: End of intervention (14 months)
measure: Receptive language
timeFrame: End of intervention (14 months)
measure: Language
timeFrame: End of intervention (14 months)
Locations:
city: Aabenraa
country: Denmark
facility: Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark
city: Aalborg
country: Denmark
facility: Child and Adolescent Mental Health Center, Aalborg, North Denmark Region
city: Aarhus
country: Denmark
facility: Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital
city: Hellerup
country: Denmark
facility: Child and Adolescent Mental Health Center, Capital Region of Denmark
city: Odense
country: Denmark
facility: Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark
city: Roskilde
country: Denmark
facility: Department of Child and Adolescent Psychiatry, Copenhagen University Hospital
Study officials:
affiliation: Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark + Clinical Institute, University of Southern Denmark
name: Niels Bilenberg, Professor
role: STUDY_CHAIR
References: