Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PACT, MAU.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 2 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Behavioral PACT
Paediatric Autism Communication Therapy - Behavioral MAU
Management as usual
Primary outcome measures
- Autism Symptoms [Time frame: End of intervention (14 months)]
Secondary outcome measures (4)
- Child adaptive functioning [Time frame: End of intervention (14 months)]
- Social interaction of the child [Time frame: At 6 month and end of intervention (14 months)]
- Quality of Life (child) [Time frame: End of intervention (14 months)]
- Quality of life (parents) [Time frame: End of intervention (14 months)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 6 centers
- Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark — Aabenraa
- Child and Adolescent Mental Health Center, Aalborg, North Denmark Region — Aalborg
- Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital — Aarhus
- Child and Adolescent Mental Health Center, Capital Region of Denmark — Hellerup
- Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark — Odense
- Department of Child and Adolescent Psychiatry, Copenhagen University Hospital — Roskilde
Publications
- Ziegler SMT, Jeppesen P, Christiansen J, Conrad CE, Davidsen KA, Engkjaer-Trautwein G, Engstrom J, Fagerlund B, Gotzsche MV, Hastrup LH, Jakobsen JC, Kirk AM, Lauritsen MB, Pagsberg AK, Pedersen MA, Kilburn TR, Thomsen PH, Varenne M, Bilenberg N. Paediatric Autism Communication Therapy (PACT) versus management as usual in autistic children: a protocol for a Danish pragmatic, national, randomised c PMID 40883837
Identifiers
NCT: NCT05673096 · DAN-PACT