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Communication Therapy Study for Young Children With Autism

Tests a communication therapy alongside usual care in children aged 2 to 6 with autism.

Plain-language title generated from the registry record
Registry title: Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder

Key facts

Where
Aabenraa, Aalborg, Aarhus, Hellerup, Odense, and Roskilde, DenmarkSee the 6 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 6 years old?

Source: NCT05673096, who can take part

Where in Denmark

  • Child and Adolescent Mental Health Center, Aabenraa, Region of Southern DenmarkAabenraa, DenmarkTaking people
  • Child and Adolescent Mental Health Center, Aalborg, North Denmark RegionAalborg, DenmarkTaking people
  • Child and Adolescent Psychiatric Dept., Skejby, Aarhus University HospitalAarhus, DenmarkTaking people
  • Child and Adolescent Mental Health Center, Capital Region of DenmarkHellerup, DenmarkTaking people
  • Child and Adolescent Mental Health Center, Odense, Region of Southern DenmarkOdense, DenmarkTaking people
  • Department of Child and Adolescent Psychiatry, Copenhagen University HospitalRoskilde, DenmarkTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Southern Denmark
Trial code
NCT05673096
Record updated
11 December 2024
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Hearing and visual impairment in child or parent; Children having a sibling already included in the trial; Parent not available for regular sessions with the therapist, evaluated at the consent meeting.

ClinicalTrials.gov NCT05673096