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New treatment option for Autism Spectrum Disorder
Official title Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT05673096
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 6
You may be able to join if
- 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...
- 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...
- The ASD diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conference
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aabenraa, Denmark
- Aalborg, Denmark
- Aarhus, Denmark
- Hellerup, Denmark
- Odense, Denmark
- Roskilde, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aabenraa, Denmark; Aalborg, Denmark; Aarhus, Denmark; Hellerup, Denmark; Odense, Denmark; Roskilde, Denmark. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.