Multicenter Validation Study on Autism Screening Using a Machine-assisted System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-30
SponsorChildren's Hospital of Fudan University
About this trial
The goal of this observational study is to assess the effectiveness of a machine-assisted system for early screening of autism. The main questions it aims to answer are:
* Does the machine-assisted system including 5 main behavioral paradigms identify toddlers with autism from those with other neurodevelopmental disorders and typical development? * Are there any differences in the early symptoms of autism among toddlers over the whole mainland China? Participants will receive some developmental and social communicational evaluations for clinical diagnoses. They will also receive the behavior evaluations of the machine-assisted system. The above evaluations will be performed just once.
Eligibility criteria
Qualifiers
Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
Ages 1.5-2.5 years;
Parents/caregivers understand the content of the study and agree to participate in.
Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g;
Disqualifiers
Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
Children with brain injuries, specific chronic or congenital diseases.
The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
Healthy, typically developing toddlers aged 1.5-2.5 years ;
Trial design
Treatments tested in this trial
- Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)
- Griffiths Developmental Scales, Chinese edition(GDS-C)
Treatment groups
1,000 Participants
are divided into 4 treatment groupsSponsors and collaborators
Children's Hospital of Fudan University
Lead sponsor
Harbin Institute of Technology, Shenzhen
Collaborator
Kunshan City Maternal and Child Health
Collaborator
Hefei First People's Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Xiamen Children's Hospital
Collaborator
Chengdu Women's and Children's Central Hospital
Collaborator
Liuzhou Maternity and Child Healthcare Hospital
Collaborator
Xian Children's Hospital
Collaborator
Dehong People's Hospital
Collaborator
The Sixth Affiliated Hospital of Harbin Medical University
Collaborator
Source ClinicalTrials.gov