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
This trial accepts healthy volunteersQualifiers
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 population
The diagnostic accuracy study will be performed in children with ASD, GDD, LD, and healthy, typically developing children aged between 1.5 to 2.5 years old.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)
Diagnostic testThe toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.
Griffiths Developmental Scales, Chinese edition(GDS-C)
Diagnostic testThe toddlers diagnosed with ASD, GDD, LD, and typically developing will receive the GDS-C evaluation to confirm the diagnosis.
Treatment groups
1,000 Participants
are divided into 4 treatment groupsGroup A: ASD group2 interventions
Group B: GDD group1 intervention
Group C: LD group1 intervention
Group D: TD group1 intervention
Trial outcomes
Primary outcomes
1
Total Score of 5 main social behaviors
The 5 main social behaviors include Response to name, Response to instructions, Joint attention, request by pointing, and free play. Scores of the 5 scenes range from 0 to 4, and the total score ranges from 0 to 16. Higher score indicates better social skills. Subjects' behaviors will be scored both by investigators and the machine-assisted system.
Time frame
The assessment will be performed during 1.5 to 2.5 years old.2
Clinical diagnoses
The clinical diagnoses of autism spectrum disorder (ASD), global developmental delay (GDD), and language disorder (LD) will be made according to the standard of DSM-5. The diagnosis of ASD will be confirmed by The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F) and Autism Diagnostic Observation Schedule, the 2nd edition (ADOS-2). The diagnoses of GDD and LD will be confirmed by Griffiths Development Scales-Chinese edition (GDS-C). Subjects in TD group will also receive assessments of M-CHAT-R/F, (negative) and GDS-C (DQs\>75).
Time frame
The diagnoses will be made during 1.5 to 2.5 years old.3
Scores of Autism Diagnostic Observation Schedule-2nd edition(ADOS-2)
The scores of social affect and restricted repetitive behaviors and the comparison score of ADOS-2 will be used for confirming the clinical diagnosis of autism spectrum disorder(ASD). The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.
Time frame
The assessment will be performed during 1.5 to 2.5 years old.4
development quotient development quotient Development quotients (DQs) of Griffiths Developmental Scales-Chinese edition(GDS-C)
DQs of Griffiths Development Scales-Chinese edition(GDS-C) will be used for confirming the diagnoses of global developmental delay(GDD) and language disorder(LD), also be used to evaluate the development level of typically developing toddlers. The average scores of DQ in different domains are 100, and the standard deviations are 15. The DQ lower than 70(including 70) means lower than normal.
Time frame
The assessment will be performed during 1.5 to 2.5 years old.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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