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Multicenter Validation Study on Autism Screening Using a Machine-assisted System

NCT07006948 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-09-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)

The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.

DIAGNOSTIC_TEST

Griffiths Developmental Scales, Chinese edition(GDS-C)

The toddlers diagnosed with ASD, GDD, LD, and typically developing will receive the GDS-C evaluation to confirm the diagnosis.

Sponsors & Collaborators

  • Harbin Institute of Technology, Shenzhen

    collaborator UNKNOWN

  • Kunshan City Maternal and Child Health

    collaborator OTHER

  • Hefei First People's Hospital

    collaborator UNKNOWN

  • Ningbo Women & Children's Hospital

    collaborator OTHER

  • Xiamen Children's Hospital

    collaborator OTHER

  • Chengdu Women's and Children's Central Hospital

    collaborator OTHER

  • Liuzhou Maternity and Child Healthcare Hospital

    collaborator OTHER

  • Xian Children's Hospital

    collaborator OTHER_GOV

  • Dehong People's Hospital

    collaborator UNKNOWN

  • The Sixth Affiliated Hospital of Harbin Medical University

    collaborator UNKNOWN

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Xiu Xu · Children's Hospital of Fudan University

Eligibility

Min Age
18 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2028-06-15
Completion
2029-06-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07006948 on ClinicalTrials.gov