- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377227
Social COgnition Screening (ECoS-A)
Evaluation of Social Cognition: A New Screening Approach for Autism
Social cognition refers to the mental processes involved in social interactions, including social perception, motivation, communication, emotion recognition, and theory of mind. Face perception plays a key role in children's social development, but children with Autism Spectrum Disorder (ASD) tend to look less at social stimuli, especially faces, than typically developing (TD) peers. Eye-tracking studies highlight these visual exploration differences, linked to difficulties in joint attention, emotion recognition, and theory of mind, as well as in executive and memory functions. Standard diagnostic tests often require active participation and sufficient language, which makes assessment challenging for children with ASD and additional cognitive or language impairments.
This research project investigates how visual activity supports social cognition depending on cognitive and language levels, hypothesizing that eye-tracking can provide useful indicators for ASD screening and diagnosis.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Federica Cilia, MD
- Phone Number: 33+3 22 66 75 40
- Email: Cilia.Federica-ext@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80000
- Amiens Hospital
-
Contact:
- Federica Cilia, MD
- Phone Number: 33+3 22 66 75 40
- Email: Cilia.Federica-ext@chu-amiens.fr
-
Sub-Investigator:
- Sébastien Garny De La Rivière, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASD Group:
- Boys or girls diagnosed with Autism Spectrum Disorder (based on clinical tools and observations)
- Aged between 4 and 10 years old
- Affiliation with a social security scheme
- Informed consent of those with parental authority
- DT Group:
- Boys or girls
- Aged between 4 and 10
- Attending school in the Hauts-de-France region
- Affiliation with a social security scheme
- Consent of those with parental authority
Exclusion Criteria:
- For ASD: Uncorrected visual or auditory impairments.
- For DT: Intellectual disability, neurological or genetic disorders, autistic traits reported by teachers. The discrepancy between actual age and abilities calculated on the basis of standardised test scores
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autism Spectrum Disorder
|
eye-tracking
cognitive assessments
|
|
Active Comparator: typically developing peers
typically developing (TD) peers
|
eye-tracking
cognitive assessments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
differences in visual exploration patterns between both groups
Time Frame: 2 years
|
Differences in visual exploration patterns between both groups Visual exploration patterns are determined with TOM Test Battery, PPVT-5, Raven's 2 and FEE tests
|
2 years
|
|
Classification performance of machine learning algorithms in distinguishing ASD from TD
Time Frame: 2 years
|
Classification performance of machine learning algorithms in distinguishing ASD from TD
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlations between eye-tracking measures and cognitive scores
Time Frame: 2 years
|
Eye-tracking patterns are determined with TOM Test Battery, PPVT-5, Raven's 2 and FEE tests
|
2 years
|
|
Developmental trajectory analysis in TD children
Time Frame: 2 years
|
2 years
|
|
|
Identification of cognitive subgroups within ASD group
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2025_843_0181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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