NCT07377227

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

November 17, 2025

Last Update Submit

February 4, 2026

Conditions

Eye-trackingAutism Spectrum DisorderSocial CognitionDiagnosis

Keywords

Eye-trackingAutism Spectrum DisorderSocial CognitionDiagnosis

Outcome Measures

Primary Outcomes (2)

  • differences in visual exploration patterns between both groups

    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

    Classification performance of machine learning algorithms in distinguishing ASD from TD

    2 years

Secondary Outcomes (3)

  • Correlations between eye-tracking measures and cognitive scores

    2 years

  • Developmental trajectory analysis in TD children

    2 years

  • Identification of cognitive subgroups within ASD group

    2 years

Study Arms (2)

Autism Spectrum Disorder

EXPERIMENTAL

Autism Spectrum Disorder

Other: eye-trackingOther: cognitive assessments

typically developing peers

ACTIVE COMPARATOR

typically developing (TD) peers

Other: eye-trackingOther: cognitive assessments

Interventions

eye-trackingOTHER

eye-tracking

Autism Spectrum Disordertypically developing peers
cognitive assessmentsOTHER

cognitive assessments

Autism Spectrum Disordertypically developing peers

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amiens hospital

Amiens, 80000, France

Location

MeSH Terms

Conditions

Autism Spectrum DisorderDisease

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Federica Cilia, MD

CONTACT

33+3 22 66 75 40Cilia.Federica-ext@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 29, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)