NCT01647295

Brief Summary

The primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism. The second objective of this work will be to achieve in a population of children with autism a longitudinal evaluation of these markers during development and therapeutics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

February 25, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

December 4, 2025

Status Verified

August 1, 2021

Enrollment Period

6.3 years

First QC Date

July 19, 2012

Last Update Submit

November 26, 2025

Conditions

Keywords

visual explorationpupil sizesocial interactionsfaceshuman motion

Outcome Measures

Primary Outcomes (1)

  • Total time spent on pictures

    Total time tracked during exploration of faces and human motion, compared to objects

    two years

Secondary Outcomes (1)

  • Interest zones

    two years

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Autistic children from the University Hospital of Tours Healthy children from the normal population

You may qualify if:

  • For autistic children, diagnosis of autism spectrum disorders according to DSM IV-TR and ADI / ADOS criteria ; normal or corrected vision; no nervous system disease
  • For healthy children, normal schooling and normal or corrected vision
  • For all, parental consents

You may not qualify if:

  • psychotropic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Bretonneau

Tours, 37044, France

Location

Related Publications (1)

  • Aguillon-Hernandez N, Mofid Y, Latinus M, Roche L, Bufo MR, Lemaire M, Malvy J, Martineau J, Wardak C, Bonnet-Brilhault F. The pupil: a window on social automatic processing in autism spectrum disorder children. J Child Psychol Psychiatry. 2020 Jul;61(7):768-778. doi: 10.1111/jcpp.13170. Epub 2019 Dec 11.

MeSH Terms

Conditions

Autism Spectrum DisorderDiGeorge Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornHypoparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 23, 2012

Study Start

February 25, 2013

Primary Completion

June 1, 2019

Study Completion

June 18, 2019

Last Updated

December 4, 2025

Record last verified: 2021-08

Locations