Experimental Techniques for Early Identification of Autism

NCT05712512 | Completed

• 1 other identifier: 845
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This project deals with essential challenges in the context of Autism Spectrum Disorder, benefiting from a longitudinal design in infancy and a cutting-edge electroencephalogram/eye-tracking integrated approach. The investigators will focus on multisensory audiovisual integration to identify early markers of autism in infants at-risk for autism. The investigators will characterize early derailments from the typical developmental trajectories to identify critical "time windows" and better describe the heterogeneity of autism.

Conditions

Autism Spectrum Disorder; Infant Development

Keywords

siblings; biomarker; autism; infants

Outcome Measures

Primary Outcomes (4)

• Cognitive outcome of standardized tests

  standardized scores (i.e., Intelligence quotient scores) of Griffiths scales will be measured and will be correlated with electroencephalographic and eyetracking parameters

  age 36 months

• Socio-communicative outcome of standardized tests

  standardized scores (Calibrated severity scores) of Autism Diagnostic Observation Schedule - 2 edition (Social Affect, Restricted/Repetitive behaviors) will be measured and will be correlated with electroencephalographic and eyetracking parameters

  age 36 months

• Sensory outcome of standardized tests

  standardized scores (i.e., z-scores) of sensory profile-2 (sensory seeking, avoiding, sensitivity, registration) will be measured and will be correlated with electroencephalographic and eyetracking parameters

  age 36 months

• Change of electroencephalografic theta power and looking behavior during development

  Electroencephalographic theta power, looking behavior (time of fixation in different areas of interest, pupillometry parameters) to synchronous/asynchronous audio-visual stimuli will be measured longitudinally.

  at 6, 12, 18 and 24 months

Study Arms (1)

Infant siblings of children with autism spectrum disorder

Behavioral: Neurodevelopmental assessment; Other: Electrophysiological and eyetracking recordings

Interventions

Neurodevelopmental assessment BEHAVIORAL

individual behavioral and socio-communicative assessment from 6 to 36 months

Infant siblings of children with autism spectrum disorder

Electrophysiological and eyetracking recordings OTHER

Investigation of neural and behavioral biomarkers of autism from 6 to 24 months

Infant siblings of children with autism spectrum disorder

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Longitudinal sample of infant siblings of children with autism

You may qualify if:

• Infants aged between 6 and 36 months
• Toddlers at elevated likelihood of developing autism because siblings of children with autism

You may not qualify if:

• gestational age \<36 weeks
• Griffiths general quotient \< 70
• presence of major complications in pregnancy and/or delivery likely to affect brain development
• presence of neurological deficits, dysmorphic markers, or other medical conditions

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: July 19, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)