Skip to main content
OpenTrials
Completed

NCT Number: NCT05712512

Experimental Techniques for Early Identification of Autism

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Infant Development Mental Disorders Neurodevelopmental Disorders

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

About this study

Autism Spectrum Disorder is a heterogeneous condition characterized by atypical social communication and repetitive patterns of behavior, with recent Italian prevalence estimates of one in 77. The heterogeneity of autism is expressed in individual variation not only in the severity of core symptoms but also in cognitive, language, and behavioral skills, which show different developmental trajectories. Moreover, there is a strong interest in identifying reliable behavioral and brain-based predictors, which may constitute useful tools for early detection of at-risk cases. In particular, autistic individuals perform poorly during conditions that require integration across multiple sensory modalities such as audiovisual sensory integration, and process differently social and non-social stimuli compared to neurotypical counterparts.

However, the study of potential interaction between sensory and social processing in the first years of life is still scarce. No study examined early social and sensory markers in infant siblings of autistic children using integrated experimental techniques.

The study includes siblings of autistic children and neurotypical toddlers recruited at 18 months and a follow-up evaluation is collected at 24 months. At both time-points, all children are assessed with an experimental protocol, including behavioral and neurophysiological measures.

The integrated electroencephalogram -eyetracking task focuses on sensory processing in social (face saying "wow" in infant-directed speech) and non-social (spinning top toy) conditions. Presented videos are presented both in synchronous and asynchronous modalities (1000 ms delay audio presentation). Electroencephalographic signal is recorded by High-Density 128-channel system and pupil dilations are recorded using a Tobii ProSpectrum 300 Hertz system. In addition, complete information about clinical measures is collected for all children at 18 and 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Neurodevelopmental assessment

Behavioral

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

Electrophysiological and eyetracking recordings

Other

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

Primary outcomes

  1. Cognitive outcome of standardized tests

    Time frame: age 36 months

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

  2. Socio-communicative outcome of standardized tests

    Time frame: age 36 months

    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

  3. Sensory outcome of standardized tests

    Time frame: age 36 months

    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

  4. Change of electroencephalografic theta power and looking behavior during development

    Time frame: at 6, 12, 18 and 24 months

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

Early Identification of Autism Spectrum Disorder: Towards an Integrated Biomarker Approach

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 3, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.