Experimental Techniques for Early Identification of Autism

NCT ID: NCT05712512

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2024-03-31

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.

Detailed Description

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.

Conditions

Autism Spectrum Disorder; Infant Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infant siblings of children with autism spectrum disorder

Neurodevelopmental assessment

Intervention Type: BEHAVIORAL

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

Electrophysiological and eyetracking recordings

Intervention Type: OTHER

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

Interventions

Neurodevelopmental assessment

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

Intervention Type: BEHAVIORAL

Electrophysiological and eyetracking recordings

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, LC, Italy

Countries

Italy

Other Identifiers

845

Identifier Type: -

Identifier Source: org_study_id