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Experimental Techniques for Early Identification of Autism

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05712512
Enrollment
100
Registered
2023-02-03
Start date
2021-07-19
Completion date
2024-03-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Infant Development

Keywords

siblings, biomarker, autism, infants

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.

Interventions

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

OTHERElectrophysiological and eyetracking recordings

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

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive outcome of standardized testsage 36 monthsstandardized scores (i.e., Intelligence quotient scores) of Griffiths scales will be measured and will be correlated with electroencephalographic and eyetracking parameters
Socio-communicative outcome of standardized testsage 36 monthsstandardized 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
Sensory outcome of standardized testsage 36 monthsstandardized 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
Change of electroencephalografic theta power and looking behavior during developmentat 6, 12, 18 and 24 monthsElectroencephalographic theta power, looking behavior (time of fixation in different areas of interest, pupillometry parameters) to synchronous/asynchronous audio-visual stimuli will be measured longitudinally.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026