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Recruiting
NCT05614206
Biomarkers Trajectories of Early Intervention in Siblings of Children With Autism Spectrum Disorder
Conditions: Autism Spectrum Disorder, Early Intervention
Sex: All
Ages: 18 Months – 24 Months
Healthy volunteers: 1
Phase: NA
Enrollment: 80
Sponsor: IRCCS Eugenio Medea
Location: Italy
Summary
This project deals with essential challenges in the context of Autism Spectrum Disorder benefiting from a prospective design in childhood, early intervention and a cutting-edge experimental techniques.
The present study tests the potential effect of early intervention on neural and behavioral responses in toddlers at elevated likelihood of developing autism (siblings of children with autism) who show clinical autistic signs.
Four comparison groups were included in the study: (1) toddlers at elevated likelihood of developing autism with clinical autistic signs who receive early intervention from 18 to 24 months (2) toddlers at elevated likelihood of developing autism with clinical autistic signs who do not receive early intervention (3) toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring, and (4) typically developing toddlers who only received assessment and monitoring.This study focuses on social and nonsocial sensory integration skills (measured by electroencephalographic and eyetracking recordings) to identify reliable biomarkers for early detection and intervention of autism during a critical period of development.The characterization of biomarkers will guide the detection of the most vulnerable children that will benefit from early intervention, with the long-term aim of reducing the impact of autism on the National Health System.
Eligibility Criteria
Inclusion Criteria:Toddlers aged between 18 and 24 monthsToddlers at elevated likelihood of developing autism, because siblings of children with a diagnosis of autism (for group 1, 2, and 3)Exclusion Criteria:Gestational age <36 weeks and/or birthweight < 2000 gramsGriffiths general quotient at 18 months < 70presence of major complications in pregnancy and/or delivery likely to affect brain developmentpresence of neurological deficits, dysmorphic markers, or other medical conditions.
Source: ClinicalTrials.gov (NCT05614206). StuddyBuddy aggregates publicly available trial information.