Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder

Last updated: March 11, 2025
Sponsor: IRCCS Eugenio Medea
Overall Status: Completed

Phase

N/A

Condition

Autism

Williams Syndrome

Asperger's Disorder

Treatment

Behavioral intervention based on Applied Behavior Analysis principles

Clinical Study ID

NCT05614206
897
  • Ages 18-24
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Toddlers aged between 18 and 24 months

  • Toddlers at elevated likelihood of developing autism, because siblings of childrenwith a diagnosis of autism (for group 1, 2, and 3)

Exclusion

Exclusion Criteria:

  • Gestational age <36 weeks and/or birthweight < 2000 grams

  • Griffiths general quotient at 18 months < 70

  • presence of major complications in pregnancy and/or delivery likely to affect braindevelopment

  • presence of neurological deficits, dysmorphic markers, or other medical conditions.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Behavioral intervention based on Applied Behavior Analysis principles
Phase:
Study Start date:
September 26, 2022
Estimated Completion Date:
September 26, 2024

Connect with a study center

  • Associazione La Nostra Famiglia - IRCCS Eugenio Medea

    Bosisio Parini, Lecco 23842
    Italy

    Site Not Available

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