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NCT05614206Completed

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

Source: ClinicalTrials.gov · Last updated 14 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
80 (actual)
First submitted
3 Nov 2022
Start date
26 Sept 2022
Primary completion date
26 Sept 2023
Lead sponsor
IRCCS Eugenio Medea
Diseases
Autism
NCT number
NCT05614206

What you commit to

  • Study type: Interventional
  • Participants enrolled: 80
  • From 26 Sept 2022 to the primary completion date, 26 Sept 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Age

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

Other

  • Griffiths general quotient at 18 months \< 70
  • presence of major complications in pregnancy and/or delivery likely to affect brain development

Who the study is looking for

  • Toddlers aged between 18 and 24 months
  • Toddlers at elevated likelihood of developing autism, because siblings of children with a diagnosis of autism (for group 1, 2, and 3)

Age in the registry: 18 months to 24 months · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Coordinator of this site? Confirm its status
Bosisio PariniItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.