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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Associazione La Nostra Famiglia - IRCCS Eugenio Medea Coordinator of this site? Confirm its status | Bosisio Parini | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.