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

Not Applicable

Completed

• Conditions: Early Intervention; Autism Spectrum Disorder
• Interventions: Behavioral: Behavioral intervention based on Applied Behavior Analysis principles

• Registration Number: NCT05614206
• Lead Sponsor: IRCCS Eugenio Medea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-26
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-14
• Primary Completion: 2023-09-26
• Study Completion: 2024-09-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toddlers at elevated likelihood of developing autism with autistic signs, with early intervention	Behavioral intervention based on Applied Behavior Analysis principles	Toddlers at elevated likelihood of developing autism with clinical autistic signs who receive an early intervention from 18 to 24 months

Primary Outcome Measures

Name	Time	Method
Change of looking behavior (time of fixations to Area of Interests) and pupillometry parameters (pupil diameter)	once at 24 months of age	Time of fixations (milliseconds) in different Areas of Interests (i.e., month and eyes) and pupil diameters (millimeters) will be recorded and analysed in the 4 groups at T0 (18 months) and T1 (24 months)
Change of electroencephalographic theta power (theta frequency band)	once at 24 months of age	Electroencephalographic theta power to synchronous/asynchronous social and nonsocial stimuli will be measured as an index of social and sensory processing in the 4 groups at T0 (18 months) and T1 (24 months). High-density 128 channel is recorded continuously throughout the session

Secondary Outcome Measures

Name	Time	Method
Change of standardized scores of clinical measures	Twice: at 18 and at 24 months of age	Standardized scores (i.e., z-scores, T-scores) of clinical tests (Griffiths Scales, Autism Diagnostic Observation Schedule-Second Edition, McArthur Questionnaire Sensory Profile) will be measured and will be correlated with electroencephalographic (theta power) and eyetracking (looking behavior and pupillometry parameters) data

Trial Locations

Locations (1)

Associazione La Nostra Famiglia - IRCCS Eugenio Medea; 🇮🇹 Bosisio Parini, Lecco, Italy