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

IRCCS Eugenio Medea

Status: Completed

Conditions: Autism Spectrum Disorder; Early Intervention

Treatments: Behavioral: Behavioral intervention based on Applied Behavior Analysis principles

Study type: Interventional

Funder types: Other

Identifiers

NCT05614206

897

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 24 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Toddlers at elevated likelihood of developing autism with autistic signs, with early intervention

Experimental group

Description:

Toddlers at elevated likelihood of developing autism with clinical autistic signs who receive an early intervention from 18 to 24 months

Treatment:

Behavioral: Behavioral intervention based on Applied Behavior Analysis principles

Toddlers at elevated likelihood of developing autism with autistic signs, without early intervention

No Intervention group

Description:

Toddlers at elevated likelihood of developing autism with clinical autistic signs who do not receive an early intervention

Toddlers at elevated likelihood of developing autism without autistic signs who received monitoring

No Intervention group

Description:

Toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring

Typically developing toddlers who received monitoring

No Intervention group

Description:

Typically developing toddlers who only received assessment and monitoring