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

NCT05614206 | Completed

• 1 other identifier: 897
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Early Intervention

Keywords

siblings; autism; biomarkers; early intervention

Outcome Measures

Primary Outcomes (4)

• Change of electroencephalographic theta power (theta frequency band)

  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

  once at 18 months of age

• Change of electroencephalographic theta power (theta frequency band)

  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

  once at 24 months of age

• Change of looking behavior (time of fixations to Area of Interests) and pupillometry parameters (pupil diameter)

  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)

  once at 18 months of age

• Change of looking behavior (time of fixations to Area of Interests) and pupillometry parameters (pupil diameter)

  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)

  once at 24 months of age

Secondary Outcomes (1)

• Change of standardized scores of clinical measures

  Twice: at 18 and at 24 months of age

Study Arms (4)

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

EXPERIMENTAL

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

Behavioral: Behavioral intervention based on Applied Behavior Analysis principles

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

NO INTERVENTION

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

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

Typically developing toddlers who only received assessment and monitoring

Interventions

Behavioral intervention based on Applied Behavior Analysis principles BEHAVIORAL

Intervention sessions are conducted by licensed therapists with a training in applied behavior analysis or behavior analysts. One-to-one interventions for 3 h/week are carried out over a period of 5 months. The intervention focused on two target symptoms, imitation and joint attention, as two of the pivotal skills in early development. Behavior analytic techniques are used, including discrete trial, shaping for positive reinforcement, systematic prompting and fading procedures, and reinforcement procedures, according to the published manual. Imitation sessions start with imitation recognition and imitation of familiar actions (gestural and object imitation) and end with the imitation of novel actions. Joint attention evolvs from initiating requests (starting with gaze shift with the child looking away from an interesting object to the adult and back) to coordination of gaze shift, vocalization and gestures through reaching, and pointing and showing behaviors.

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

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 14, 2022
• Study Start: September 26, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)