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

NCT ID: NCT05614206

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2024-09-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Behavioral intervention based on Applied Behavior Analysis principles

Intervention Type: 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, without early intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Typically developing toddlers who received monitoring

Typically developing toddlers who only received assessment and monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral intervention based on Applied Behavior Analysis principles

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, Lecco, Italy

Countries

Italy

Other Identifiers

897

Identifier Type: -

Identifier Source: org_study_id