An interventional study of Behavioral intervention based on Applied Behavior Analysis principles in Autism Spectrum Disorder and Early Intervention, sponsored by IRCCS Eugenio Medea. Completed at 1 site in Italy. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Prevention
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 80 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →IRCCS Eugenio Medea is the lead sponsor of 104 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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 clinical autistic signs who do not receive an early intervention
Toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring
Typically developing toddlers who only received assessment and monitoring
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.
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: once at 24 months of age
Change of standardized scores of clinical measures
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
Time frame: Twice: at 18 and at 24 months of age
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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IRCCS Eugenio Medea