Clinical trial NCT05614206: Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder
Official title: Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Early Intervention
Keywords: siblings
autism
biomarkers
early intervention
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change of electroencephalographic theta power (theta frequency band)
timeFrame: once at 18 months of age
measure: Change of electroencephalographic theta power (theta frequency band)
timeFrame: once at 24 months of age
measure: Change of looking behavior (time of fixations to Area of Interests) and pupillometry parameters (pupil diameter)
timeFrame: once at 18 months of age
measure: Change of looking behavior (time of fixations to Area of Interests) and pupillometry parameters (pupil diameter)
timeFrame: once at 24 months of age
Secondary outcomes:
measure: Change of standardized scores of clinical measures
timeFrame: Twice: at 18 and at 24 months of age
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Associazione La Nostra Famiglia - IRCCS Eugenio Medea
state: Lecco
Study officials:
References: