- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05614206
Biomarkers Trajectories of Early Intervention in Siblings of Children With Autism Spectrum Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lecco
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Bosisio Parini, Lecco, Italy, 23842
- Recruiting
- Associazione La Nostra Famiglia - IRCCS Eugenio Medea
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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. |
No Intervention: 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
|
|
No Intervention: 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
|
|
No Intervention: Typically developing toddlers who received monitoring
Typically developing toddlers who only received assessment and monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of electroencephalographic theta power (theta frequency band)
Time Frame: once at 18 months of age
|
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)
Time Frame: once at 24 months of age
|
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 Frame: once at 18 months of age
|
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 Frame: once at 24 months of age
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of standardized scores of clinical measures
Time Frame: Twice: at 18 and at 24 months of age
|
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
|
Twice: at 18 and at 24 months of age
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 897 (Other Grant/Funding Number: M.S.I. Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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