Autism Spectrum DisorderNCT05712512
Experimental Techniques for Early Identification of Autism
An observational study of Autism Spectrum Disorder and Infant Development, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
This project deals with essential challenges in the context of Autism Spectrum Disorder, benefiting from a longitudinal design in infancy and a cutting-edge electroencephalogram/eye-tracking integrated approach. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Autism Spectrum Disorder, Infant Development
- What is being tested?
- Neurodevelopmental assessment and Electrophysiological and eyetracking recordings
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2021to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Longitudinal sample of infant siblings of children with autism
Who may be able to join
- Infants aged between 6 and 36 months
- Toddlers at elevated likelihood of developing autism because siblings of children with autism
Who cannot join
- gestational age <36 weeks
- Griffiths general quotient < 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
About this study
Official title: Early Identification of Autism Spectrum Disorder: Towards an Integrated Biomarker Approach
This project deals with essential challenges in the context of Autism Spectrum Disorder, benefiting from a longitudinal design in infancy and a cutting-edge electroencephalogram/eye-tracking integrated approach. The investigators will focus on multisensory audiovisual integration to identify early markers of autism in infants at-risk for autism. The investigators will characterize early derailments from the typical developmental trajectories to identify critical "time windows" and better describe the heterogeneity of autism.
Read the detailed description
Autism Spectrum Disorder is a heterogeneous condition characterized by atypical social communication and repetitive patterns of behavior, with recent Italian prevalence estimates of one in 77. The heterogeneity of autism is expressed in individual variation not only in the severity of core symptoms but also in cognitive, language, and behavioral skills, which show different developmental trajectories. Moreover, there is a strong interest in identifying reliable behavioral and brain-based predictors, which may constitute useful tools for early detection of at-risk cases. In particular, autistic individuals perform poorly during conditions that require integration across multiple sensory modalities such as audiovisual sensory integration, and process differently social and non-social stimuli compared to neurotypical counterparts.
However, the study of potential interaction between sensory and social processing in the first years of life is still scarce. No study examined early social and sensory markers in infant siblings of autistic children using integrated experimental techniques.
The study includes siblings of autistic children and neurotypical toddlers recruited at 18 months and a follow-up evaluation is collected at 24 months. At both time-points, all children are assessed with an experimental protocol, including behavioral and neurophysiological measures.
The integrated electroencephalogram -eyetracking task focuses on sensory processing in social (face saying "wow" in infant-directed speech) and non-social (spinning top toy) conditions. Presented videos are presented both in synchronous and asynchronous modalities (1000 ms delay audio presentation). Electroencephalographic signal is recorded by High-Density 128-channel system and pupil dilations are recorded using a Tobii ProSpectrum 300 Hertz system. In addition, complete information about clinical measures is collected for all children at 18 and 24 months.
- Conditions
- Autism Spectrum Disorder, Infant Development
- Being tested
- Neurodevelopmental assessment, Electrophysiological and eyetracking recordings
- Keywords
- siblings, biomarker, autism, infants
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental assessmentBehavioural
individual behavioral and socio-communicative assessment from 6 to 36 months
Electrophysiological and eyetracking recordingsOther
Investigation of neural and behavioral biomarkers of autism from 6 to 24 months
| Study group | Role | What they receive |
|---|---|---|
| Infant siblings of children with autism spectrum disorder | Not described Receives: Behavioral: Neurodevelopmental assessment; Other: Electrophysiological and eyetracking recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive outcome of standardized tests
standardized scores (i.e., Intelligence quotient scores) of Griffiths scales will be measured and will be correlated with electroencephalographic and eyetracking parameters
Measured: age 36 months
Socio-communicative outcome of standardized tests
standardized scores (Calibrated severity scores) of Autism Diagnostic Observation Schedule - 2 edition (Social Affect, Restricted/Repetitive behaviors) will be measured and will be correlated with electroencephalographic and eyetracking parameters
Measured: age 36 months
Sensory outcome of standardized tests
standardized scores (i.e., z-scores) of sensory profile-2 (sensory seeking, avoiding, sensitivity, registration) will be measured and will be correlated with electroencephalographic and eyetracking parameters
Measured: age 36 months
Change of electroencephalografic theta power and looking behavior during development
Electroencephalographic theta power, looking behavior (time of fixation in different areas of interest, pupillometry parameters) to synchronous/asynchronous audio-visual stimuli will be measured longitudinally.
Measured: at 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start19 Jul 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712512
- Sponsor's protocol ID
- 845
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Autism Spectrum Disorder: Towards an Integrated Biomarker Approach
- ClinicalTrials.gov ID
- NCT05712512
- Acronym / sponsor ID
- 845
- Conditions
- Autism Spectrum Disorder, Infant Development
- Keywords
- siblings, biomarker, autism, infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project deals with essential challenges in the context of Autism Spectrum Disorder, benefiting from a longitudinal design in infancy and a cutting-edge electroencephalogram/eye-tracking integrated approach. The investigators will focus on multisensory audiovisual integration to identify early markers of autism in infants at-risk for autism. The investigators will characterize early derailments from the typical developmental trajectories to identify critical "time windows" and better describe the heterogeneity of autism.
Detailed description
Autism Spectrum Disorder is a heterogeneous condition characterized by atypical social communication and repetitive patterns of behavior, with recent Italian prevalence estimates of one in 77. The heterogeneity of autism is expressed in individual variation not only in the severity of core symptoms but also in cognitive, language, and behavioral skills, which show different developmental trajectories. Moreover, there is a strong interest in identifying reliable behavioral and brain-based predictors, which may constitute useful tools for early detection of at-risk cases. In particular, autistic individuals perform poorly during conditions that require integration across multiple sensory modalities such as audiovisual sensory integration, and process differently social and non-social stimuli compared to neurotypical counterparts.
However, the study of potential interaction between sensory and social processing in the first years of life is still scarce. No study examined early social and sensory markers in infant siblings of autistic children using integrated experimental techniques.
The study includes siblings of autistic children and neurotypical toddlers recruited at 18 months and a follow-up evaluation is collected at 24 months. At both time-points, all children are assessed with an experimental protocol, including behavioral and neurophysiological measures.
The integrated electroencephalogram -eyetracking task focuses on sensory processing in social (face saying "wow" in infant-directed speech) and non-social (spinning top toy) conditions. Presented videos are presented both in synchronous and asynchronous modalities (1000 ms delay audio presentation). Electroencephalographic signal is recorded by High-Density 128-channel system and pupil dilations are recorded using a Tobii ProSpectrum 300 Hertz system. In addition, complete information about clinical measures is collected for all children at 18 and 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant siblings of children with autism spectrum disorder | – | Behavioral: Neurodevelopmental assessment, Other: Electrophysiological and eyetracking recordings |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Longitudinal sample of infant siblings of children with autism
Key inclusion criteria (2 listed)
- Infants aged between 6 and 36 months
- Toddlers at elevated likelihood of developing autism because siblings of children with autism
Key exclusion criteria (4 listed)
- gestational age <36 weeks
- Griffiths general quotient < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental assessmentindividual behavioral and socio-communicative assessment from 6 to 36 months | Behavioural | Infant siblings of children with autism spectrum disorder |
| Electrophysiological and eyetracking recordingsInvestigation of neural and behavioral biomarkers of autism from 6 to 24 months | Other | Infant siblings of children with autism spectrum disorder |
Primary outcome
Cognitive outcome of standardized tests
Time frame: age 36 months
standardized scores (i.e., Intelligence quotient scores) of Griffiths scales will be measured and will be correlated with electroencephalographic and eyetracking parameters
Socio-communicative outcome of standardized tests
Time frame: age 36 months
standardized scores (Calibrated severity scores) of Autism Diagnostic Observation Schedule - 2 edition (Social Affect, Restricted/Repetitive behaviors) will be measured and will be correlated with electroencephalographic and eyetracking parameters
Sensory outcome of standardized tests
Time frame: age 36 months
standardized scores (i.e., z-scores) of sensory profile-2 (sensory seeking, avoiding, sensitivity, registration) will be measured and will be correlated with electroencephalographic and eyetracking parameters
Change of electroencephalografic theta power and looking behavior during development
Time frame: at 6, 12, 18 and 24 months
Electroencephalographic theta power, looking behavior (time of fixation in different areas of interest, pupillometry parameters) to synchronous/asynchronous audio-visual stimuli will be measured longitudinally.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Infant Development, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive outcome of standardized tests (time frame: age 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.