Autism Spectrum DisorderNCT05614206
Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder
A study testing Behavioral intervention based on Applied Behavior Analysis principles in people with Autism Spectrum Disorder and Early Intervention, 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 prospective design in childhood, early intervention and a cutting-edge experimental techniques. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Early Intervention
- What is being tested?
- Behavioral intervention based on Applied Behavior Analysis principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2022to 26 Sep 2024
- Phase
- Interventional
- 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 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Bosisio Parini, Lecco, 23842
About this study
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
- Being tested
- Behavioral intervention based on Applied Behavior Analysis principles
- Keywords
- siblings, autism, biomarkers, early intervention
- 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.
Behavioral intervention based on Applied Behavior Analysis principlesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Toddlers at elevated likelihood of developing autism with autistic signs, with early intervention | Experimental | Toddlers at elevated likelihood of developing autism with clinical autistic signs who receive an early intervention from 18 to 24 months Receives: Behavioral: Behavioral intervention based on Applied Behavior Analysis principles |
| Toddlers at elevated likelihood of developing autism with autistic signs, without early intervention | No intervention | 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 autistic signs who received monitoring | No intervention | Toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring |
| Typically developing toddlers who received monitoring | No intervention | Typically developing toddlers who only received assessment and monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: once at 24 months of age
Secondary outcomes (1)
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
Measured: Twice: at 18 and at 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start26 Sep 2022
- Primary completion26 Sep 2023
- Study completion26 Sep 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT05614206
- Sponsor's protocol ID
- 897
- Status last verified
- Mar 2025
- First submitted
- 3 Nov 2022
- 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
- Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05614206
- Acronym / sponsor ID
- 897
- Conditions
- Autism Spectrum Disorder, Early Intervention
- Keywords
- siblings, autism, biomarkers, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 14 Nov 2022 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Toddlers at elevated likelihood of developing autism with autistic signs, with early intervention | Experimental | Behavioral: Behavioral intervention based on Applied Behavior Analysis principlesToddlers at elevated likelihood of developing autism with clinical autistic signs who receive an early intervention from 18 to 24 months |
| Toddlers at elevated likelihood of developing autism with autistic signs, without early intervention | No intervention | –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 autistic signs who received monitoring | No intervention | –Toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring |
| Typically developing toddlers who received monitoring | No intervention | –Typically developing toddlers who only received assessment and monitoring |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Behavioral intervention based on Applied Behavior Analysis principlesIntervention 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. | Behavioural | Toddlers at elevated likelihood of developing autism with autistic signs, with early intervention |
Primary outcome
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
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
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)
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)
1 secondary outcome
Change of standardized scores of clinical measures
Time frame: Twice: at 18 and at 24 months of age
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?
A study testing Behavioral intervention based on Applied Behavior Analysis principles in people with Autism Spectrum Disorder and Early Intervention, 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?
Change of electroencephalographic theta power (theta frequency band) (time frame: once at 18 months of age). 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.