Autism or Autistic TraitsNCT06329245
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
An observational study of Autism or Autistic Traits and Healthy, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 0 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism or Autistic Traits, Healthy
- What is being tested?
- Do not take any interventions
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Jul 2029
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The longitude study will be performed in high-risk infants of ASD who have at least one older sibling with a clinical diagnosis of ASD. The low-risk group will also be recruited from healthy infants as control group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.
Who may be able to join
- Subjects were enrolled as high-risk if they had an older sibling with a clinical diagnosis of ASD confirmed on the Autism Diagnostic Observation Schedule, second edition (ADOS-2) or Autism Diagnostic Interview (ADI-R).
- Subjects were enrolled in the low-risk group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.
Who cannot join
- diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile X syndrome) reported to be associated with ASDs;
- a significant medical or neurological condition affecting growth, development or cognition (e.g., CNS infection, seizure disorder, congenital heart disease);
- sensory impairment such as vision or hearing loss;
- low birth weight (<2000 grams) or prematurity (<37 weeks gestation);
- possible perinatal brain injury from exposure to in-utero exogenous compounds reported to likely affect the brain adversely in at least some individuals (e.g., alcohol, selected prescription medications);
- contraindication for MRI (e.g., metal implants);
- a family history of intellectual disability, psychosis, schizophrenia or bipolar disorder in a first-degree relative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai
Xiu Xu, PhD
About this study
The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state.
Read the detailed description
The longitude observational study will be performed to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). We will follow up the subjects at 3-, 6-, 9-, 12-, 18-, 24-, 30-, and 36-month-old. Clinical diagnosis will be made on 24-month-old or after, with the DSM-5 as the diagnostic criterion.
- Conditions
- Autism or Autistic Traits, Healthy
- Being tested
- Do not take any interventions
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do not take any interventionsOther
Do not take any interventions
| Study group | Role | What they receive |
|---|---|---|
| high-risk group | Subjects in the case group have one or more older siblings with ASD. Receives: Other: Do not take any interventions | |
| low-risk group | Subjects in the controlled group do not have older siblings with ASD. Receives: Other: Do not take any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical diagnosis
Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2.
Measured: At about 2.5 to 3 year-old.
neurodevelopmental outcome
The neurodevelopmental outcome will be measured by Griffiths Mental Developemental Scales. The developmental ages (DA) are referred from the norms and developmental quotients (DQs) are calculated by DA/CA (chronological age)*100. Higher DQ indicates better development. The normal range of the DQ is above 70.
Measured: At 6, 12, 18, 24, and 36-month-old.
Prosocial behaviors
The prosocial behaviors will be measured by different behavior paradigms including helper-and-hinder, crying baby, and Theory of Mind.
Measured: At 6, 12, 18, 24, and 36-month-old.
nuclear magnetic resonance imaging(MRI)
Cranial MRI data will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Measured: At 6, 12, 18, 24, and 36-month-old.
Event related potentials (ERPs)
ERPs will be tested using eego™ mylab of ANT Neuro company. Mu suppression、N1/N2、P3/LPP will be compared between children with ASD and typical development.
Measured: At 6, 12, 18, 24, and 36-month-old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism or Autistic TraitsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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 (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- ShanghaiTech University
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329245
- Sponsor's protocol ID
- brainpro2022
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
- ClinicalTrials.gov ID
- NCT06329245
- Acronym / sponsor ID
- brainpro2022
- Conditions
- Autism or Autistic Traits, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- ShanghaiTech University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 25 Mar 2024 (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.
The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state.
Detailed description
The longitude observational study will be performed to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). We will follow up the subjects at 3-, 6-, 9-, 12-, 18-, 24-, 30-, and 36-month-old. Clinical diagnosis will be made on 24-month-old or after, with the DSM-5 as the diagnostic criterion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-risk group | – | Other: Do not take any interventionsSubjects in the case group have one or more older siblings with ASD. |
| low-risk group | – | Other: Do not take any interventionsSubjects in the controlled group do not have older siblings with ASD. |
Who may qualify
- Ages
- 0 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The longitude study will be performed in high-risk infants of ASD who have at least one older sibling with a clinical diagnosis of ASD. The low-risk group will also be recruited from healthy infants as control group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.
Key inclusion criteria (2 listed)
- Subjects were enrolled as high-risk if they had an older sibling with a clinical diagnosis of ASD confirmed on the Autism Diagnostic Observation Schedule, second edition (ADOS-2) or Autism Diagnostic Interview (ADI-R).
- Subjects were enrolled in the low-risk group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.
Key exclusion criteria (7 listed)
- diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile X syndrome) reported to be associated with ASDs;
- a significant medical or neurological condition affecting growth, development or cognition (e.g., CNS infection, seizure disorder, congenital heart disease);
- sensory impairment such as vision or hearing loss;
- low birth weight (<2000 grams) or prematurity (<37 weeks gestation);
- possible perinatal brain injury from exposure to in-utero exogenous compounds reported to likely affect the brain adversely in at least some individuals (e.g., alcohol, selected prescription medications);
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 |
|---|---|---|
| Do not take any interventionsDo not take any interventions | Other | high-risk group, low-risk group |
Primary outcome
clinical diagnosis
Time frame: At about 2.5 to 3 year-old.
Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2.
neurodevelopmental outcome
Time frame: At 6, 12, 18, 24, and 36-month-old.
The neurodevelopmental outcome will be measured by Griffiths Mental Developemental Scales. The developmental ages (DA) are referred from the norms and developmental quotients (DQs) are calculated by DA/CA (chronological age)*100. Higher DQ indicates better development. The normal range of the DQ is above 70.
Prosocial behaviors
Time frame: At 6, 12, 18, 24, and 36-month-old.
The prosocial behaviors will be measured by different behavior paradigms including helper-and-hinder, crying baby, and Theory of Mind.
nuclear magnetic resonance imaging(MRI)
Time frame: At 6, 12, 18, 24, and 36-month-old.
Cranial MRI data will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Event related potentials (ERPs)
Time frame: At 6, 12, 18, 24, and 36-month-old.
ERPs will be tested using eego™ mylab of ANT Neuro company. Mu suppression、N1/N2、P3/LPP will be compared between children with ASD and typical development.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- 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.
Xiu Xu, doctor principal investigator
Children's Hospital of Fudan University
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 or Autistic Traits and Healthy, run by Children's Hospital of Fudan University at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingrui Zhou, doctor (13701989113, zbr1800@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical diagnosis (time frame: At about 2.5 to 3 year-old.). The study lists 5 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 16 Mar 2026.