Autism Spectrum DisorderNCT06908174
Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development
An observational study of Autism Spectrum Disorder 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 brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Healthy
- What is being tested?
- ADOS-2
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to 1 Jul 2029
- How long will I take part?
- 2 Years
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The observation study will be performed in children with ASD and healthy, typically developing children.
Who may be able to join
- Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
- Ages 2-17 years;
- Parents/caregivers understand the content of the study and agree to participate in.
- Healthy children age between 2 to 17 years.
- Children without the family history of ASD or other neurodevelopmental/mental diseases.
- Parents/caregivers understand the content of the study and agree to participate in.
Who cannot join
- Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
- Children with brain injuries, specific chronic or congenital diseases.
- The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
- Children cannot receive the head MRI examination.
- Control group:
- Children with brain injuries, specific chronic or congenital diseases.
- The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
- Children cannot receive the head MRI examination.
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 brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). The main questions it aims to answer are as follows: 1. What are the differences of the functional brain network between autism and TD children? 2. What are the differences of the brain activity in response to special social stimulus between autism and TD children? Participants will receive developmental/intelligence assessments (Griffiths Mental Developmental Scales/Wechsler Preschool and Primary Scale of Intelligence-IV/Wechsler Intelligence Scale for Children-IV for children of different ages), social assessments(Autism Diagnostic Observation Schedule-2nd Edition/Social Communication Questionnaire), EEG/ERPs and fNIRs in resting and task states, and head MRI in natural sleeping state(without sedative).
Read the detailed description
The cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. The investigators will recruit children aged between 2 to 17 years and 11 months old. They need to receive the mentioned assessments and medical examinations for at least once.
- Conditions
- Autism Spectrum Disorder, Healthy
- Being tested
- ADOS-2
- Keywords
- autism
- 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.
ADOS-2Diagnostic test
The subjects in case group will receive the ADOS-2 assessment to confirm their diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Subjects in the case group are diagnosed with autism spectrum disorder according to DSM-V and clinical observation. Receives: Diagnostic Test: ADOS-2 | |
| Control group | Subjects in the control group are healthy children without serious chronic or congenital diseases. |
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. The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.
Measured: Baseline (during 2 to 17 years old).
Latencies in event related potentials(ERPs)
The investigators will explore the differences of N1/N2, P3/LPP and N400 in event related potentials (ERPs) between case and control groups (children with ASD and typical development) in responses to special prosocial stimulus, and also in false belief tasks. Event related potentials (ERPs) will be tested using eego™ mylab of ANT Neuro company.
Measured: Baseline (during 2 to 17 years old).
Amplitudes in ERPs
Amplitudes of N1/N2, P3/LPP and N400 will be compared between children with autism spectrum disorder and typical development.
Measured: Baseline (during 2 to 17 years old).
nuclear magnetic resonance imaging(MRI)
Cranial MRI data, including sMRI and fMRI, will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Measured: Baseline (during 2 to 17 years old).
Changes in the concentrations of Oxygenated Hemoglobin (HbO) and deoxygenated Hemoglobin (HbR) during interactions
The investigators will explore inter-group differences of children with ASD and typical development in the concentrations of HbO and HbR during social communication scenes between participants and investigators.
Measured: Baseline (during 2 to 17 years old).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start7 Apr 2025
- Primary completion1 Jul 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 Spectrum DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
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, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908174
- Sponsor's protocol ID
- brainpro2022-cross-sectional
- Status last verified
- May 2025
- First submitted
- 19 Feb 2025
- Last updated
- 29 May 2025
- Results posted
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development
- ClinicalTrials.gov ID
- NCT06908174
- Acronym / sponsor ID
- brainpro2022-cross-sectional
- Conditions
- Autism Spectrum Disorder, Healthy
- Keywords
- autism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- ShanghaiTech University
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 3 Apr 2025 (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 brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). The main questions it aims to answer are as follows: 1. What are the differences of the functional brain network between autism and TD children? 2. What are the differences of the brain activity in response to special social stimulus between autism and TD children? Participants will receive developmental/intelligence assessments (Griffiths Mental Developmental Scales/Wechsler Preschool and Primary Scale of Intelligence-IV/Wechsler Intelligence Scale for Children-IV for children of different ages), social assessments(Autism Diagnostic Observation Schedule-2nd Edition/Social Communication Questionnaire), EEG/ERPs and fNIRs in resting and task states, and head MRI in natural sleeping state(without sedative).
Detailed description
The cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. The investigators will recruit children aged between 2 to 17 years and 11 months old. They need to receive the mentioned assessments and medical examinations for at least once.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: ADOS-2Subjects in the case group are diagnosed with autism spectrum disorder according to DSM-V and clinical observation. |
| Control group | – | –Subjects in the control group are healthy children without serious chronic or congenital diseases. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The observation study will be performed in children with ASD and healthy, typically developing children.
Key inclusion criteria (6 listed)
- Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
- Ages 2-17 years;
- Parents/caregivers understand the content of the study and agree to participate in.
- Healthy children age between 2 to 17 years.
- Children without the family history of ASD or other neurodevelopmental/mental diseases.
Key exclusion criteria (8 listed)
- Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
- Children with brain injuries, specific chronic or congenital diseases.
- The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
- Children cannot receive the head MRI examination.
- Children with brain injuries, specific chronic or congenital diseases.
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 |
|---|---|---|
| ADOS-2The subjects in case group will receive the ADOS-2 assessment to confirm their diagnosis. | Diagnostic test | Case group |
Primary outcome
clinical diagnosis
Time frame: Baseline (during 2 to 17 years old).
Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2. The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.
Latencies in event related potentials(ERPs)
Time frame: Baseline (during 2 to 17 years old).
The investigators will explore the differences of N1/N2, P3/LPP and N400 in event related potentials (ERPs) between case and control groups (children with ASD and typical development) in responses to special prosocial stimulus, and also in false belief tasks. Event related potentials (ERPs) will be tested using eego™ mylab of ANT Neuro company.
Amplitudes in ERPs
Time frame: Baseline (during 2 to 17 years old).
Amplitudes of N1/N2, P3/LPP and N400 will be compared between children with autism spectrum disorder and typical development.
nuclear magnetic resonance imaging(MRI)
Time frame: Baseline (during 2 to 17 years old).
Cranial MRI data, including sMRI and fMRI, will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Changes in the concentrations of Oxygenated Hemoglobin (HbO) and deoxygenated Hemoglobin (HbR) during interactions
Time frame: Baseline (during 2 to 17 years old).
The investigators will explore inter-group differences of children with ASD and typical development in the concentrations of HbO and HbR during social communication scenes between participants and investigators.
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 29 May 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.
Xiu Xu 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 Spectrum Disorder 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 6 inclusion and 8 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 29 May 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 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 (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: Baseline (during 2 to 17 years 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 29 May 2025.