Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD (NCT06329245) | Clinical Trial Compass
RecruitingNot Applicable
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
China100 participantsStarted 2024-04-01
Plain-language 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). 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.
Who can participate
Age range
0 Months – 18 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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;
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.