Air Pollution and Development in the Boricua Youth Study (NCT05368493) | Clinical Trial Compass
By InvitationNot Applicable
Air Pollution and Development in the Boricua Youth Study
United States182 participantsStarted 2023-01-23
Plain-language summary
This study seeks to understand the relationship between prenatal maternal air pollution exposure and offspring risk for ADHD and examine two potential -modifiable- mechanisms: prenatal maternal inflammation and offspring sleep problems. We will employ a longitudinal neuroimaging study design and leverage a well-characterized intergenerational cohort of Puerto Ricans to address prior literature's limitations. This will be the first study to use infant neuroimaging to disassociate the effects of prenatal pollution exposure from those of postnatal pollution exposure, adversity and disadvantage, and offspring genetic risk for ADHD.
Who can participate
Age range
6 Months – 11 Years
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.
Inclusion Criteria:
* Having been enrolled in the BYS-ECHO birth cohort (parent study).
* Speaks English or Spanish.
* Having a parent that is eligible to participate, based on criterial detailed below, and agrees to participation.
* One parent must speak English or Spanish.
Exclusion Criteria:
* Having serious neurological disorder, excluding ASD (e.g., seizure disorder).
* MRI contraindications (irremovable metal in body like braces, pacemakers).
* Claustrophobia.
* Having a parent that is not competent to consent (e.g., severe intellectual disability would have triggered exclusion) or under 18 years of age.
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.
What they're measuring
1
Frontal lobe and corpus callosum volumes
Timeframe: Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.