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Air Pollution Exposure and Risk of ADHD in Youth

N/A
Waitlist Available
Led By Glorisa Canino, PhD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One parent must speak English or Spanish.
Speaks English or Spanish.
Must not have
Having serious neurological disorder, excluding ASD (e.g., seizure disorder).
Having a parent that is not competent to consent (e.g., severe intellectual disability would have triggered exclusion) or under 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up children will undergo mri scans when they are 6-11 years of age.
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how air pollution exposure during pregnancy affects a baby's risk for ADHD, and if inflammation & sleep problems during pregnancy play a role. It'll use imaging & a well-studied group of Puerto Ricans to explore this.

Who is the study for?
This study is for children enrolled in the Boricua Youth Study (BYS-ECHO) and their parents who can consent to participation. Participants must speak English or Spanish. It excludes those with serious neurological disorders, MRI contraindications like metal implants, claustrophobia, or if a parent cannot legally consent.
What is being tested?
The trial aims to understand how prenatal air pollution exposure affects the risk of ADHD in offspring by using MRI tasks. It will focus on maternal inflammation during pregnancy and sleep issues in children as potential mechanisms influencing neurodevelopment.
What are the potential side effects?
There are no direct side effects from participating in this study since it involves non-invasive MRI scans; however, individuals with claustrophobia may experience discomfort due to the enclosed nature of MRI machines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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One of my parents speaks English or Spanish.
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I speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious brain or nerve condition, but not autism.
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My parent cannot legally consent due to a severe intellectual disability or being under 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~children will undergo mri scans when they are 6-11 years of age.
This trial's timeline: 3 weeks for screening, Varies for treatment, and children will undergo mri scans when they are 6-11 years of age. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frontal lobe and corpus callosum volumes
Other study objectives
Exploratory- Task fMRI (Simon)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
All participants will be in the same arm.

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
479 Previous Clinical Trials
153,648 Total Patients Enrolled
University of Puerto RicoOTHER
67 Previous Clinical Trials
22,103 Total Patients Enrolled
National Institute of Environmental Health Sciences (NIEHS)NIH
291 Previous Clinical Trials
1,234,266 Total Patients Enrolled
Glorisa Canino, PhDPrincipal InvestigatorUniversity of Puerto Rico
5 Previous Clinical Trials
1,283 Total Patients Enrolled
Claudia I Lugo-Candelas, PhDPrincipal InvestigatorColumbia University Irving Medical Center/New York State Psychiatric institute
Cristiane S Duarte, PhDPrincipal InvestigatorColumbia University Irving Medical Center/New York State Psychiatric institute

Media Library

All participants Clinical Trial Eligibility Overview. Trial Name: NCT05368493 — N/A
Neurodevelopmental Disorder Research Study Groups: All participants
Neurodevelopmental Disorder Clinical Trial 2023: All participants Highlights & Side Effects. Trial Name: NCT05368493 — N/A
All participants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368493 — N/A
~98 spots leftby Jun 2027