Air Pollution and Development in the Boricua Youth Study

February 10, 2026 updated by: Claudia Lugo-Candelas, New York State Psychiatric Institute

Prenatal Air Pollution and Neurodevelopment: a Longitudinal Neuroimaging Study of Mechanisms and Early Risk for ADHD in Puerto Rican Children

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023.

The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 11 years (Child)

Accepts Healthy Volunteers

Yes

Study Population

Participants are parent-offspring dyads that are part of the NIH Environmental influences on Child Health Outcomes (ECHO) BYS study. The Boricua Youth Study is a longitudinal two-generation cohort of Puerto Ricans in the South Bronx, NY (SBx) and in the metropolitan area of San Juan, Puerto Rico.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All participants
All participants will be in the same arm.
Other: MRI task
Task fMRI (Simon) [ Time Frame: Children will undergo MRI scans when they are 6-11 years of age. ] Children will also complete a task, which will allow exploratory analyses of the functionality of attention-related neural circuits. The Simon fMRI task is a non-verbal task equivalent to the Stroop that tests sustained attention and inhibitory control and discriminates children with and without ADHD. Exploratory fMRI time-series data for each participant will be modeled using a general linear model with 3 predictors: congruent correct, incongruent correct, and incorrect. Contrast images for each participant (e.g., incongruent-minus-congruent) will be generated and entered into a group-level random-effects model. Analyses are exploratory, and will focus on frontal lobe activity during each type of trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frontal lobe and corpus callosum volumes
Time Frame: Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.
Frontal lobe and corpus callosum volumes in will be measure in offspring. Bilateral middle frontal cortex and corpus callosum volumes will be used in hypothesis testing.
Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory- Task fMRI (Simon)
Time Frame: Children will undergo MRI scans when they are 6-11 years of age.
Children will also complete a task, which will allow exploratory analyses of the functionality of attention-related neural circuits. The Simon fMRI task is a non-verbal task equivalent to the Stroop that tests sustained attention and inhibitory control and discriminates children with and without ADHD. Exploratory fMRI time-series data for each participant will be modeled using a general linear model with 3 predictors: congruent correct, incongruent correct, and incorrect. Contrast images for each participant (e.g., incongruent-minus-congruent) will be generated and entered into a group-level random-effects model. Analyses are exploratory, and will focus on frontal lobe activity during each type of trial.
Children will undergo MRI scans when they are 6-11 years of age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Environmental Health Sciences (NIEHS)
University of Puerto Rico

Investigators

  • Principal Investigator: Glorisa Canino, PhD, University of Puerto Rico
  • Principal Investigator: Claudia I Lugo-Candelas, PhD, Columbia University Irving Medical Center/New York State Psychiatric institute
  • Principal Investigator: Cristiane S Duarte, PhD, Columbia University Irving Medical Center/New York State Psychiatric institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8232
  • R01ES032870-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified participant level data will be shared as required by NIH's 2003 Data Sharing Policy. The data sharing plan and elements are still being determined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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