Air Pollution and Development in the Boricua Youth Study

August 4, 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Puerto Rico
    • Puerto Rcio
      • San Juan, Puerto Rcio, Puerto Rico, 00921
        • University of Puerto Rico
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York State Psychiatric Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Environmental Health Sciences (NIEHS)
University of Puerto Rico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ligia Chavez, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings