Air Pollution and Development in the Boricua Youth Study

NCT05368493 | Enrolling By Invitation

• 2 other identifiers: 8232R01ES032870-01
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pollution; Exposure; Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• Frontal lobe and corpus callosum volumes

  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 Outcomes (1)

• Exploratory- Task fMRI (Simon)

  Children will undergo MRI scans when they are 6-11 years of age.

Study Arms (1)

All participants

OTHER

All participants will be in the same arm.

Other: MRI task

Interventions

MRI task OTHER

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.

All participants

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Having serious neurological disorder, excluding ASD (e.g., seizure disorder).
• MRI contraindications (irremovable metal in body like braces, pacemakers).
• Claustrophobia.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• University of Puerto Rico: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Claudia I Lugo-Candelas, PhD

  Columbia University Irving Medical Center/New York State Psychiatric institute

  PRINCIPAL INVESTIGATOR

• Glorisa Canino, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

• Cristiane S Duarte, PhD

  Columbia University Irving Medical Center/New York State Psychiatric institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: January 23, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)