Air Pollution and Development in the Boricua Youth Study

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05368493
Status
Enrolling By Invitation

Conditions

  • Neurodevelopmental Disorders
  • Pollution; Exposure

Eligibility Criteria

Sex
ALL
Age
6 Months - 11 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jan 23, 2023
Status verified
Feb 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
182 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: All participants
    All participants will be in the same arm.

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032-

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New York State Psychiatric Institute· New York, NY

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