Air Pollution Exposure and Risk of ADHD in Youth

Overseen By Cristiane S Duarte, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Disqualifiers: Neurological disorder, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

182 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does air pollution exposure treatment differ from other ADHD treatments?

This treatment is unique because it focuses on reducing exposure to air pollution, which is a potential risk factor for ADHD, rather than using medication or behavioral therapy. It aims to prevent or mitigate ADHD symptoms by addressing environmental factors, which is different from traditional treatments that typically involve managing symptoms after they appear. ^{1 2 3 4 5}

Research Team

Claudia I Lugo-Candelas, PhD

Principal Investigator

Columbia University Irving Medical Center/New York State Psychiatric institute

Glorisa Canino, PhD

Principal Investigator

University of Puerto Rico

Cristiane S Duarte, PhD

Principal Investigator

Columbia University Irving Medical Center/New York State Psychiatric institute

Eligibility Criteria

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.

Inclusion Criteria

Having a parent that is eligible to participate, based on criterial detailed below, and agrees to participation.

Having been enrolled in the BYS-ECHO birth cohort (parent study).

Exclusion Criteria

You are afraid of enclosed spaces.

I have a serious brain or nerve condition, but not autism.

You cannot have an MRI if you have braces or a pacemaker because they contain metal that cannot be removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neuroimaging Study

Participants undergo neuroimaging to assess the impact of prenatal air pollution exposure on neurodevelopment

6-11 years

Multiple visits for MRI scans

Follow-up

Participants are monitored for neurodevelopmental outcomes and ADHD risk

Long-term

Treatment Details

Interventions

• MRI task

Trial Overview 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.

Participant Groups

Group I: All participants Experimental Treatment 1 Intervention

All participants will be in the same arm.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

University of Puerto Rico

Collaborator

Trials

69

Recruited

22,300+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Air pollutants and attention deficit hyperactivity disorder medication administration in elementary schools. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

PM2.5 exposure and incident attention-deficit/hyperactivity disorder during the prenatal and postnatal periods: A birth cohort study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain: Project Protocol. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Association between short-term air pollution exposure and attention-deficit/hyperactivity disorder-related hospital admissions among adolescents: A nationwide time-series study. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Association between Exposure to Particulate Matter Air Pollution during Early Childhood and Risk of Attention-Deficit/Hyperactivity Disorder in Taiwan. [2022]