- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05795452
Environmental Mixtures, Cognitive Control and Reward Processes, and Risk for Psychiatric Problems in Adolescence
February 23, 2026 updated by: Ohio State University
This study aims to examine the cognitive and neural pathways underlying the joint impact of chemical and social exposures on two aspects of cognitive function: cognitive control and reward processing.
The investigators will use high resolution, multi-band resting state and task functional magnetic resonance imaging (fMRI) as well as neuromelanin stain MRI to identify pathways through which exposure to a mixture of prenatal chemical and early life social exposures alters brain function and behavior.
Specifically, the investigators will leverage extant prenatal exposure data (N=550) from the Columbia Center for Children's Environmental Health (CCCEH) Mothers and Newborns (MN) birth cohort and study symptoms and brain function in adolescence.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Adolescence is a period of high risk for the emergence of psychiatric issues, particularly attention problems, substance abuse, and psychotic experiences.
Risk for these problems likely originates in the prenatal period when the brain undergoes significant rapid change, making this a particularly vulnerable time for alterations in brain development.
Few studies have examined risk from prenatal exposure to neurotoxicants that emerge in adolescence and the biological pathways that underlie these associations.
Emerging findings suggest that prenatal exposure to environmental chemicals (e.g.
environmental tobacco smoke (ETS), air pollutants such as polycyclic aromatic hydrocarbons (PAH)) is associated with behavioral symptoms of attentiondeficit/ hyperactivity disorder (ADHD), substance use disorders (SUD), and psychotic disorders (PD).
These symptoms often emerge across adolescence, and frequently co-occur, suggesting shared underlying causes in the brain.
Prenatal chemical exposures often co-occur with each other and with social exposures, such as early life stress (ELS) that are also associated with elevated behavioral symptoms.
The joint contributions of these chemical and social exposures to these behavioral symptoms are understudied, as are the cognitive and neural pathways linking exposure to behavior.
Study Type
Observational
Enrollment (Estimated)
250
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
-
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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-
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
13 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The current proposed study is funded to conduct resting state and task fMRI and assessment of psychiatric symptoms in 250 adolescents in the Mothers and Newborns birth cohort.
Prenatal exposure data will be leveraged from the CCCEH database.
Description
Inclusion Criteria:
- Adolescents between 13-20 years
- Available prenatal exposure data
- Adolescents and parents are English- or Spanish-speaking
Exclusion Criteria:
- Presence of metallic device or dental braces
- Full Scale Intelligence Quotient (IQ) < 70 at prior assessment
- Pregnant women or lactating women
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Adolescents from the Mothers and Newborns Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Youth Self Report (YSR) from the Child Behavior Checklist (CBCL)
Time Frame: 15 minutes during study visit
|
This is a 112-question scale for adolescents about their own behavioral functioning.
It has a Likert-like scoring format and multiple syndrome and DSM-oriented scales, with higher scores indicating more symptoms.
Raw scores are converted to T scores with a mean of 50 and standard deviation of 10.
The range is 0 to 90.
|
15 minutes during study visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Margolis, PhD, Ohio State University
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)
February 20, 2022
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 23, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAU9473
- 8191 (Other Identifier: New York State Psychiatric Institute Institutional Review Board)
- 5R01ES032296-03 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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