Environmental Mixtures, Cognitive Control and Reward Processes, and Risk for Psychiatric Problems in Adolescence

October 30, 2026 updated by: Amy Margolis, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

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.

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 attention deficit/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

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.
Observational

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.
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 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 Locations

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

15 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  • Participation in either the Mothers and Newborns or Sibling/Hermanos Cohort
  • Available prenatal exposure data leveraged from the CCCEH database
  • Ability of subject or parent to understand and the willingness to sign a written informed consent document.
  • For children, informed assent and parental informed consent to participate in the study
  • Males and females; Age 15-23 years old
  • Adolescents and parents must be English- or Spanish-speaking

Exclusion Criteria:

  • Contraindication for MRI as determined by institutionally approved MRI screening questionnaire

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Adolescents from the Mothers and Newborns Cohort

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

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.
Columbia University
National Institute of Environmental Health Sciences (NIEHS)

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: Amy Margolis, PhD, Ohio State University

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.
February 20, 2022

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.
May 1, 2027

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.
May 1, 2027

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).
March 21, 2023

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.
March 21, 2023

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.
April 3, 2023

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.
November 3, 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.
October 30, 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.
October 1, 2026

More Information

Terms related to this study

Keywords

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.
  • AAAU9473
  • 8191 (Other Identifier: New York State Psychiatric Institute Institutional Review Board)
  • 5R01ES032296-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared upon written request.

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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