Psychiatric ProblemNCT05795452
Environmental Mixtures, Cognitive Control and Reward Processes, and Risk for Psychiatric Problems in Adolescence
An observational study of Psychiatric Problem, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 23 years
- Conditions the study is for
- Psychiatric Problem
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2022to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Contraindication for MRI as determined by institutionally approved MRI screening questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Julie Herbstman, PhD, jh2678@cumc.columbia.edu
About this study
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.
Read the 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.
- Conditions
- Psychiatric Problem
- Keywords
- Functional magnetic resonance imaging (fMRI), Cognitive function, Cognitive Control, Reward Processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents from the Mothers and Newborns Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth Self Report (YSR) from the Child Behavior Checklist (CBCL)
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.
Measured: 15 minutes during study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start20 Feb 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric ProblemStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Columbia University
- Responsible party
- Principal investigator, Amy Margolis, Ohio State University
- Investigators
- Amy Margolis, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795452
- Sponsor's protocol ID
- AAAU9473
- Other IDs
- 5R01ES032296-03, 8191
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon written request.
Publications
Benavides J, Cohen JW, Chillrud LG, Cohen G, DeSerisy M, Ramphal B, Goldsmith J, Kioumourtzoglou MA, Margolis AE. Prenatal environmental risk for adolescent attention, thought, and substance use problems: A mixtures approach to coexposure and psychiatric comorbidities. Environ Epidemiol. 2025 Sep 5;9(5):e417. doi: 10.1097/EE9.0000000000000417. eCollection 2025 Oct.
PubMed 40927249
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Mixtures, Cognitive Control and Reward Processes, and Risk for Psychiatric Problems in Adolescence
- ClinicalTrials.gov ID
- NCT05795452
- Acronym / sponsor ID
- AAAU9473
- Conditions
- Psychiatric Problem
- Keywords
- Functional magnetic resonance imaging (fMRI), Cognitive function, Cognitive Control, Reward Processing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Columbia University
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents from the Mothers and Newborns Cohort | – | – |
Who may qualify
- Ages
- 15 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication for MRI as determined by institutionally approved MRI screening questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Results publication: PubMed 40927249Benavides J, Cohen JW, Chillrud LG, Cohen G, DeSerisy M, Ramphal B, Goldsmith J, Kioumourtzoglou MA, Margolis AE. Prenatal environmental risk for adolescent attention, thought, and substance use problems: A mixtures approach to coexposure and psychiatric comorbidities. Environ Epidemiol. 2025 Sep 5;9(5):e417. doi: 10.1097/EE9.0000000000000417. eCollection 2025 Oct.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon written request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Margolis, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Problem, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Margolis, PhD (3472767256, amy.margolis@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Self Report (YSR) from the Child Behavior Checklist (CBCL) (time frame: 15 minutes during study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05795452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.