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

Psychiatric Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05795452
• Other study ID #: 8191
• Secondary ID: 5R01ES032296-02
• Status: Suspended
• Start date: February 20, 2022
• Est. completion date: May 2026

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 250
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychiatric Problem

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes during study visit