- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05795452
Omgevingsmengsels, cognitieve controle en beloningsprocessen en risico op psychiatrische problemen in de adolescentie
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Amy Margolis, PhD
- Telefoonnummer: 3472767256
- E-mail: amy.margolis@osumc.edu
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University Irving Medical Center
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Contact:
- Julie Herbstman, PhD
- E-mail: jh2678@cumc.columbia.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
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Adolescenten uit het Cohort Moeders en Pasgeborenen
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Youth Self Report (YSR) from the Child Behavior Checklist (CBCL)
Tijdsspanne: 15 minutes during study visit
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Amy Margolis, PhD, Ohio State University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- AAAU9473
- 8191 (Andere identificatie: New York State Psychiatric Institute Institutional Review Board)
- 5R01ES032296-03 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
De-identified data will be shared upon written request.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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