- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05795452
Miljöblandningar, kognitiv kontroll och belöningsprocesser och risk för psykiatriska problem i tonåren
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Amy Margolis, PhD
- Telefonnummer: 3472767256
- E-post: amy.margolis@osumc.edu
Studieorter
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New York
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New York, New York, Förenta staterna, 10032
- Rekrytering
- Columbia University Irving Medical Center
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Kontakt:
- Julie Herbstman, PhD
- E-post: jh2678@cumc.columbia.edu
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
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Ungdomar från mödrar och nyfödda kohorten
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Youth Self Report (YSR) from the Child Behavior Checklist (CBCL)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Amy Margolis, PhD, Ohio State University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- AAAU9473
- 8191 (Annan identifierare: New York State Psychiatric Institute Institutional Review Board)
- 5R01ES032296-03 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
De-identified data will be shared upon written request.
Läkemedels- och apparatinformation, studiedokument
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