- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05795452
Miljøblandinger, kognitiv kontroll og belønningsprosesser, og risiko for psykiatriske problemer i ungdomsårene
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Amy Margolis, PhD
- Telefonnummer: 3472767256
- E-post: amy.margolis@osumc.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University Irving Medical Center
-
Ta kontakt med:
- Julie Herbstman, PhD
- E-post: jh2678@cumc.columbia.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Ungdom fra mødre- og nyfødtkullet
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Youth Self Report (YSR) from the Child Behavior Checklist (CBCL)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Amy Margolis, PhD, Ohio State University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- AAAU9473
- 8191 (Annen identifikator: New York State Psychiatric Institute Institutional Review Board)
- 5R01ES032296-03 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified data will be shared upon written request.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .