Protokol til screening af neurodevelopmental og adfærdsmæssig fænotyping
Neuroudviklings- og adfærdsfænotyping-screeningsprotokol
The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.
Studieoversigt
Status
Detaljeret beskrivelse
The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. The evaluations may be used to determine if the participant meets criteria for participation in research protocols at the National Institute of Mental Health (NIMH) and other collaborative investigations. Since the entry criteria for these protocols vary, the screening evaluations will also vary. Behavioral evaluations will also be done through this protocol for individuals participating in IRB-approved protocols being conducted by collaborating scientists at NIH. The evaluations might include: a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms; neuropsychological testing; a medical history; a physical exam; blood; and a request for medical records. Parents of minors will be interviewed.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Genalynne C Mooneyham, M.D.
- Telefonnummer: (301) 435-6651
- E-mail: gena.mooneyham@nih.gov
Undersøgelse Kontakt Backup
- Navn: Margaret J Pekar
- Telefonnummer: (301) 402-1084
- E-mail: pekarm@mail.nih.gov
Studiesteder
-
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- Rekruttering
- National Institutes of Health Clinical Center
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Kontakt:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Telefonnummer: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The population consists of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.
Beskrivelse
- INCLUSION CRITERIA:
- Subjects must be at least 6 weeks of age.
- Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents/guardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.
- Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).
EXCLUSION CRITERIA:
-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians/caretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: OTHER
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
healthy volunteers
healthy volunteers |
|
individuals at risk
individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms
Tidsramme: Ongoing
|
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms |
Ongoing
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Genalynne C Mooneyham, M.D., National Institute of Mental Health (NIMH)
Publikationer og nyttige links
Generelle publikationer
- Farmer C, Adedipe D, Bal VH, Chlebowski C, Thurm A. Concordance of the Vineland Adaptive Behavior Scales, second and third editions. J Intellect Disabil Res. 2020 Jan;64(1):18-26. doi: 10.1111/jir.12691. Epub 2019 Oct 28.
- Manwaring SS, Mead DL, Swineford L, Thurm A. Modelling gesture use and early language development in autism spectrum disorder. Int J Lang Commun Disord. 2017 Sep;52(5):637-651. doi: 10.1111/1460-6984.12308. Epub 2017 Jan 24.
- Swineford LB, Guthrie W, Thurm A. Convergent and divergent validity of the Mullen Scales of Early Learning in young children with and without autism spectrum disorder. Psychol Assess. 2015 Dec;27(4):1364-78. doi: 10.1037/pas0000116. Epub 2015 Apr 20.
- Thurm A, Manwaring SS, Luckenbaugh DA, Lord C, Swedo SE. Patterns of skill attainment and loss in young children with autism. Dev Psychopathol. 2014 Feb;26(1):203-14. doi: 10.1017/S0954579413000874. Epub 2013 Nov 25.
- Joseph L, Thurm A, Farmer C, Shumway S. Repetitive behavior and restricted interests in young children with autism: comparisons with controls and stability over 2 years. Autism Res. 2013 Dec;6(6):584-95. doi: 10.1002/aur.1316. Epub 2013 Jul 18.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Psykiske lidelser
- Neuroudviklingsforstyrrelser
- Kommunikationsforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Autismespektrumforstyrrelse
- Autistisk lidelse
- Sygdomme i nervesystemet
- Neurodegenerative sygdomme
- Neuroadfærdsmæssige manifestationer
- Indlæringsvanskeligheder
- Børns udviklingsforstyrrelser, gennemgående
Andre undersøgelses-id-numre
- 060065
- 06-M-0065
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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