- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00271622
신경 발달 및 행동 표현형 스크리닝 프로토콜
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Genalynne C Mooneyham, M.D.
- 전화번호: (301) 435-6651
- 이메일: gena.mooneyham@nih.gov
연구 연락처 백업
- 이름: Margaret J Pekar
- 전화번호: (301) 402-1084
- 이메일: pekarm@mail.nih.gov
연구 장소
-
-
Maryland
-
Bethesda, Maryland, 미국, 20892
- 모병
- National Institutes of Health Clinical Center
-
연락하다:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- 전화번호: TTY dial 711 800-411-1222
- 이메일: ccopr@nih.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The population consists of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
|
healthy volunteers
healthy volunteers |
|
individuals at risk
individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms
기간: Ongoing
|
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms |
Ongoing
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Genalynne C Mooneyham, M.D., National Institute of Mental Health (NIMH)
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 060065
- 06-M-0065
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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