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The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

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ClinicalTrials.gov Identifier: NCT00271622
Recruitment Status : Recruiting
First Posted : January 2, 2006
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date December 31, 2005
First Posted Date January 2, 2006
Last Update Posted Date October 9, 2019
Actual Study Start Date December 29, 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00271622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Neurodevelopmental and Behavioral Phenotyping Screening Protocol
Official Title The Neurodevelopmental and Behavioral Phenotyping Screening Protocol
Brief Summary

This study will screen children and adolescents (and their parents) to determine the child's eligibility for participation in NIMH research studies on autism spectrum disorders, such as autism and Rett's Disorder.

Screening evaluations include some or all of the following procedures:

Parent interview

Parent and child evaluations including:

  • Diagnostic interview
  • Developmental or cognitive testing
  • Ratings of psychiatric and medical symptoms
  • Neuropsychological testing
  • Personal, social an family history

Child physical examination and possible blood draw

Children who are determined eligible for a current NIMH research protocol are invited to participate.

Detailed Description The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. The evaluations will help determine if the participant meets criteria for participation in research protocols of the Pediatric and Developmental Neuroscience Branch (PDN) at the National Institute of Mental Health (NIMH) and other collaborative investigations. This protocol will be the entry point for PDN 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 in 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. Upon conclusion of the screening process, subjects seeking eligibility for PDN protocols will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be discharged from the protocol.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Autism Spectrum Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 26, 2014)
5000
Original Enrollment
 (submitted: December 31, 2005)
400
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages up to 20 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Audrey E Thurm, Ph.D. (301) 496-5323 at191u@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00271622
Other Study ID Numbers 060065
06-M-0065
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators National Human Genome Research Institute (NHGRI)
Investigators
Principal Investigator: Audrey E Thurm, Ph.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 12, 2019