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Screening for Studies on Autism Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00271622
First received: December 31, 2005
Last updated: November 11, 2014
Last verified: March 2014

December 31, 2005
November 11, 2014
December 2005
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Complete list of historical versions of study NCT00271622 on ClinicalTrials.gov Archive Site
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Screening for Studies on Autism Spectrum Disorders
Screening Protocol for Studies of the Pediatrics and Developmental Neuroscience Branch

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.

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 all 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.

Observational
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Autism Spectrum Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
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  • 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, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).

EXCLUSION CRITERIA:

Presence of impairing medical or psychiatric illness

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.

Both
up to 20 Years
Yes
Contact: Margaret J Pekar (301) 402-1084 pekarm@mail.nih.gov
Contact: Audrey E Thurm, Ph.D. (301) 496-5323 at191u@nih.gov
United States
 
NCT00271622
060065, 06-M-0065
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National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
National Institute of Mental Health (NIMH)
National Human Genome Research Institute (NHGRI)
Principal Investigator: Audrey E Thurm, Ph.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP