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
: April 4, 2018
|
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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.
Condition or disease |
---|
Autism Spectrum Disorders |
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Official Title: | The Neurodevelopmental and Behavioral Phenotyping Screening Protocol |
Study Start Date : | December 29, 2005 |


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Ages Eligible for Study: | up to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271622
Contact: Audrey E Thurm, Ph.D. | (301) 496-5323 | at191u@nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Audrey E Thurm, Ph.D. | National Institute of Mental Health (NIMH) |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00271622 History of Changes |
Other Study ID Numbers: |
060065 06-M-0065 |
First Posted: | January 2, 2006 Key Record Dates |
Last Update Posted: | April 4, 2018 |
Last Verified: | March 28, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Screening Pediatric Pervasive Developmental Disorder Early Development |
Children Autism Spectrum Disorders Healthy Volunteer HV |
Additional relevant MeSH terms:
Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |