The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

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.

- 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.