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Clinical trial Recruiting at 1 site Observational Ages 6 Weeks and up

Screening protocol for evaluating neurodevelopmental and behavioral conditions

Official title: Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Run by National Institutes of Health Clinical Center (CC) · NCT00271622 · Data updated 2026-11-12

This study is testing a new way to check for neurodevelopmental and behavioral conditions in healthy volunteers and those at risk, like autism, to see if they can join future research at the National Institute of Mental Health.

Quick facts

Study typeObservational
Ages6 Weeks and up
SexAll
Enrollment5000 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedFebruary 27, 2006
Registry record updatedSeptember 29, 2026
Trial IDNCT00271622 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals from 6 weeks of age who are either healthy volunteers or at risk for neurodevelopmental or psychiatric disorders.

Probably not a fit

Patients who do not meet the consent requirements or those without appropriate guardianship may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This protocol aims to evaluate healthy volunteers and individuals at risk for psychiatric or neurodevelopmental disorders, such as autism spectrum disorder. Participants will undergo a variety of assessments, including psychiatric interviews, cognitive testing, and medical evaluations, to determine eligibility for further research protocols at the National Institute of Mental Health (NIMH). The evaluations will vary based on the specific research protocols and may involve collaboration with other scientists at NIH.

Why it matters

Potential benefit: If successful, this protocol could enhance the understanding and early identification of neurodevelopmental disorders, leading to better-targeted interventions.

How similar studies have gone: Other studies have shown success in using similar screening protocols to identify and evaluate neurodevelopmental disorders, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States     Recruiting

Study contacts

  • Principal investigator: Genalynne C Mooneyham, M.D. — National Institute of Mental Health (NIMH)
  • Study coordinator: Margaret J Pekar
  • Email: pekarm@mail.nih.gov
  • Phone: (301) 402-1084

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.