Screening protocol for evaluating neurodevelopmental and behavioral conditions
Neurodevelopmental and Behavioral Phenotyping Screening Protocol
National Institutes of Health Clinical Center (CC) · NCT00271622
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 type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 6 Weeks and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00271622 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals from 6 weeks of age who are either healthy volunteers or at risk for neurodevelopmental or psychiatric disorders.
Not a fit: Patients who do not meet the consent requirements or those without appropriate guardianship may not benefit from this study.
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 performed: Other studies have shown success in using similar screening protocols to identify and evaluate neurodevelopmental disorders, indicating a promising approach.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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) 435-7962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurologic Disorders, Autism, Neurodegenerative Disease, Neurobehavioral Manifestation, Developmental Delay, Pediatric, Pervasive Developmental Disorder, Early Development