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The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Recruiting
6 years and older
All
Phase N/A

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Overview

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.

Description

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 may be used to determine if the participant meets criteria for participation in specific research protocols at the National Institute of Mental Health (NIMH) and other collaborative investigations.Since the entry criteria for these protocols vary, inclusion criteria and 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.

Eligibility

  • 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.

Study details
    Neurologic Disorders
    Autism
    Neurodegenerative Disease
    Neurobehavioral Manifestation

NCT00271622

National Institute of Mental Health (NIMH)

25 June 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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