This is a diagnostic and treatment protocol designed to provide opportunities for identifying new clinical syndromes, providing cases for instruction and training, and permitting longitudinal assessments of a variety of childhood behavioral, psychiatric and developmental disorders. Disorders of particular interest are: autism, disorders of social cognition and other neurodevelopmental disorders; childhood psychiatric disorders and particularly those with acute symptom onset; and unique clinical presentations of pediatric behavioral syndromes, such as those associated with genetic disorders or those with a unique family history.
The primary objective of this protocol is to evaluate a variety of behavioral, neuropsychiatric and neurodevelopmental conditions. Assessing and treating participants will allow the PDN clinicians to maintain their clinical expertise and will provide opportunities for training. Further, the protocol will allow PDN investigators to gain additional knowledge about the course of various childhood behavioral syndromes and their response to standard therapies. The information obtained is expected to generate questions to be answered and hypotheses to be tested in future protocols. In some cases, blood, cerebrospinal fluid or other biologic samples (including urine, saliva and cheek swabs) obtained for clinical studies will be stored for future laboratory studies.
The number of participants to be enrolled will be set at 3,500 participants to permit inclusion of up to 1,000 probands (children, adolescents and adults) and their relatives (n = 2,500 to include key 2nd and 3rd degree relatives, as well as 1st degree relatives).
This is a natural history, treatment and training protocol. The cross-sectional portion of this study will include in-depth medical and laboratory assessments to evaluate the relationship of biological abnormalities with neuropsychiatric symptomatology. Family members will be studied to elucidate the nature of any genetic abnormalities observed in the probands. Clinically useful information (performed in a CLIA certified lab) will be shared with all participants. Standard therapeutic interventions may be utilized to evaluate their effects in well-characterized participants with unique clinical presentations. Participants also may be asked to return to NIH for periodic follow-up assessments, in order to facilitate the longitudinal assessment of natural and treated courses of illness as a means of better understanding their progression and pathophysiology.
No formal outcomes will be measured; however the clinical assessments of enrolled participants may be used to evaluate correlates of clinical symptomatology and response to standard therapeutic interventions. In addition, DNA samples may be obtained from participants and their relatives, in order to identify or verify causative genetic abnormalities in order to establish pathogenic mechanisms and genotype-phenotype correlations.
|Clinical Study Identifier||NCT01778504|
|Sponsor||National Institute of Mental Health (NIMH)|
|Last Modified on||2 December 2020|
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