Studying Childhood-onset Behavioral Psychiatric and Developmental Disorders
-
- STATUS
- Recruiting
-
- End date
- Feb 20, 2022
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- participants needed
- 3500
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- sponsor
- National Institute of Mental Health (NIMH)
Summary
- Background
-
- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they
tend to run in families. Some begin in childhood, while others do not appear until adulthood.
Researchers want to look at people of all ages who have these disorders that started in
childhood. They will also look at relatives of people with these disorders. This information
will allow doctors to learn more about childhood behavioral problems and how they are
inherited. It may also help doctors treat those disorders.
- Objectives
- To study the onset and treatment of childhood behavioral, psychiatric, and developmental
disorders.
- Eligibility
- Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems.
- Family members of individuals with the above disorders. This group may include parents,
grandparents, siblings, aunts/uncles, cousins, and children.
- Design
- Participants will be screened with a medical history and physical exam. They will have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function. They may have a spinal tap to collect cerebrospinal fluid.
- Relatives will have a medical history and physical exam. They will also have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function.
- A relative s exams may reveal a behavioral or other disorder. If so, he or she may re-enroll on the study as a person with the disorder.
- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they
tend to run in families. Some begin in childhood, while others do not appear until adulthood.
Researchers want to look at people of all ages who have these disorders that started in
childhood. They will also look at relatives of people with these disorders. This information
will allow doctors to learn more about childhood behavioral problems and how they are
inherited. It may also help doctors treat those disorders.
Description
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.
- Objectives
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.
Study Population:
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).
- Design
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.
Outcome Measures:
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.
Details
| Clinical Study Identifier | NCT01778504 |
|---|---|
| Sponsor | National Institute of Mental Health (NIMH) |
| Last Modified on | 2 December 2020 |
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