Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any - 99 |
| Updated: | 2/17/2019 |
| Start Date: | January 26, 2013 |
| End Date: | July 6, 2020 |
| Contact: | Susan E Swedo, M.D. |
| Email: | swedos@mail.nih.gov |
| Phone: | (301) 496-5323 |
Diagnosis and Treatment of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders
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.
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.
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.
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.
- INCLUSION CRITERIA:
Participants will be eligible if they:
- Are aged birth to 99 years
- Have a diagnosed or undiagnosed neuropsychiatric disorder, neurodevelopmental
disability or abnormal behaviors; OR are a relative of a participant with one of the
disorders of interest.
- Have the ability to understand and sign an informed consent on behalf of themselves or
their minor children, or have a legal guardian (or designated DPA),Children older than
age 7 years with the capacity to provide assent will be asked to provide written,
informed assent for study participation.
- Are under the care of a primary physician.
EXCLUSION CRITERIA:
Participants will not be eligible if they:
- Are unwilling or unable to be evaluated, treated and followed as clinically indicated.
Examples might include children with severe behavioral problems who refuse physical
examination or individuals with phlebotomy phobias that prohibit blood collection.
- The participant does not have a primary healthcare provider.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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