Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
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Purpose
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.
| Condition |
|---|
|
Autism Spectrum Disorder Obsessive Compulsive Disorder Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal In Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Global Developmental Delay |
| Study Type: | Observational |
| Official Title: | Diagnosis and Treatment of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders |
- Gain knowledge about the course of specific neurodevelopmental and neuropsychiatric disorders in order to better characterize the natural history of such diseases, which can be used to generate hypotheses for future protocols [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3500 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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.
Contacts and Locations| Contact: Susan E Swedo, M.D. | (301) 496-5323 | swedos@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Susan E Swedo, M.D. | National Institute of Mental Health (NIMH) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) |
| ClinicalTrials.gov Identifier: | NCT01778504 History of Changes |
| Other Study ID Numbers: | 130028, 13-M-0028 |
| Study First Received: | January 26, 2013 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Children and Adolescents Natural History Study Neurodevelopmental Disorders Autism Obsessive Compulsive Disorder |
Additional relevant MeSH terms:
|
Autistic Disorder Developmental Disabilities Obsessive-Compulsive Disorder Child Development Disorders, Pervasive |
Mental Disorders Diagnosed in Childhood Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 22, 2013