Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2013 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | November 2012 | ||||
| Estimated Primary Completion Date | July 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01778504 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders | ||||
| Official Title ICMJE | Diagnosis and Treatment of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders | ||||
| Brief 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:
Design:
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| Detailed 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3500 | ||||
| Estimated Completion Date | July 2016 | ||||
| Estimated Primary Completion Date | July 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Participants will be eligible if they:
EXCLUSION CRITERIA: Participants will not be eligible if they:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01778504 | ||||
| Other Study ID Numbers ICMJE | 130028, 13-M-0028 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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