Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

This study is currently recruiting participants.
Verified June 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT01778504
First received: January 26, 2013
Last updated: March 14, 2014
Last verified: June 2013

January 26, 2013
March 14, 2014
November 2012
July 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01778504 on ClinicalTrials.gov Archive Site
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Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
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.

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.

Observational
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  • Autism Spectrum Disorder
  • Obsessive Compulsive Disorder
  • Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal In
  • Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
  • Global Developmental Delay
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3500
July 2016
July 2016   (final data collection date for primary outcome measure)
  • 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.
Both
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Contact: Susan E Swedo, M.D. (301) 496-5323 swedos@mail.nih.gov
United States
 
NCT01778504
130028, 13-M-0028
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National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
National Institute of Mental Health (NIMH)
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Principal Investigator: Susan E Swedo, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP