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Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

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ClinicalTrials.gov Identifier: NCT01778504
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

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:

  • 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 or disease
Neurological Disorder Autism Sleep

Detailed Description:

This is a diagnostic protocol designed to provide opportunities for identifying new clinical syndromes 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. The protocol will allow OCD investigators to gain additional knowledge about the course of various childhood behavioral syndromes. The information obtained is expected to generate questions to be answered and hypotheses to be tested in future protocols.

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 protocol. The cross-sectional portion of this study may include in-depth medical, sleep and neurodevelopmental assessments to evaluate the relationship of biological abnormalities with neuropsychiatric symptomatology. Family members may be studied to elucidate the nature of any genetic abnormalities observed in the probands. Clinically useful information 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.

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Treatment of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders
Actual Study Start Date : December 27, 2012
Estimated Primary Completion Date : February 20, 2025
Estimated Study Completion Date : February 20, 2025

Group/Cohort
Probands
Children, adolescents, and adults
Relatives of Probands
1st, 2nd, and 3rd degree relatives



Primary Outcome Measures :
  1. clinical assessments [ Time Frame: Ongoing ]
    to evaluate correlates of clinical symptomatology and response to standard therapeutic interventions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).
Criteria
  • INCLUSION CRITERIA:

Participants will be eligible if they:

  1. Are aged birth to 99 years
  2. 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.
  3. 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).
  4. Are under the care of a primary physician.

EXCLUSION CRITERIA:

Participants will not be eligible if they:

  • Are unwilling or unable to be evaluated and followed as clinically indicated. Examples might include children with severe behavioral problems who refuse physical examination.
  • The participant does not have a primary healthcare provider.

Subjects participating in this study may be recruited by other NIH investigators to co-enroll in separate correlative NIH studies for which they would sign separate consent forms if interested. Data will be shared between protocols. Of note, samples will be clinically annotated.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778504


Contacts
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Contact: Audrey E Thurm, Ph.D. (301) 496-5323 athurm@mail.nih.gov
Contact: Ashura W Buckley, M.D. (301) 496-5190 shu.buckley@nih.gov

Locations
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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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Ashura W Buckley, M.D. National Institute of Mental Health (NIMH)
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01778504    
Other Study ID Numbers: 130028
13-M-0028
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: January 6, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Natural History Study
Mental Illness
Autism
Developmental Delay
Genetic Disorder
Additional relevant MeSH terms:
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Nervous System Diseases
Disease
Pathologic Processes