Studying Childhood-onset Behavioral Psychiatric and Developmental Disorders

  • STATUS
    Recruiting
  • End date
    Feb 20, 2022
  • participants needed
    3500
  • sponsor
    National Institute of Mental Health (NIMH)
Updated on 2 December 2020
brain imaging
behavioral problems
developmental disabilities

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.

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.

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.

Details
Clinical Study IdentifierNCT01778504
SponsorNational Institute of Mental Health (NIMH)
Last Modified on2 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 99 yrs?
Gender: Male or Female
Do you have any of these conditions: Autism or Autism Spectrum Disorder or Autism Spectrum Disorder (ASD) or Neurologic Disorders or nervous system disorder?
Do you have any of these conditions: nervous system disorder or nervous system disease or nervous system disorders or autistic or disorders of the nervous system or Autism Spectrum Disord...?
Do you have any of these conditions: Neurologic Disorders or neurological disease or neurological disorders or Autism Spectrum Disorder (ASD) or nervous system disorder or disorders of th...?
Do you have any of these conditions: neurologic disorder or autistic or neurological disorders or Autism Spectrum Disorder (ASD) or neurological disorder or neurological disease or nervou...?
Do you have any of these conditions: nervous system disease or nervous system disorder or Autism Spectrum Disorder or autistic or neurologic disorder or neurological disease or Autism or ...?
Do you have any of these conditions: neurological disorder or Autism Spectrum Disorder (ASD) or Neurologic Disorders or neurological disorders or nervous system disorder or Autism or nerv...?
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
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