Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

  • STATUS
    Recruiting
  • End date
    Feb 20, 2025
  • participants needed
    3500
  • sponsor
    National Institute of Mental Health (NIMH)
Updated on 19 June 2022
brain imaging
behavioral problems
developmental disabilities
Accepts healthy volunteers

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 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.

Details
Condition Neurological Disorder, Autism, Sleep
Clinical Study IdentifierNCT01778504
SponsorNational Institute of Mental Health (NIMH)
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

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)
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note