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Recruiting

NCT Number: NCT01778504

Studying Childhood-onset Behavioral, Psychiatric, and Developmental 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 may have a psychiatric history with tests of thinking, judgment, and behavior....

Recruiting

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Key information

Age range

30 day–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

CONTACT

[email protected]

800-411-1222 ext. TTY dial 711

About this study

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 up to 1,000 probands (children, adolescents and adults).

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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

Participants will be eligible if they:

  • Are 30 days to 99 years old.
  • Either:

-Have a diagnosed neuropsychiatric disorder or neurodevelopmental disability or related symptoms without a formal diagnosis

OR

-Are a biological relative of someone who meets the criteria above.

  • Have the ability to understand and sign an informed consent on behalf of themselves, 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.

Treatment and study plan

Primary outcomes

  1. clinical assessments

    Time frame: Ongoing

    to evaluate correlates of clinical symptomatology and response to standard therapeutic interventions.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashura W Buckley, M.D.

CONTACT

[email protected]

(301) 496-5190

Jessica M Vaughan, C.R.N.P.

CONTACT

[email protected]

(301) 435-7958

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health (NIMH)

Nih

Registry information

Official study title

Diagnosis of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders

Important dates

Study start
2012
Primary completion
2029
First posted
Jan 29, 2013
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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