Recruiting

Observational Study

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT01778504

Conditions

Neuropsychiatric Disorder

Neurological Disorder

Neurodevelopmental Disorder

Sleep

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Study Details

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 may have a psychiatric history with tests of thinking, judgment, and behavior.

Conditions

Neuropsychiatric Disorder

Neurological Disorder

Neurodevelopmental Disorder

Sleep

Study ID

NCT01778504

Start date

Dec 27, 2012

Status verified date

Aug 17, 2026

Primary completion date

Feb 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

Participants will be eligible if they:

1. Are 30 days to 99 years old.
2. 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.
3. Have the ability to understand and sign an informed consent on behalf of themselves, 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:

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Probands

Children, adolescents, and adults

Relatives of Probands

1st, 2nd, and 3rd degree relatives

Primary outcome measure

  • clinical assessments [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

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

(301) 435-7958jessica.vaughan@nih.gov

Ashura W Buckley, M.D.

(301) 496-5190shu.buckley@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

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

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Aug 24, 2026

Last verified

Aug 17, 2026

Keywords

  • Natural History Study
  • Mental Illness
  • Autism
  • Developmental Delay
  • Genetic Disorder
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-08-24.