ClinicalTrials.gg
CompletedNCT01778504Updated Oct 26, 2026

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

An observational study in Neuropsychiatric Disorder, Neurological Disorder and Neurodevelopmental Disorder, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Open to participants aged 30 Days to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Institute of Mental Health (NIMH) · Observational

Updated Oct 8, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
237
Ages
30 Days to 99 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Neuropsychiatric Disorder
  • Neurological Disorder
  • Neurodevelopmental Disorder
  • Sleep

Keywords

  • Natural History Study
  • Mental Illness
  • Autism
  • Developmental Delay
  • Genetic Disorder
  • Natural History
03

In context

Nervous System Diseases

757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.

This study's enrollment of 237 is above the median of 150 across 228 observational studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Days to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Up to 1000 people with psychiatric, behavioral, or developmental disorders will be enrolled in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 on behalf of themselves, or have a legal guardian (or designated DPA).
  4. Are under the care of a primary physician.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
237 participants (actual)

Groups and cohorts

  • Probands

    Children, adolescents, and adults

  • Relatives of Probands

    1st, 2nd, and 3rd degree relatives

06

What researchers measure

Primary outcomes

  1. clinical assessments

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

    Time frame: Ongoing

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Beneke M, Rasmus W. "Clinical Global Impressions" (ECDEU): some critical comments. Pharmacopsychiatry. 1992 Jul;25(4):171-6. doi: 10.1055/s-2007-1014401. PubMed 1528956 ↗
  • Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. doi: 10.1023/a:1005596502855. PubMed 11055459 ↗
  • Constantino JN, Davis SA, Todd RD, Schindler MK, Gross MM, Brophy SL, Metzger LM, Shoushtari CS, Splinter R, Reich W. Validation of a brief quantitative measure of autistic traits: comparison of the social responsiveness scale with the autism diagnostic interview-revised. J Autism Dev Disord. 2003 Aug;33(4):427-33. doi: 10.1023/a:1025014929212. PubMed 12959421 ↗
  • Witmer C, Mattingly A, D'Souza P, Thurm A, Hadigan C. Incontinence in Phelan-McDermid Syndrome. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):e39-e42. doi: 10.1097/MPG.0000000000002342. PubMed 30921255 ↗
  • Khan OI, Zhou X, Leon J, Kessler R, Gaughan T, D'Souza P, Gropman A, Cohen N, Rennert O, Buckley A, Inati S, Thurm A. Prospective longitudinal overnight video-EEG evaluation in Phelan-McDermid Syndrome. Epilepsy Behav. 2018 Mar;80:312-320. doi: 10.1016/j.yebeh.2017.11.034. Epub 2018 Feb 3. PubMed 29402632 ↗
  • Soorya L, Leon J, Trelles MP, Thurm A. Framework for assessing individuals with rare genetic disorders associated with profound intellectual and multiple disabilities (PIMD): the example of Phelan McDermid Syndrome. Clin Neuropsychol. 2018 Aug-Oct;32(7):1226-1255. doi: 10.1080/13854046.2017.1413211. Epub 2017 Dec 21. PubMed 29265961 ↗
  • Gaughan T, Buckley A, Hommer R, Grant P, Williams K, Leckman JF, Swedo SE. Rapid Eye Movement Sleep Abnormalities in Children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). J Clin Sleep Med. 2016 Jul 15;12(7):1027-32. doi: 10.5664/jcsm.5942. PubMed 27166296 ↗
09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2012 to primary completion in Jul 2025, 150 months.

Of 97 non-industry observational studies under Nervous System Diseases, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 150. This study's 150 months is above that.

Counting every sponsor, half of 114 studies reached it within 53 months; a quarter within 20 and three quarters within 121.

Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

Primary completion moved once since we started tracking on Sep 25, 2026: Feb 2029 → Jul 2025, on Oct 8, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2013
First posted
Jan 29, 2013
StartActual
Dec 27, 2012
Primary completionActual
Jul 24, 2025was Feb 2029
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 8, 2026
Primary completion
Feb 20, 2029→Jul 24, 2025 (actual)
Oct 8, 2026
Enrollment
1000 (estimated)→237 (actual)
Oct 8, 2026
Eligibility
Revised
Oct 8, 2026
Show all 3 updates
  1. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 16, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 8, 2026
    Recruiting→Completed
    Primary completion Feb 20, 2029→Jul 24, 2025 (now actual)
    Enrollment 1000 (estimated)→237 (actual)
    Eligibility Revised
    + 4 other changes: verification date, contact details, site details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01778504
Responsible party
Sponsor
First posted
Jan 29, 2013
Start date
Dec 27, 2012
Primary completion
Jul 24, 2025
Last update
Oct 26, 2026

Study contacts

Ashura W Buckley, M.D.
principal investigator · National Institute of Mental Health (NIMH)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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