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RecruitingNCT00271622Updated Sep 29, 2026

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

An observational study in Neurologic Disorders, Autism and Neurodegenerative Disease, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 6 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

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

From the registry’s dates

  • Started Feb 2006; still recruiting 20 years 8 months later.
Updated Sep 29, 2026Study contact changedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
5,000
Ages
6 Weeks and older
Sex
All
01

Study summary

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.

Read the detailed description

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. The evaluations may be used to determine if the participant meets criteria for participation in research protocols at the National Institute of Mental Health (NIMH) and other collaborative investigations. Since the entry criteria for these protocols vary, the screening evaluations will also vary. Behavioral evaluations will also be done through this protocol for individuals participating in IRB-approved protocols being conducted by collaborating scientists at NIH. The evaluations might include: a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms; neuropsychological testing; a medical history; a physical exam; blood; and a request for medical records. Parents of minors will be interviewed.

02

Conditions studied

  • Neurologic Disorders
  • Autism
  • Neurodegenerative Disease
  • Neurobehavioral Manifestation

Keywords

  • Developmental Delay
  • Pediatric
  • Pervasive Developmental Disorder
  • Early Development
  • Healthy Control Subjects
  • Autism Spectrum Disorders
  • Healthy Volunteer
  • HV
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 planned enrollment of 5,000 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
6 Weeks and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The population consists of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.

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

  • Subjects must be at least 6 weeks of age.
  • Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written . Parents/guardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.
  • Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).

Exclusion criteria

EXCLUSION CRITERIA:

-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians/caretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.

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
Other
Time perspective
Cross-sectional
Enrollment
5,000 participants (estimated)

Groups and cohorts

  • healthy volunteers

    healthy volunteers

  • individuals at risk

    individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.

06

What researchers measure

Primary outcomes

  1. Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms

    Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Publications

  • Farmer C, Adedipe D, Bal VH, Chlebowski C, Thurm A. Concordance of the Vineland Adaptive Behavior Scales, second and third editions. J Intellect Disabil Res. 2020 Jan;64(1):18-26. doi: 10.1111/jir.12691. Epub 2019 Oct 28. PubMed 31657503 ↗
  • Manwaring SS, Mead DL, Swineford L, Thurm A. Modelling gesture use and early language development in autism spectrum disorder. Int J Lang Commun Disord. 2017 Sep;52(5):637-651. doi: 10.1111/1460-6984.12308. Epub 2017 Jan 24. PubMed 28120370 ↗
  • Swineford LB, Guthrie W, Thurm A. Convergent and divergent validity of the Mullen Scales of Early Learning in young children with and without autism spectrum disorder. Psychol Assess. 2015 Dec;27(4):1364-78. doi: 10.1037/pas0000116. Epub 2015 Apr 20. PubMed 25894712 ↗
  • Thurm A, Manwaring SS, Luckenbaugh DA, Lord C, Swedo SE. Patterns of skill attainment and loss in young children with autism. Dev Psychopathol. 2014 Feb;26(1):203-14. doi: 10.1017/S0954579413000874. Epub 2013 Nov 25. PubMed 24274034 ↗
  • Joseph L, Thurm A, Farmer C, Shumway S. Repetitive behavior and restricted interests in young children with autism: comparisons with controls and stability over 2 years. Autism Res. 2013 Dec;6(6):584-95. doi: 10.1002/aur.1316. Epub 2013 Jul 18. PubMed 23868881 ↗
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Timeline

1 registry update since Sep 25, 2026

Started Feb 2006 (actual).

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

Registered
Dec 31, 2005
First posted
Jan 2, 2006
StartActual
Feb 27, 2006
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
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.
Contact
Study contact's phone or email changed: •••7962→•••1084. See the current contact
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Contact Study contact's phone or email changed: •••7962→•••1084. See the current contact

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
NCT00271622
Responsible party
Sponsor
First posted
Jan 2, 2006
Start date
Feb 27, 2006
Last update
Sep 29, 2026

Study contacts

Margaret J Pekar
Contact
pekarm@mail.nih.gov
(301) 402-1084
Genalynne C Mooneyham, M.D.
Contact
gena.mooneyham@nih.gov
(301) 435-6651
Genalynne C Mooneyham, 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 ↗

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