The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

NCT00271622 | Recruiting

• 2 other identifiers: 06006506-M-0065
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

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

Outcome Measures

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

  Ongoing

Study Arms (2)

healthy volunteers

healthy volunteers

individuals at risk

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

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 informed consent. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 31657503 DERIVED

• 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.

  PMID: 28120370 DERIVED

• 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.

  PMID: 25894712 DERIVED

• 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.

  PMID: 24274034 DERIVED

• 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.

  PMID: 23868881 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Nervous System Diseases; Autistic Disorder; Neurodegenerative Diseases; Neurobehavioral Manifestations; Learning Disabilities; Child Development Disorders, Pervasive; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication Disorders

Study Officials

• Genalynne C Mooneyham, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret J Pekar

CONTACT

(301) 435-7962; pekarm@mail.nih.gov

Genalynne C Mooneyham, M.D.

CONTACT

(301) 435-6651; gena.mooneyham@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2005
• First Posted: January 2, 2006
• Study Start: February 27, 2006
• Last Updated: May 7, 2026

Record last verified: 2025-12-10

Locations

US (1)