Neurologic DisordersNCT00271622
The Neurodevelopmental and Behavioral Phenotyping Screening Protocol
An observational study of Neurologic Disorders and Autism, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Neurologic Disorders, Autism, Neurodegenerative Disease
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2006to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population consists of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.
Who may be able to join
- 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).
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Neurodevelopmental and Behavioral Phenotyping Screening Protocol
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.
- Keywords
- Developmental Delay, Pediatric, Pervasive Developmental Disorder, Early Development, Healthy Control Subjects, Autism Spectrum Disorders, Healthy Volunteer, HV
- Medical subject headings
- Nervous System Diseases, Autistic Disorder, Neurodegenerative Diseases, Neurobehavioral Manifestations, Learning Disabilities, Child Development Disorders, Pervasive, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | healthy volunteers | |
| individuals at risk | individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study start27 Feb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Genalynne C Mooneyham, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271622
- Sponsor's protocol ID
- 060065
- Other IDs
- 06-M-0065
- Status last verified
- 23 Jun 2026
- First submitted
- 31 Dec 2005
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 31657503Manwaring 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 28120370Swineford 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 25894712Thurm 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 24274034Joseph 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental and Behavioral Phenotyping Screening Protocol
- ClinicalTrials.gov ID
- NCT00271622
- Acronym / sponsor ID
- 060065
- Keywords
- Developmental Delay, Pediatric, Pervasive Developmental Disorder, Early Development, Healthy Control Subjects, Autism Spectrum Disorders, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 27 Feb 2006 (actual)
- First posted
- 2 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | –healthy volunteers |
| individuals at risk | – | –individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population consists of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms
Time frame: Ongoing
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 31657503Farmer 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.
- Derived from this study: PubMed 28120370Manwaring 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.
- Derived from this study: PubMed 25894712Swineford 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.
- Derived from this study: PubMed 24274034Thurm 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.
- Derived from this study: PubMed 23868881Joseph 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Genalynne C Mooneyham, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorders and Autism, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret J Pekar ((301) 402-1084, pekarm@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271622, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.