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Screening for Studies on Autism Spectrum Disorders
This study is currently recruiting participants.
Verified December 5, 2016 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Sponsor:
National Institute of Mental Health (NIMH)
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00271622
First received: December 31, 2005
Last updated: June 30, 2017
Last verified: December 5, 2016
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Purpose
This study will screen children and adolescents (and their parents) to determine the child's eligibility for participation in NIMH research studies on autism spectrum disorders, such as autism and Rett's Disorder.
Screening evaluations include some or all of the following procedures:
Parent interview
Parent and child evaluations including:
- Diagnostic interview
- Developmental or cognitive testing
- Ratings of psychiatric and medical symptoms
- Neuropsychological testing
- Personal, social an family history
Child physical examination and possible blood draw
Children who are determined eligible for a current NIMH research protocol are invited to participate.
| Condition |
|---|
| Autism Spectrum Disorders |
| Study Type: | Observational |
| Official Title: | Screening Protocol for Studies of the Pediatrics and Developmental Neuroscience Branch |
Resource links provided by NLM:
Genetics Home Reference related topics:
autism spectrum disorder
MedlinePlus related topics:
Autism Spectrum Disorder
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
| Estimated Enrollment: | 5000 |
| Study Start Date: | December 29, 2005 |
The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. The evaluations will help determine if the participant meets criteria for participation in research protocols of the Pediatric and Developmental Neuroscience Branch (PDN) at the National Institute of Mental Health (NIMH) and other collaborative investigations. This protocol will be the entry point for PDN 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 in 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. Upon conclusion of the screening process, subjects seeking eligibility for PDN protocols will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be discharged from the protocol.
Eligibility| Ages Eligible for Study: | up to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
- 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 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, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).
EXCLUSION CRITERIA:
- Presence of impairing medical or psychiatric illness
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271622
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271622
Contacts
| Contact: Margaret J Pekar | (301) 402-1084 | pekarm@mail.nih.gov | |
| Contact: Audrey E Thurm, Ph.D. | (301) 496-5323 | at191u@nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
National Human Genome Research Institute (NHGRI)
Investigators
| Principal Investigator: | Audrey E Thurm, Ph.D. | National Institute of Mental Health (NIMH) |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00271622 History of Changes |
| Other Study ID Numbers: |
060065 06-M-0065 |
| Study First Received: | December 31, 2005 |
| Last Updated: | June 30, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
|
Screening Pediatric Pervasive Developmental Disorder Early Development |
Children Autism Spectrum Disorders Healthy Volunteer HV |
Additional relevant MeSH terms:
|
Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive |
Pathologic Processes Neurodevelopmental Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 28, 2017