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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00271622 |
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:
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: | The Evaluation of Patients With Autism Spectrum Disorders and Healthy Volunteers |
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2005 |
The purpose of this protocol is to allow for the careful screening of children and adolescents with autism spectrum disorders and healthy pediatric volunteers in order to determine if they meet criteria for participation in research protocols of the Pediatric and Developmental Neuropsychiatry Branch (PDN) at the National Institute of Mental Health (NIMH) and other collaborative investigations. Subjects will be considered for a series of protocols. Those in this screening protocol will undergo an evaluation which may 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 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. The current protocol thus serves as an entry point to NIMH IRB-approved PDN protocols for individuals with autism spectrum disorders and for healthy volunteers.
Eligibility| Ages Eligible for Study: | 1 Year to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. 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 in the pediatric subject
Lack of parental consent: Whether the minor lives with both parents or one parent, the parent(s) he/she lives with must have legal custody. If a parent has shared custody, both parents must consent to participate in this protocol.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 060065, 06-M-0065 |
| Study First Received: | December 31, 2005 |
| Last Updated: | December 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00271622 |
| Health Authority: | United States: Federal Government |
|
Screening Pediatric Pervasive Developmental Disorder Early Development Children |
Autism Spectrum Disorders Pervasive Developmental Disorder Healthy Volunteer HV |
|
Child Development Disorders, Pervasive Developmental Disabilities Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Healthy |
|
Pathologic Processes Disease |
