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| Sponsor: | 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: | Screening Protocol for Studies of the Pediatrics and Developmental Neuroscience Branch |
| Estimated Enrollment: | 1100 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
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 Neuropscience Branch (PDN) at the National Institute of Mental Health (NIMH) and other collaborative investigations. This protocol will be the entry point for all 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: | 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. 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| 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: | September 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00271622 History of Changes |
| 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 Pathologic Processes Disease |
Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |
