Protocol Number: 06-M-0065

Title:

The Evaluation of Patients with Autism Spectrum Disorders and Healthy Volunteers

Number:

06-M-0065

Summary:

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

Special Instructions:

Currently Not Provided

Keywords:

Screening

Pediatric

Pervasive Developmental Disorder

Early Development

Children

Recruitment Keyword(s):

Autism Spectrum Disorders

Pervasive Developmental Disorder

Healthy Volunteer

HV

Condition(s):

Autism Spectrum Disorders

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Beneke M, Rasmus W. "Clinical Global Impressions" (ECDEU): some critical comments. Pharmacopsychiatry. 1992 Jul;25(4):171-6.

Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43.

Constantino JN, Davis SA, Todd RD, Schindler MK, Gross MM, Brophy SL, Metzger LM, Shoushtari CS, Splinter R, Reich W. Validation of a brief quantitative measure of autistic traits: comparison of the social responsiveness scale with the autism diagnostic interview-revised. J Autism Dev Disord. 2003 Aug;33(4):427-33.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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