Screening for Studies on Autism Spectrum Disorders

This study is currently recruiting participants.

See

Verified December 5, 2016 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Sponsor:

ClinicalTrials.gov Identifier:

NCT00271622

First Posted: January 2, 2006

Last Update Posted: October 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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) )

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

Detailed Description:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Swineford 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.

Thurm 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.

Joseph 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.


Responsible Party:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00271622 History of Changes
Other Study ID Numbers:	060065 06-M-0065
First Submitted:	December 31, 2005
First Posted:	January 2, 2006
Last Update Posted:	October 6, 2017
Last Verified:	December 5, 2016

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

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