Participant Database for Autism Research Studies

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Massachusetts General Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00549731

First received: October 15, 2007

Last updated: May 3, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2007

Last Updated Date

May 3, 2010

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00549731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Participant Database for Autism Research Studies

Official Title ^ICMJE

Participant Database for Persons Interested in Autism Research Studies: Recruiting, Pre-Screening and Diagnostic Assessment

Brief Summary

The purpose of this study is to create a subject database to recruit for current and future studies in research on autism and other neurodevelopmental disabilities.

Detailed Description

Aim 1: to recruit people interested in research on autism and other neurodevelopmental disabilities

Aim 2: to complete a diagnostic assessment, to confirm the diagnosis of autism spectrum disorder or other developmental disability (e.g., developmental language delay) in our patient population and rule out a diagnosis of autism spectrum disorder and other comorbid conditions in our control group

Aim 3: to maintain subject information in a database, from which we can recruit for our studies

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adult/Pediatric

Condition ^ICMJE

Autism Spectrum Disorder
Developmental Language Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

5000

Estimated Completion Date

June 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Enrollment will be open to typically-developing, healthy children and adults (ages 0-45), children and adults with autism spectrum disorder (ages 0-45), siblings of children and adults with autism spectrum disorder (ages 0-45), and children and adults with developmental language delays (ages 0-45).

Gender

Both

Ages

up to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Alyssa Orinstein, Rsch Coord

617-766-9766

TRANSCEND@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00549731

Other Study ID Numbers ^ICMJE

2007-P-000062

Has Data Monitoring Committee

Responsible Party

Martha Herbert, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Martha Herbert, MD, Ph.D	Massachusetts General Hospital
Principal Investigator:	Tal Kenet, Ph.D	Massachusetts General Hospital
Principal Investigator:	Katherine Martien, MD	Massachusetts General Hospital/LADDERS

Information Provided By

Massachusetts General Hospital

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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