Participant Database for Autism Research Studies - Tabular View

Tracking Information

First Received Date ^ICMJE

October 15, 2007

Last Updated Date

September 25, 2009

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Autism Spectrum Disorder
Developmental Language Disorders

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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, Research Coordinator

617-766-9766

TRANSCEND@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00549731

Responsible Party

Martha Herbert, Massachusetts General Hospital

Study ID Numbers ^ICMJE

2007-P-000062

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

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

September 2009

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