Participant Database for Autism Research Studies | NCT00549731

Studies
Participant Database for Autism Research Studies

NCT00549731

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Apr 24, 2026Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01MH117998	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013Actual

Primary Completion Date

Jun 2023Actual

Completion Date

Jun 2023Actual

First Submitted Date

Oct 15, 2007

First Submission Date that Met QC Criteria

Oct 25, 2007

First Posted Date

Oct 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tal Kenet, Associate Professor, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy individuals		No intervention Healthy participants ages 14-32 for a neuroimaging study.
Individuals with Autism Spectrum Disorder		No intervention ASD participants ages 14-32 for a neuroimaging study.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Typically-developing, healthy adolescents and adults (ages 14-32)
Adolescents and adults with autism spectrum disorder (ages 14-32)

Exclusion Criteria:

Extreme premature birth (<34 weeks)
Known genetic disorders related to autism (e.g. Fragile X)
Recent diagnosis of psychosis (within 6 months)
Some other psychiatric diagnoses may be excluded following screening (e.g. Tourette's syndrome).
Metal implants / permanent retainers / hair dyes with metallic components

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

32 Years

Standard Ages

ChildAdult

Study Population

Adult/Pediatric

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tal Kenet, Ph.D	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Martinos Center of Biomedical Imaging		Charlestown	Massachusetts	02129	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Feb 18, 2022	Aug 10, 2022	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D001321	Autistic Disorder
D007802	Language

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D003142	Communication

Browse Leaves

Not provided

Browse Branches

Not provided