NCT00910559

Brief Summary

The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2008Feb 2030

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
18.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

December 29, 2025

Status Verified

February 1, 2025

Enrollment Period

19.5 years

First QC Date

May 29, 2009

Last Update Submit

December 26, 2025

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum DisorderAutismAsperger SyndromePervasive Developmental Disorders- Not Otherwise Specified

Outcome Measures

Primary Outcomes (1)

  • genotype-phenotype correlation

    enrollment and sample analysis

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with ASDs and their parents and/or siblings

You may qualify if:

  • Diagnosis of autism spectrum disorder or suspected diagnosis based on clinical genetic test results (e.g., variant diagnosed via chromosomal microarray)
  • Age ≥ 18 months

You may not qualify if:

  • Presence of a metabolic disorder
  • Acquired developmental disability (e.g., birth asphyxia, trauma-related injury, meningitis, etc.) or cerebral palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderAsperger Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Christopher Walsh, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Genetics and Pediatrics, Harvard Medical School

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 1, 2009

Study Start

July 1, 2008

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2030

Last Updated

December 29, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Data is available through National Database for Autism Research (NDAR) and database of Genotypes and Phenotypes (dbGaP).

Locations

US(1)