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NCT00910559 Clinical Trial

Phenotypic and Genetic Factors in Autism Spectrum Disorders

Autism Spectrum Disorders Clinical Trial

Official title:
Phenotypic and Genetic Factors in Autism Spectrum Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00910559
Other study ID # 04-05-075
Secondary ID R01MH085143R01MH
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2008
Est. completion date February 2027

Study information
Verified date February 2024
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Participation in this research study involves two research visits, at least one of which is at Children's Hospital Boston. The first visit lasts about 4-6 hours. On this visit, the child will work with a research assistant on a few different cognitive assessments while one or both parents answer interview questionnaires about the child's development, along with other family history information. The second visit at the hospital lasts about 2 and a half hours and involves medical history and family history questionnaires, as well as height, weight, and head circumference measurements and a blood draw from each family member. In addition, digital photographs will be taken of each family member and a 3-D picture of the child's face will be taken. Shortly after the visits, participants will receive a research report of our observations. These results include cognitive, behavioral, developmental, and social findings. The total time commitment for the study is 6 to 8 hours.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1500
Est. completion date February 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 18 Months and older
Eligibility Inclusion Criteria: - Diagnosis of autism spectrum disorder or suspected diagnosis based on clinical genetic test results (e.g., variant diagnosed via chromosomal microarray) - Age = 18 months Exclusion Criteria: - Presence of a metabolic disorder - Acquired developmental disability (e.g., birth asphyxia, trauma-related injury, meningitis, etc.) or cerebral palsy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Boston Children's Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary genotype-phenotype correlation enrollment and sample analysis
See also
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