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Phenotypic and Genetic Factors in Autism Spectrum Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910559
First Posted: June 1, 2009
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Louis Kunkel, Boston Children's Hospital
May 29, 2009
June 1, 2009
June 5, 2017
July 2008
February 2018   (Final data collection date for primary outcome measure)
genotype-phenotype correlation [ Time Frame: enrollment and sample analysis ]
Not Provided
Complete list of historical versions of study NCT00910559 on ClinicalTrials.gov Archive Site
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Phenotypic and Genetic Factors in Autism Spectrum Disorders
Phenotypic and Genetic Factors in Autism Spectrum Disorders
The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.
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.
Observational
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Whole blood
Non-Probability Sample
Individuals with ASDs and their parents and/or siblings
Autism Spectrum Disorders
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
February 2020
February 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00910559
04-05-075
R01MH085143 ( U.S. NIH Grant/Contract )
R01MH083565 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Data is available through National Database for Autism Research (NDAR) and database of Genotypes and Phenotypes (dbGaP).
Louis Kunkel, Boston Children's Hospital
Boston Children’s Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Louis Kunkel, PhD Boston Children’s Hospital
Boston Children’s Hospital
June 2017