Trial record 19 of 319 for:    Autism Spectrum Disorder

Phenotypic and Genetic Factors in Autism Spectrum Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00910559
First received: May 29, 2009
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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


Condition
Autism Spectrum Disorders

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Phenotypic and Genetic Factors in Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 1500
Study Start Date: July 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with ASDs and their parents and/or siblings

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910559

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joanna Reinwald, M.S.    617-355-9152    joanna.reinwald@childrens.harvard.edu   
Principal Investigator: Louis Kunkel, Ph.D.         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Louis Kunkel, PhD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Louis Kunkel Ph.D., Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00910559     History of Changes
Other Study ID Numbers: 04-05-075, 1R01MH085143-01
Study First Received: May 29, 2009
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Autism Spectrum Disorder
ASD
Autism
Asperger Syndrome
PDD-NOS
Pervasive Developmental Disorders- Not Otherwise Specified

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014