Genetics, Brain Structure and Thinking Skills in Autism

The purpose of this research is to better understand the genetic, biochemical, cognitive and behavioral symptom abnormalities that contribute to autism spectrum disorders. The investigators anticipate recruiting at least 100 participants with autism spectrum disorder and large head size, at least 100 participants with autism spectrum disorder without large head size and at least 40 healthy siblings. Biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes. Participants are asked to complete cognitive testing, a blood draw, urine collection and measurement of his/her height, weight and head circumference. Parents or caregivers may be asked to complete a diagnostic evaluation and will complete questionnaires that examine the participant's medical and family history as well as his/her current symptoms, functioning, and quality of life. A brief report simply listing and giving a basic description of any behavioral diagnostic information, autism symptoms, adaptive functioning, and a listing of results from cognitive testing will be provided as part of this study.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Malformations of Cortical Development Malformations of Cortical Development, Group I Megalencephaly Mental Disorders Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations Neurodevelopmental Disorders

Age range

2 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Center for Autism

Cleveland, Ohio, 44104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of autism
Consent from parents or guardians or an adult with or suspected of having an autism spectrum disorder that does not require a legal guardian or an adult who is the healthy sibling of an individual with an autism spectrum disorder.
Youth ages 2-17 and adults ages 18-50. Youths and adults who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent.
Families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish.
Youth ages 2-17 and adults ages 18-50 who do not have an autism spectrum disorder or are not suspected of having an autism spectrum disorder and who have a sibling with an autism spectrum disorder who has participated in the present study.

Exclusion criteria

Clinically significant medical disease that would prohibit participation in the study procedures.
Children younger than 2 years old and adults older than 50 years old.

Treatment and study plan

Primary outcomes

Total Brain Volume

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

National Center for Research Resources (NCRR)
National Institutes of Health (NIH)

Registry information

Official study title

Genetic, Biochemical, Behavioral and Neuroimaging Phenotypes of Autism Spectrum Disorders (ASDs)

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Oct 14, 2011
Registry last updated: Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed