Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying

Status Completed

Clinical Trial Summary

There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed at the Cleveland Clinic using research equipment provided by IntegraGen. The second purpose is to identify genetic changes that may be associated with autism spectrum disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether genetic differences and changes may predict which individuals benefit from medicine used to treat attention problems or other psychiatric difficulties.

Between 600-800 people are expected to participate in this study - approximately 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.

Study procedures will vary based upon the specific group participants are suspected to fall into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental delay, healthy sibling, or unrelated healthy control).

- All individuals will be asked to participate in a cheek swab (gently swabbing the inside of your cheek) to obtain cells used for genetic testing. Genetic material will be stored with identifiers such as numbers, letters or codes.

- Parents or caregivers will be asked to complete questionnaires that examine medical and family history as well as current symptoms and quality of life for the participant.

- Participants may undergo speech and language testing. This involves answering questions, looking at pictures or identifying items.

- Information recorded in participant medical records will be reviewed and collected for this study.

Clinical Trial Description

n/a

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Attention Deficit Disorder with Hyperactivity
Attention Deficit/Hyperactivity Disorder
Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive
Developmental Delay
Disease
Hyperkinesis

Clinical Trial Details

NCT number	NCT01452061
Study type	Observational
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	N/A
Start date	January 2012
Completion date	December 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms