Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder
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Purpose
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.
| Condition |
|---|
|
Autism Spectrum Disorder Attention Deficit/Hyperactivity Disorder Developmental Delay |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Understanding Genetic Differences Associated With Autism Spectrum and Attention Deficit/Hyperactivity Disorder |
- Autism Spectrum Disorder clinical diagnosis [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Genetic material via a cheek swab will be collected.
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
ASD
Participants with autism spectrum disorder.
|
|
ADHD/DD
Participants with attention deficit/hyperactivity disorder, developmental delay or psychiatric disorder.
|
|
Siblings
Siblings without a developmental or psychiatric disorder.
|
|
Control
Unrelated individuals without a developmental or psychiatric disorder.
|
Eligibility| Ages Eligible for Study: | 1 Year to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
About 600 people will take part in this study - 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.
Inclusion Criteria:
- Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, or Asperger's Disorder or have a clinical diagnosis of another developmental or psychiatric disorder (developmental/psychiatric controls), or have no specific developmental or psychiatric diagnosis (healthy controls).
- Age 1 to 12.
Exclusion Criteria:
- For individuals with ASD and developmental concern controls, presence of a known or strongly suspected genetic disorder based on all available clinical data.
- Age less than 1 or greater than 12.
- Individuals for whom DNA is not available for analysis.
- Individuals for whom it is anticipated that they will not be available for follow-up at the Cleveland Clinic during the study period.
- Any medical diagnoses that might preclude participation in a low risk, non-interventional research study and any participant who at the discretion of the clinical investigator is not medically able to participate in the study (e.g., unable to comply with cheek swab or other procedure or has serious medical condition which precludes participation).
Contacts and Locations| Contact: Allison Voorman | 216.448.6421 | voormaa@ccf.org |
| Contact: Becky Embacher, M.Ed. | 216.448.6493 | embachr@ccf.org |
| United States, Ohio | |
| Cleveland Clinic Center for Autism | Recruiting |
| Cleveland, Ohio, United States, 44104 | |
| Contact: Allison Voorman 216-448-6421 voormaa@ccf.org | |
| Contact: Becky Embacher, M.Ed. 216.448.6493 embachr@ccf.org | |
| Principal Investigator: Thomas W Frazier, Ph.D. | |
| Principal Investigator: Charis Eng, M.D., Ph.D. | |
| Sub-Investigator: Rocio Moran, M.D. | |
| Sub-Investigator: Sumit Parikh, M.D. | |
| Sub-Investigator: Leslie Speer, Ph.D., NCSP | |
| Sub-Investigator: Michael Manos, Ph.D. | |
| Sub-Investigator: Elaine Schulte, M.D., MPH | |
| Principal Investigator: | Thomas W Frazier, Ph.D. | The Cleveland Clinic |
| Principal Investigator: | Charis Eng, M.D., Ph.D. | The Cleveland Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas W. Frazier, Ph.D, Center for Autism Research Director, Cleveland Clinic Foundation |
| ClinicalTrials.gov Identifier: | NCT01452061 History of Changes |
| Other Study ID Numbers: | CCF 11-949 |
| Study First Received: | October 11, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Cleveland Clinic:
|
Autism Spectrum Disorder Attention Deficit/Hyperactivity Disorder Developmental Delay |
Additional relevant MeSH terms:
|
Autistic Disorder Attention Deficit Disorder with Hyperactivity Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Attention Deficit and Disruptive Behavior Disorders |
Nervous System Diseases Hyperkinesis Dyskinesias Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013