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SEED FAQ - Frequently Asked Questions
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Questions
The Study to Explore Early Development, or SEED, is a five-year, multi-site collaborative study that will help identify what might put children at risk for autism spectrum disorders (ASD’s) and other developmental disabilities. It is being conducted by the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network, which includes six study sites and a data coordinating center.
What are the sites that are participating?
The six CADDRE centers are:
- California CADDRE: Kaiser Permanente Division of Research and the California Department of Health Services
- Colorado CADDRE: Colorado Department of Public Health and Environment and the University of Colorado at Denver and Health Sciences Center
- Georgia CADDRE: the National Center on Birth Defects and Developmental Disabilities
- Maryland CADDRE: Johns Hopkins University and Kennedy Krieger Institute
- North Carolina CADDRE: University of North Carolina at Chapel Hill
- Pennsylvania CADDRE: University of Pennsylvania School of Nursing and The Children’s Hospital of Pennsylvania
The CADDRE Data Coordinating Center is operated by Michigan State University. The CADDRE Laboratory is operated by Johns Hopkins University.
In order to participate in North Carolina SEED, children who are invited must:
- Be born between September 1, 2003 and August 31, 2005.
- Be born and still living in the 10-county study area — Alamance, Chatham, Davidson, Durham, Forsyth, Guilford, Johnston, Orange, Randolph, and Wake counties of North Carolina.
- Have a legal guardian.
- Have a primary caregiver who has cared for them since they were at least 6 months old.
- Have a primary caregiver who speaks English.
Why is the study only looking at children between the ages of 2-5?
The study will focus on children who are 2 to 5 years old. This age range was selected to reduce the amount of time since pregnancy and early development so that parents can remember the events during these time periods is better, so medical information is easier to retrieve, so families are less likely to have moved away from the study area, and so it will also be near the beginning of treatment for children in developmental intervention programs.
I know someone who would be interested in signing up for this study. How can I refer them?
If you know someone who meets the study eligibility criteria and is interested in learning more about the study, you may have them call the SEED Helpline toll free at 1-866-633-8003. Those interested families who refer themselves for participation must have an eligible child who already has a diagnosed ASD.
My child doesn't have autism. Why does the study want my family to participate?
It is important that we speak with a wide range of families in order to gain an accurate understanding of child development. For that reason, we will be asking all kinds of families to participate.
What are the other developmental disabilities being studied?
We will be studying a range of other developmental disabilities, including mental retardation, developmental delay, and other behavioral problems in early childhood.
Does this study involve treatment, intervention, or medication of some kind?
No, the study does not include any type of medical treatment, intervention, or medication. We will be studying the characteristics of children and families in order to learn more about what causes autism and other developmental delays. This may lead to better services and treatments for children with developmental disabilities in the future.
Does my child have to have blood drawn? Do I have to do all of the study activities?
You can refuse any study activity and still participate in other study activities. However, it is important for the research that we get a complete picture of every family so we encourage families to complete all study activities.
Where is the developmental assessment done?
Will families get any results from the study tests?
We will send each family who participates in the study a letter that explains the results of the developmental exams performed during their study visits.
One of my child's biological parents is unavailable. Can my child still participate?
We encourage both of the child’s biological parents to participate in the study in order to get the most accurate understanding of the family for our research. However, if one of the child’s biological parents is unavailable, the family can still participate in the study.
Study results will be released to the public as soon as they become available. Because the study involves so many families, we will be collecting study data from 2007 through 2010. After that, the data will need to be analyzed. Once data analysis has been completed, results will be reported. Some analyses may be conducted before the study data collection is over and those results can be released earlier. Families who participate in SEED will receive a study newsletter that will include some of these early results.
How do I know my family's information is protected?
The CDC has received a Certificate of Confidentiality. A Certificate of Confidentiality guarantees that any information that is collected that could identify you or your child will be used only for this project. It cannot be given to anyone else unless you give your written consent or unless otherwise required by law.
What is the study's OMB number?
This study is approved by the US Office of Management and Budget. The OMB number is 0920-0741.
Who can I contact if I have questions about my rights as a research subject?
If you are a participant in a study at the University of North Carolina at Chapel Hill and have questions or concerns about your rights as a research subject you may contact, anonymously if you wish, the Office of Human Research Ethics by calling (919) 966-3113 or by email using
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. Routine questions about scheduling, explanation of procedures, or similar matters about SEED should be addressed to the SEED Helpline toll free at 1-866-633-8003 or
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.
Will the study include vaccines as a potential cause of autism?
Yes, the study will include looking at vaccines. The mercury exposures being studied include – vaccines that the mom received during pregnancy, the child’s vaccine exposures after birth and specific other factors such as RhoGAM treatment in pregnancy.
I have questions about my child's development. Who can I contact?
Your child's physician is the best person to discuss your child's development with you.
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