A Research Study to Examine the Diets of Autistic Children
What is the purpose of this study?
The purpose of the study is to investigate whether certain dietary nutrients are abnormal in children with autism spectrum disorders.
Who will be included in this study?
- Children between the ages of 3 to 18 years old with or without a healthy sibling also willing to participate in this study.
- Healthy children who are typically developing and who do not have a sibling with an autism spectrum disorder will also be included in the study.
What is involved?
If your child has autism, the study involves two visits.
- Visit 1: Parents will be interviewed about the child's development and symptoms of autism.
- Visit 2: Parents will be asked questions about their child's diet. Your child will have his or her blood drawn.
If your child is developing typically, the study involves one visit.
- Parents will be interviewed about their child's development and will be asked questions about their child's diet. Your child will have his or her blood drawn.
What are the benefits?
Your child will receive a developmental screening at no charge. You will receive feedback on the developmental evaluation as well as information about levels of certain nutrients in your child's blood.
Your child may receive no direct benefit from participating in this study. The biggest benefit is that your child may be helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
Subjects will undergo one blood draw. Blood sampling may cause stress, some pain, and/or bruising on the arm at the site where the blood is taken.
What is the compensation?
Participants will receive $25 for time and travel expenses after each study visit.
Who should I contact for more information?
Twila Strasinger
Cincinnati Children's Hospital Medical Center
Clinical Trials Office, MLC 7004
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: (513) 636-0599
twila.strasinger@cchmc.org
