Clinical Trials / Research Studies
Study for Children 5 to 10 Years Old with Fragile X Syndrome (FXS) or Autism Spectrum Disorder (ASD)
Why are we doing this research?
Cincinnati Children’s is conducting a research study to see if listening to specific sounds (called auditory entrainment) can help improve learning and sensory symptoms in children with FXS. ASD controls are needed for comparison.
Who can participate?
Children/adolescents 5 to 10 years old who have a diagnosis of FXS or ASD may be eligible to participate.
Conditions
- Autism
- Disabilities: Developmental
- Disabilities: Intellectual
What will happen in the study?
This study includes 4 visits to Cincinnati Children’s, each lasting approximately 4 hours. Here are some of the things that will happen in this study:
Your child will have a/an:
- Medical and psychological assessment
- Developmental/cognitive testing, including an Autism assessment
- Neuropsychological testing via computer programs
- Auditory entrainment
- EEG (electroencephalography)- a test that measures brain activity
You, as the parent or guardian will:
- Answer questions about your child via questionnaires, checklists, and interviews
You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
Your child may not receive any direct benefit from participating in this research study.
However, as part of this research study, your child will receive medical, neurological and psychological examinations, and EEG brain scans at no charge to you or your insurance company. At your request, we will give you and your physician copies of your child’s test results for your records. You will be able to share these results with anyone you choose.
What are the bad things that can happen from this research?
There are minimal risks to this study, including mild discomfort with testing procedures and potential loss of confidentiality. We will discuss all possible risks or discomforts with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
Participants will receive $50 for each completed visit, up to $200 for time and effort.
Contact
Or Contact:
Jae Citarella
jae.citarella@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Ernest V. Pedapati, MD, MS, FAAP
Division of Psychiatry and Neurology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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