Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to use MRI to learn about the similarities and differences between the brains of young children with Fragile X Syndrome (FXS) and young siblings of individuals diagnosed with autism spectrum disorder (ASD), called high-risk infant siblings. We will compare this information to that of typically developed children.
MRI is a way to take pictures of the body using a large magnet, radio waves and a computer. There is no radiation involved.
Autism spectrum disorder occurs in 1/4 of children in 2 high-risk groups: children with FXS and younger siblings of children with ASD. It is not clear whether the ASD seen in each of these groups stems from the same underlying cause. This study is one step towards a long-term goal of identifying early brain markers of altered development in efforts to develop better treatments and interventions.
Who can participate?
Infants and children, 3 months to 3 years old, who:
- Have an older, full biological sibling diagnosed with ASD
- Were born at 37 weeks or later
- Do not have a major medical condition, seizures or implanted device
What will happen in the study?
If your child qualifies and you decide you want to be in this research study, you and your child will come to Cincinnati Children’s for 1 to 3 visits over the next month.
The following is a list of some of the assessments, tests and procedures that will happen to your child during the study:
- Review of your child’s medical, psychiatric and developmental history (including past and present medication/supplement use)
- Review of family medical history
- Review of medical record results (previous behavioral, neuropsychological or other testing, genetic chromosomal or microarray testing, CBC, metabolic panels, lipid panels, and other blood testing, vital signs, medication history, imaging history, and all EEG reports/recordings)
- Height, weight and head circumference
- Developmental/cognitive testing
- Demographic questionnaire*
- Maternal pregnancy questionnaire and consent to release medical records of mother’s pregnancy care/course (optional)*
- Autism Diagnostic Observation Schedule (ADOS) at appropriate age*
- Aberrant Behavior Checklist (ABC)*
- Infant-toddler checklist*
*These assessments may be taken home, completed and mailed back to our research team or completed over the phone with a member of the study team.
During the MRI procedure, which should last about 60 minutes, you and your child will come to the Imaging Research Center at Cincinnati Children’s.
The MRI will not proceed until your child is asleep. Once your child is asleep, he or she will be swaddled in a blanket and then positioned in the scanner for imaging. Staff will place ear protection (like earmuffs) over your child’s ears.
The research staff will be able to see your child throughout the MRI exam. If your child wakes up and cries during the scan, we will stop the scan and try to get them to fall asleep or calm down before starting the scan again. If your child keeps crying, we will stop the research study.
A radiologist will look at the MRI images and will notify you should there be concerns.
Parents/guardians interested in having their child participate 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 neurological and neuropsychological examinations, and MRI 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?
The functional MRI, like a regular MRI, uses a large magnet and a computer to take detailed pictures of the brain. There is no radiation in an MRI scan. There are no known risks to a brain MRI in children.
Your child may have some discomfort due to the noise from the MRI scanner. We will use earplugs and earphones to decrease the noise that your child is exposed to.
Your child will have his or her medical record reviewed by study personnel. There is a risk of loss of confidentiality of your child’s medical record information. We will take steps to protect the privacy of your child’s medical information.
There may be other risks that we do not know about yet.
A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.