Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to create a way to collect and combine information about people with fragile X syndrome (FXS) into a database called FORWARD, the largest resource for clinical and demographic data on people with FXS in the United States.
Data collected annually in FORWARD will help researchers study how strengths and weaknesses in people with FXS change over time. It will also be used to help improve services and outcomes by developing better ways to evaluate and treat people with FXS.
Who can participate?
Children, teens and adults of all ages who have FXS may be able to participate.
What will happen in the study?
If you are interested in having your child participate in the FORWARD Registry and Database, your child will be scheduled for a standard FXS clinic visit at Cincinnati Children’s.
If your child is a new patient, Dr. Erickson and his staff will provide you with a consent form and a Registry intake form. If your child is already in FORWARD, then his or her yearly information forms will be filled out.
We will ask you to complete forms about your child’s care at the clinic, his or her education, treatments, and some other information.
These forms will be filled out by you on a yearly basis because information about your child might change. This will help us learn how problems associated with FXS change with age as well as help us find better ways of care. Your child’s doctor in the Fragile X Clinic will also get medical information about your child for the FORWARD Database on an annual basis.
Your child’s information will be stored indefinitely. However, you may contact the study staff and ask for your child to be removed from participating in FORWARD and from further follow-up at any time. You can also have any previous data removed.
Parents or guardians interested in learning more about this study will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, 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.
Extended FORWARD Participation:
Once in the FORWARD Database, you have the option to participate in the extended portion. This consists of an annual comprehensive neuropsychological evaluation that looks a lot like a school evaluation. The evaluation will feel like we are solving puzzles and playing games and may take up to 4 hours. We will be looking at things like memory, language, and social skills. We will provide parents with the results of testing to be used for whatever purposes they please.
What are the good things that can happen from this research?
Your child may not receive any direct medical benefit from participating in this study; however, the information learned from this research study may benefit other people with FXS in the future.
You may also receive results of testing free of charge upon completion of the extended participation in FORWARD.
What are the bad things that can happen from this research?
There is a small risk of the loss of confidentiality as well as boredom or nervousness when answering questions.
A detailed list of possible risks will be provided to those participants, parents or guardians interested in knowing more about this study.