Why are we doing this research?
Cincinnati Children’s is conducting a research study to determine why and how teens, who will give a DNA sample (blood) for genetic testing, and their parent:
- Choose to learn the teen’s genetic test results for certain disease over others
- Feel about their genetic test choices
- Feel after learning the teen’s genetic test results
Who can participate?
Teens,13 to 17 years old, who are able to make independent decisions and their parent may be eligible to participate. Teens must be registered for MyChart or be willing to register.
What will happen in the study?
If you and your teen qualify, and you decide to participate, you will come to the Schubert Research Clinic at Cincinnati Children’s for 1 study visit lasting up to 2 hours.
Before you and your teen come to this visit, you will each be asked to complete an information form (contact information, age, race, gender, ethnicity, health status, etc.). We will also give you a link to a brief video that explains the type of genetic test we will be using in the research study.
The following is a list of what will happen during the study visit:
- A research team member will collect a blood sample from your teen for the genetic testing.
- Your teen will register for MyChart, if he or she is not already registered. MyChart gives you and your teen online access to parts of his or her medical records.
- You and your teen will each decide what type of results you want to learn about from the genetic testing and then each of you will be asked about the decision making process.
- Once you have decided which results to learn more about, you will each complete a brief survey.
- You and your teen will share and discuss your choices with one another. You will come to agreement on 1 set of choices on the panel that you both, together, want to learn about. A member of the research team will talk with you and your teen about the reasons for your choices (this information will be audio recorded and later de-identified).
- You and your teen will both sign and date a “joint” preference model about which results you selected (this will serve as the official record of your decisions).
- Once you and your teen have signed the “joint” preference model, you will both answer survey questions about the decision making process.
After the study visit is over, you will both have 2 weeks to change your decision. If you want to change your decision, you may scan and email or mail your request to the research team member listed below in the contact section. The request must have both your signature and your teen’s signature.
It may take up to 9 months before the testing results are ready to be shared. All results (negative or positive) will be placed in your teen’s electronic medical record at Cincinnati Children’s. We will also mail a copy of the report to your teen’s pediatrician.
You and your teen will be randomized (by chance, like flipping a coin) to learn any negative results (the test did not show any gene changes that can increase the risk for the types of diseases you and your teen selected) by either a scheduled phone appointment or through MyChart. You, your teen and the research team will not know which group you are in until you are told that results are available. At that time, you will be asked to view the results in MyChart or to make an appointment to learn the results by phone.
You and your teen can choose to learn any positive result (a change in a gene was found that can increase the risk for a disease that was included in your choices) by either phone or MyChart. The research team will ask you to view the results in MyChart or to make an appointment to learn the results by phone; however they will not know if the results are positive or negative.
About a week after learning the results, you and your teen will each be given a unique link to an online questionnaire. Answers to the questions will help us understand what you each think about the results and what you think about the way you learned the results. Then, 6 months later, you will both complete the online questionnaire a second time. Answers to these questions will help us understand if opinions change over time.
If completing an online questionnaire is difficult for you, we will mail you paper questionnaires. We will give you a pre-addressed, postage paid envelope to return the completed questionnaires back to us.
You and your teen’s participation in the study will last about 2 years. Researchers may spend an additional 2 years analyzing data and publishing the results.
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/your child’s participation may help others in the future who are given choices to learn genetic test results. You may have good feelings about learning your child’s negative results. Or, learning your child has a positive result may help you and your child’s doctor prevent the related disease or catch it early so it can be treated.
What are the bad things that can happen from this research?
This is a minimal risk study. Your teen may feel brief pain from the blood draw or have some bruising or swelling. You or your teen may find the time it takes to travel and participate inconvenient. You or your teen may also feel distress, anxiety or confusion about some test results. You can stop participating at any time.
A detailed list of possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study.
Will you/your child be paid to be in this research study?
Families may receive up to $80 for their time and effort during the 1-study visit lasting about 2 hours.