Does my child have to participate?
This study is totally voluntary and your decision will not affect the health care your child receives from his/her doctor. You always have the right to say "no" to a research study. If you do say "yes," you may take your child out of the study at any time. However, you should discuss this with the research team first so your child can be withdrawn in the safest way possible.
Why include children in research?
You may wonder why children are included in research at all. After all, research involves some uncertainty and some risks. Why not do research only on adults, who can decide for themselves if they want to participate? In fact, when possible, research is usually done first on adults. However, this also means that many medicines and treatments have only been carefully studied in adults and remain less studied in children. Children often don't respond to medicines the same way adults do, so research in children is very important.
Sometimes children need treatment for a condition where the most promising and doctor-recommended medications have mostly been studied in adults. Those medications can also be given during a study that carefully measures benefits and side effects. When medicines are given in the setting of a study, scientists and doctors can learn more about them. At the same time, children, their families, and personal physicians can benefit from the close supervision provided by the study, and information collected about an individual child's response to his/her medication can be used to guide future treatment decisions by families and physicians.
In addition to any personal benefit that may come from a study medication, or any benefit that comes from the careful monitoring involved in a research study, participation in research can also benefit others. Many children today are benefiting from research that was done on children in the past. For example, the current treatments for many childhood cancers and for cystic fibrosis are based on past research. Hopefully, the research done on children today will help children in the future in a similar way.
What will my child be asked to do?
We are interested in how these medications might affect weight gain, risk for diabetes, and problems with cholesterol. To measure these things we will ask your child to do two kinds of blood tests and two kinds of scanning tests. We'll do these tests before s/he starts medication, again about halfway through the study, and again when the study is over, about 12 weeks after the start of the medication. You will have between five and six study-related visits plus medication check-ups with the study doctor over the telephone or in person. You can be with your child during all of the testing.
All of these visits and tests are scheduled at the convenience of you and your child. We are able to work around school, work, sports, and other activity schedules as needed. If you need it, we can also arrange for a cab ride to and from your home for any part of the study.
Read on for information about the initial stages of the study.
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