Who can participate?
Children, 2 to 12 years old, who:
- Have been diagnosed with epilepsy within the past 7 to 8 months
- Are being prescribed antiepileptic medication
- Live within 75 miles of the Cincinnati Children’s Burnet Campus
A parent or primary caregiver will also participate in this study.
What will happen in the study?
If you and your child are eligible, and you decide to participate, you will be in this study for about 23 months (almost 2 years).
During the study, you will receive a pill bottle with a special cap, called a MEMs cap. The MEMS cap is an electronic monitor that records the time and date that the bottle was opened. You will be asked to use the MEMs cap for the entire study and bring it to each visit.
You will need to place all of your child’s pill-based antiepileptic medication in the MEMs bottle. If your child has liquid medication, you will open the empty MEMs cap at the same time you give your child’s liquid medication.
After a 30-day monitoring period, we will meet you at a place convenient to you to download the information from the MEMS cap. Based on this information, you and your child will be placed in 1 of 3 groups: Maintenance Group, Treatment Group A or Treatment Group B.
Participants who do not demonstrate difficulties with adherence will be placed in the Maintenance Group. If you and your child are placed in the Maintenance Group, you will be in the study for a total of 6 months and complete several questionnaires at study visits.
During the 6-month period, you and your child will have 2 opportunities to move into Treatment Group A or B if adherence drops. However, if after this 6-month period you and your child do not demonstrate difficulties with adherence, enrollment in the study will end.
Treatment Group A or B
Participants who have some difficulties with adherence will be randomized (by chance, like flipping a coin) into 1 of the 2 Treatment Groups (A or B). Based on when you and your child are randomized, participation will last about 17 months to 2 years.
While in Treatment Group A or B, you and your child will have 8 treatment sessions over 4 months. Six of the treatment intervention sessions will be in-person, lasting about 1 hour, and take place with a trained interventionist in the Division of Behavioral Medicine and Clinical Psychology at Cincinnati Children’s. The other 2 sessions will be by phone and last 15 to 20 minutes each.
At the end of some of the intervention session, you and your child will complete several questionnaires.
Finally, you and your child will have 3 follow-up visits at Cincinnati Children’s over a period of 12 months, following the intervention sessions.
You will be asked to bring your MEMS Cap to all study and intervention visits.
Parents 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 or may not receive a direct benefit from participating in this research study. We hope that your child’s participation will help him or her feel better or help to improve his or her adherence to anti-epileptic medication, but we don’t know if it will. You and your child may also benefit from learning more about epilepsy and safety, as well as improve problem-solving and disease management skills.
When we finish this research, we expect to know more about how to improve anti-epileptic mediation adherence and disease management in the future, which may help other children with epilepsy later on.
What are the bad things that can happen from this research?
There is a risk that the treatment being tested in this study will not work. Attending the intervention sessions may also inconvenience you; however, every effort will be made to schedule these at times convenient for you and your family.
A detailed list of possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study.