Chronic Headache (migraine) Study for Children
What is the purpose of this study?
The purpose of this research is to test whether behavioral/education therapy combined with medicine can help adolescents who suffer from chronic headaches.
Who will be included in this study?
Adolescents between the ages of 10 and 17 who experience more than 15 headache days per month may be eligible to participate in this study.
What is involved?
This study lasts for 18 months and includes 18 visits. The following is a list of procedures and activities that will take place during the study:
- One-hour therapy sessions that occur weekly for eight weeks
- Three monthly booster sessions after the eight-week treatment
- Four follow-up meetings every three months following booster sessions
- Standard medical visits occur every four weeks with therapy sessions
- Participants will keep a daily headache diary and complete small homework assignments
- An EKG, a urine pregnancy test, and a psychological interview are part of the screening process.
What are the benefits?
By participating in this study, your child will receive medication and therapy at no charge. This therapy is designed to give you more information about headache, decrease your pain, and improve your child's ability to deal with pain while participating in day-to-day activities. Unlike your child's clinic visits, these sessions are arranged to fit you and your child's schedules. You will never have to wait for an appointment. Your child's overall health will be carefully monitored by nurse practitioners during routine safety visits, which are not billed to your insurance. The biggest benefit from participating in this study is that you and your child may be contributing to research that helps others. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, 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. Study procedures will not begin until the parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
The psychological interview and questionnaires may present some minor discomfort when answering some of the questions or by providing sensitive information. The study medication has minor side effects that include dry mouth, abdominal pain, bitter taste, sleepiness, dizziness, heart beat changes, or lowered blood pressure. There are no known risks related to the behavioral/education treatment.
What is the pay?
All participants receive therapy and medication at no charge. Participants will also be compensated for their study time and travel with cash and gift certificates.
Who should I contact for more information?
Maxx Somers
Cincinnati Children's Hospital Medical Center
Department of Behavioral Medicine and Clinical Psychology, MLC 3015
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone 513-656-1840
Email maxx.somers@cchmc.org
