Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

This study includes 5 to 8 study visits to Cincinnati Children’s over 6 months. There are 3 phases in the study. Here are some of the things that will happen in this study.

During the first screening phase of 4 weeks, your child will:

• Be asked to keep a daily headache diary
• Complete questionnaires
• Have an ECG (an electrocardiogram — abbreviated as EKG or ECG — is a test that uses a machine to measure the electrical activity of the heartbeat) and an MRI
• Undergo sensory testing using pressure and temperature stimuli

In the second phase or intervention phase of 12 weeks, your child will:

• Receive 1 of the 5 interventions by chance (like flipping a coin) which include Behavioral Treatment A, B or C, a placebo pill, or the study medication amitriptyline for 8 weeks followed by a safety phone call 4 weeks later
• Be asked to keep a daily headache diary
• After about 8 weeks of receiving his/her intervention, be asked to come back in to repeat the questionnaires, MRI, and sensory testing

In the third phase or follow-up phase, you will be contacted about 3 months after the final study visit, and you and your child will be asked to complete an online set of questionnaires about your child’s headaches, medicine use, healthy habits, illnesses, quality of life, pain and sleep.

You and your child will be given a consent form that thoroughly explains all of the details of the study including the specifics of the behavioral interventions. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.