Crohn's Disease and Colitis

IBD Research Study for Teens and their Families

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting a family-based research study (sometimes referred to as a clinical trial or clinical study), to look at how well intervention works in improving treatment adherence (follow-through with treatment recommendations like taking medications) in teenagers with Crohn’s Disease and ulcerative colitits or inflammatory bowel disease (IBD).

Who will be included in this study?

Families with a teenager between the ages of 11 and 17 years old who has been diagnosed with Crohn’s Disease or ulcerative colitis and is currently receiving treatment for IBD may be eligible to participate. (The family may include one parent, two parents or a guardian.)

What is involved?

The study will last for approximately 13 months and includes 5 to 9 study visits. You and your child will be randomized (put into one of two groups by chance) into either the “Usual Care Group” or the “Intervention Group.” The following is a list of some of the procedures that will take place during the study:

The usual care study group involves 5 visits, about 60-90 minutes each. Study visits will occur at week 0 (baseline), week 6, and 3 months, 6 months, and 12 months later (5 total). You and your child will be asked to fill out questionnaires and use an electronic pill container, called a MEMS Cap, to store and retrieve your child’s medication. Your child’s medical record will be reviewed; information about other procedures will be provided to those interested in knowing more about this study.
The intervention study group involves 9 visits, about 60-90 minutes each. Study visits will occur at week 0 (baseline), weeks 2, 3, 4, 5, and 6, and 3 months, 6 months, and 12 months later (9 total). You and your child will be asked to fill out questionnaires and use an electronic pill container, called a MEMS Cap, to store and retrieve your child’s medication. You and your child will also take part in 4 treatment sessions which will occur in group format. Your child’s medical record will be reviewed; information about other procedures will be provided to those interested in knowing more about this study.

What are the benefits?

If you and your child agree to take part in this research study, your child might benefit by improved adherence to his/her IBD medication. You and your child might also benefit by improved communication about managing IBD treatments and improved disease management skills. In addition, the information that researcher’s acquire from this study will allow health care providers and other parents and patients to have a better understanding of how to improve IBD adherence and treatment management.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, 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 a parent or guardian and the child have reviewed and signed this form.

What are the risks and discomforts of the study?

You or your child may feel uncomfortable answering some of the questions on the questionnaires and/or in the interviews and can refuse to answer for any reason. You might be slightly inconvenienced by attending treatment sessions at Cincinnati Children’s Hospital Medical Center; however, every effort will be made to schedule these at convenient times for you and your family. A detailed list of risks and discomforts will be provided to those interested in knowing more about this study.