Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

The purpose of the study is to test the efficacy of a telehealth behavioral treatment (TBT)
protocol to improve medication adherence in children and adolescents with IBD via a
randomized controlled clinical trial. Participants in the TBT condition will be compared to
those in an education only (EO) condition. In order to examine clinical significance of the
intervention, treatment outcomes will include disease severity, HRQOL, and health care
utilization. This randomized controlled clinical trial for nonadherence to medication
randomizes participants to either the TBT or EO intervention condition, with assessments
occurring at baseline, post-treatment, and 3-, 6-, and 12-month follow-up. Both conditions
will participate in a self-guided educational intervention during week 6 of enrollment, with
three intervention sessions at weeks 8, 10, and 12. A 4-week run-in phase immediately
preceding randomization is utilized to establish participants' baseline adherence.
Assessments will occur at week 5 (Baseline Assessment 1), week 14 (Post-treatment Assessment
2), and 3-, 6-, and 12-month post-treatment follow-up (Assessments 3, 4, and 5).
Intervention topics will differ for each condition; however, the frequency of contact is
equivalent across conditions.

Inclusion Criteria:

- Patient is currently seen for care at one of the collaborating research sites:
Cincinnati Children's Hospital Medical Center, Connecticut Children's Medical Center,
Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of
California San Francisco Benioff Children's Hospital, or Children's Mercy Hospitals
and Clinics

- Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis

- Patient age between 11-18 years

- Patient currently living at home

- Patient currently prescribed at least one daily oral immunomodulator (e.g.,
6-MP/azathioprine) and/or 5-ASA (e.g., mesalamine)in pill form

- English fluency for patient and parents

- Inclusion for Randomization: <90% adherence to immunomodulator and/or 5-ASA during
four week run-in phase

Exclusion Criteria:

- Diagnosis of pervasive developmental disorder in patient or parent

- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent