A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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This project will test if a phone intervention can improve the medicine-taking behavior of teens with IBD. The investigators will study teens who are taking medicine by mouth. The investigators will test if two phone calls that help teens solve problems with their IBD medicine help to increase how often teens take their medicine. The study will also see if there is any extra benefit of more sessions (four compared to two). The investigators will ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and speak English. They must also take an IBD medication by mouth and have a parent who also wants to be in the study. Teens who agree to be in the study will fill out forms at the beginning (participant week 0), middle (participant week 12), and end of the study (participant week 20). After assessment 1, they will be randomly assigned to either receive 2 phone calls or a wait list group (participant weeks 6-10). After that, they will complete a second assessment. After the second assessment, teens who got the 2 phone calls right will be re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who were in the wait list group will get two phone sessions (participant weeks 14-18). After that, there will be a final assessment (participant week 20). The investigators expect the phone intervention sessions to reduce barriers to medicine taking, improve medicine taking, and improve teen quality of life.

Official Title
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A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Behavioral: 2 Family-based problem solving phone sessions
* Behavioral: 4 Family-based problem solving phone intervention sessions
* Behavioral: Wait list comparison group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient age 11-18 years patient English speaking patient legal guardian willing to participate patient on oral IBD maintenance medication for 3 months or longer Exclusion Criteria: history of significant parent-reported cognitive or developmental delay

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wait List<br> | Behavioral: Wait list comparison group<br>* Wait list comparison group to receive intervention at later point.<br>|
| Experimental: 2 phone sessions<br> | Behavioral: 2 Family-based problem solving phone sessions<br>* 2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.<br>|
| Experimental: 4 phone sessions<br> | Behavioral: 4 Family-based problem solving phone intervention sessions<br>* 4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | participants will use MEMS bottles to capture adherence data from participant week 0 - participant week 20. Additionally, adherence interviews and pill counts will be conducted at participant week 0, 12, and 20. | beginning at baseline - week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | at baseline, week 12, and week 20 | 
| Adherence barriers |  | at baseline, week 12, and week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, adolescent