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

NCT ID: NCT01237847

Last Updated: 2010-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Keywords

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inflammatory bowel disease IBD Crohn's disease ulcerative colitis adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Wait List

Group Type OTHER

Wait list comparison group

Intervention Type BEHAVIORAL

Wait list comparison group to receive intervention at later point.

2 phone sessions

Group Type EXPERIMENTAL

2 Family-based problem solving phone sessions

Intervention Type BEHAVIORAL

2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

4 phone sessions

Group Type EXPERIMENTAL

4 Family-based problem solving phone intervention sessions

Intervention Type BEHAVIORAL

4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

Interventions

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2 Family-based problem solving phone sessions

2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

Intervention Type BEHAVIORAL

4 Family-based problem solving phone intervention sessions

4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

Intervention Type BEHAVIORAL

Wait list comparison group

Wait list comparison group to receive intervention at later point.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Rosalind Franklin University of Medicine and Science

OTHER

Sponsor Role lead

Responsible Party

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Rosalind Franklin University of Medicine and Science

Principal Investigators

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Rachel Neff Greenley, PhD

Role: PRINCIPAL_INVESTIGATOR

Rosalind Franklin University of Medicine and Science

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

Greenley RN, Gumidyala AP, Nguyen E, Plevinsky JM, Poulopoulos N, Thomason MM, Walter JG, Wojtowicz AA, Blank E, Gokhale R, Kirschner BS, Miranda A, Noe JD, Stephens MC, Werlin S, Kahn SA. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial. Inflamm Bowel Dis. 2015 Nov;21(11):2649-57. doi: 10.1097/MIB.0000000000000530.

Reference Type DERIVED
PMID: 26218142 (View on PubMed)

Other Identifiers

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CCFA#2838

Identifier Type: -

Identifier Source: org_study_id