Peer Mentoring to Improve Self-management in Youth With IBD

Summary

This study is a multi-site randomized controlled clinical trial evaluating the efficacy of a peer mentoring program for improving the self-management of youth with IBD. The primary outcomes are youth QOL and functioning in typical life activities. Secondary outcomes are disease outcomes, including disease severity and clinical outcomes (hospital admissions, clinic appointments, missed appointments, procedures). Mentor and parent QOL will also be assessed as secondary outcomes. Mechanisms that may contribute to the effects of the Mentoring Program will be investigated: Parent and child self-efficacy, illness uncertainty, coping, social support and child perceived stigma. Sex will be explored as a moderator.

A total of 200 youth and their parents and 100 mentors will be enrolled. Eligibility criteria for youth include age 10-17 years, parent and child English fluency, and no documented neurodevelopmental disorder or history of hospitalization for a psychiatric or behavioral disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing their IBD well. They will be rigorously screened via online application, interview, checks of references, driving records, and social media, background check, and successful completion of a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an "Educational Activity" comparison group, with baseline assessments occurring prior to randomization. Follow-up assessments will occur post-intervention and 6 months later.

The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month.

Group activities target self-management skills through experiential opportunities, modeling, and direct instruction. Educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event.

The Educational Activity comparison group consists of separate educational group events on the same topics (with no social time), educational information posted online, and monthly encouragement to engage in activities in the community.

Conditions

• Pediatric Crohns Disease
• Pediatric Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

BEHAVIORAL

Group educational activities

Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.

BEHAVIORAL

IBD educational website

Website with age-appropriate educational information, including information from the group educational activities.

BEHAVIORAL

Monthly check-in calls from program coordinator

Phone calls from coordinator to encourage youth to do something fun with a friend (comparison group) or mentor (Mentoring Program). During the COVID-19 pandemic, virtual activities are encouraged. For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.

BEHAVIORAL

Mentor

Mentees will be matched with a mentor for a year-long, 1:1 mentee-mentor relationship. Matching mentors and mentees is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month, one of which can be attending a group activity together. Due to the COVID-19 pandemic, a modification was approved so that all study activities can be conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via Skype, and group activities are live streamed

BEHAVIORAL

Fun group activities

Program participants vote on "fun" group activities to participate in for support and to learn self-management skills through experiential opportunities and modeling. These are live streamed during the COVID-19 pandemic.

BEHAVIORAL

Parent support group

Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing during group events (virtually during the COVID-19 pandemic).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Kelly Boone

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-12

Primary Completion

2024-03-01

Completion

2024-03-01

Countries

• United States

Study Locations