Peer Mentoring to Improve Self-management in Youth With IBD

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Pediatric Ulcerative Colitis; Pediatric Crohns Disease
• Intervention / Treatment: Behavioral: Group educational activities; Behavioral: IBD educational website; Behavioral: Monthly check-in calls from program coordinator; Behavioral: Mentor; Behavioral: Fun group activities; Behavioral: Parent support group

Detailed Description

The proposed 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, which can remain significantly impaired even when the disease is in remission, but have received little empirical attention. 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 may mediate relationships between mentoring and outcomes. Sex will be explored as a moderator.

A total of 200 youth and their parents and 100 mentors will be enrolled in the study. 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. Youth in the Educational Activity group will be yoked to those in Mentoring Program, and the timing of their follow-up assessments will correspond to their yoked peer.

The Mentoring Program was developed via focus groups, an NIH-funded pilot study, national mentoring resources, and the PI's 10 years of experience with Big Brothers Big Sisters. It consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. 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), as well as participate in an activity (in person or virtually) 1 - 2 times per month, one of which can be attending a group activity together. The investigators expect the relationship to last 1 year, which is associated with better outcomes than shorter relationships.

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 (e.g., dietitian, pediatric gastroenterologists). They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents in the Mentoring Program participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics.

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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Mackner, PhD; Phone Number: 614-722-4716; Email: Laura.Mackner@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Abigail Wexner Research Institute at Nationwide Children's Hospital
      • Contact: Laura Mackner, PhD; Phone Number: 614-722-4716; Email: Laura.Mackner@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Mentees:

• Diagnosis of IBD
• Age 10 - 17 years
• Parent and child English fluency
• No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder

Mentors:

• ≥16 years
• ≥1 year post-diagnosis of IBD
• Managing their IBD well
• Pass a screening that includes an online application, interview, 3 character references, checks of driving records and social media, background check, mentor training

Exclusion Criteria:

Mentees: No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mentoring program; 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 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. Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics. Due to the COVID-19 pandemic, these activities can be conducted virtually.	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).
Active Comparator: Educational activity program; 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. Due to the COVID-19 pandemic, participants are encouraged to interact socially in safe ways, e.g., outdoors or virtually.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 month youth quality of life: PedsQL	PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	12 months post mentor-mentee introduction
18 month youth quality of life: PedsQL	PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	18 months post mentor-mentee introduction
12 month change from baseline Youth quality of life: PedsQL	PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	Baseline to 12 months post mentor-mentee introduction
18 month change from baseline Youth quality of life: PedsQL	PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	Baseline to 18 months post mentor-mentee introduction
12 month youth functional disability	Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.	12 months post mentor-mentee introduction
18 month youth functional disability	Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.	18 months post mentor-mentee introduction
12 month change from baseline youth functional disability	Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.	Baseline to 12 months post mentor-mentee introduction
18 month change from baseline youth functional disability	Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.	Baseline to 18 months post mentor-mentee introduction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 month Youth disease outcomes - Crohn's Disease severity	Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.	12 months post mentor-mentee introduction
12 month Youth disease outcomes - Ulcerative Colitis severity	Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.	12 months post mentor-mentee introduction
18 month Youth disease outcomes - Crohn's Disease severity	Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.	18 months post mentor-mentee introduction
18 month Youth disease outcomes - Ulcerative Colitis severity	Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.	18 months post mentor-mentee introduction
12 month number of hospital admissions in previous 6 months	12 month number of hospital admissions in previous 6 months	12 months post mentor-mentee introduction
18 month number of hospital admissions in previous 6 months	18 month number of hospital admissions in previous 6 months	18 months post mentor-mentee introduction
12 month number of clinic appointments in previous 6 months	12 month number of clinic appointments in previous 6 months	12 months post mentor-mentee introduction
18 month number of clinic appointments in previous 6 months	18 month number of clinic appointments in previous 6 months	18 months post mentor-mentee introduction
12 month number of missed appointments in previous 6 months	12 month number of missed appointments in previous 6 months	12 months post mentor-mentee introduction
18 month number of missed appointments in previous 6 months	18 month number of missed appointments in previous 6 months	18 months post mentor-mentee introduction
12 month number of procedures in previous 6 months	12 month number of procedures appointments in previous 6 months	12 months post mentor-mentee introduction
18 month number of procedures in previous 6 months	18 month number of procedures appointments in previous 6 months	18 months post mentor-mentee introduction
12 months Mentor QOL	PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	12 months post mentor-mentee introduction
18 months Mentor QOL	PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	18 months post mentor-mentee introduction
12 month change from baseline Mentor QOL	PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	Baseline to 12 months post mentor-mentee introduction
12 month Parent QOL	PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	12 months post mentor-mentee introduction
12 month change from baseline Parent QOL	PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.	Baseline to 12 months post mentor-mentee introduction

Collaborators and Investigators

• Sponsor: Laura Mackner
• Collaborators: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: R01NR017533 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be archived with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR). NCH is a member of ICPSR via the Ohio State University; thus ICPSR can curate the data using funds provided by membership dues. ICPSR can archive the full dataset and its documentation, supporting the data through future changing technologies, new media, and data formats. ICPSR will make the data available to the broader research community via files that may be accessed directly via the ICPSR Web site. Approximately 776 universities, government agencies, and other institutions are members of ICPSR. Member institutions have full direct access to ICPSR's data archives and to all of ICPSR's services and can download the data. Non-members may purchase the files. The data will be deposited with the repository at the completion of the study and disseminated in one year to give the investigators time to publish their findings.
• IPD Sharing Time Frame: The data will be deposited with the repository at the completion of the study but not disseminated for one year to give the investigators time to publish their findings.
• IPD Sharing Access Criteria: Users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No