Study Stopped
Principal Investigator resignation.
Peer Mentoring to Improve Self-management in Youth With IBD
1 other identifier
interventional
79
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedResults Posted
Study results publicly available
January 13, 2026
CompletedJanuary 13, 2026
August 1, 2025
4.7 years
January 14, 2019
August 8, 2025
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
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: Physical
Pediatric Quality of Life Inventory (PedsQL), Physical Domain (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. Score below reflects change from baseline to 18-months post mentor-mentee introduction, with higher absolute values reflecting greater change.
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 Outcomes (17)
12 Month Youth Disease Outcomes - Crohn's Disease Severity
12 months post mentor-mentee introduction
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity
12 months post mentor-mentee introduction
18 Month Youth Disease Outcomes - Crohn's Disease Severity
18 months post mentor-mentee introduction
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity
18 months post mentor-mentee introduction
12 Month Number of Hospital Admissions in Previous 6 Months
12 months post mentor-mentee introduction
- +12 more secondary outcomes
Study Arms (2)
Mentoring program
EXPERIMENTALThe 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.
Educational activity program
ACTIVE COMPARATORThe 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.
Interventions
Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.
Website with age-appropriate educational information, including information from the group educational activities.
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
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Mentees: No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kelly Boonelead
- Children's Hospital Medical Center, Cincinnaticollaborator
Study Sites (1)
Abigail Wexner Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
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.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kelly Boone
- Organization
- Abigail Wexner Research Institute at Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 14, 2019
First Posted
February 1, 2019
Study Start
June 12, 2019
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
January 13, 2026
Results First Posted
January 13, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- 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.
- 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.
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.