CClinicalTrials.gg
TerminatedNCT03827109Updated Jan 13, 2026Results posted

Peer Mentoring to Improve Self-management in Youth With IBD

An interventional study of Group educational activities and IBD educational website in Pediatric Crohns Disease, Pediatric Ulcerative Colitis and Inflammatory Bowel Diseases, sponsored by Kelly Boone. Terminated at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Kelly Boone · Not applicable, Interventional, and Prevention

Why this study was terminated
Principal Investigator resignation.
Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pediatric Crohns Disease
  • Pediatric Ulcerative Colitis
  • Inflammatory Bowel Diseases
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 79 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

This is the only study on the registry with Kelly Boone as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • 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 · Behavioral: IBD educational website · Behavioral: Monthly check-in calls from program coordinator · Behavioral: Mentor · Behavioral: Fun group activities · Behavioral: Parent support group

  • 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 · Behavioral: IBD educational website · Behavioral: Monthly check-in calls from program coordinator

Interventions

  • BehavioralGroup educational activities

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

  • BehavioralIBD educational website

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

  • BehavioralMonthly 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.

  • BehavioralMentor

    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

  • BehavioralFun 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.

  • BehavioralParent 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months post mentor-mentee introduction

  2. 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.

    Time frame: 18 months post mentor-mentee introduction

  3. 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.

    Time frame: Baseline to 12 months post mentor-mentee introduction

  4. 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.

    Time frame: Baseline to 18 months post mentor-mentee introduction

  5. 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.

    Time frame: 12 months post mentor-mentee introduction

  6. 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.

    Time frame: 18 months post mentor-mentee introduction

  7. 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.

    Time frame: Baseline to 12 months post mentor-mentee introduction

  8. 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.

    Time frame: Baseline to 18 months post mentor-mentee introduction

Secondary outcomes

  1. 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.

    Time frame: 12 months post mentor-mentee introduction

  2. 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.

    Time frame: 12 months post mentor-mentee introduction

  3. 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.

    Time frame: 18 months post mentor-mentee introduction

  4. 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.

    Time frame: 18 months post mentor-mentee introduction

  5. 12 Month Number of Hospital Admissions in Previous 6 Months

    12 month number of hospital admissions in previous 6 months

    Time frame: 12 months post mentor-mentee introduction

  6. 18 Month Number of Hospital Admissions in Previous 6 Months

    18 month number of hospital admissions in previous 6 months

    Time frame: 18 months post mentor-mentee introduction

  7. 12 Month Number of Clinic Appointments in Previous 6 Months

    12 month number of clinic appointments in previous 6 months

    Time frame: 12 months post mentor-mentee introduction

  8. 18 Month Number of Clinic Appointments in Previous 6 Months

    18 month number of clinic appointments in previous 6 months

    Time frame: 18 months post mentor-mentee introduction

  9. 12 Month Number of Missed Appointments in Previous 6 Months

    12 month number of missed appointments in previous 6 months

    Time frame: 12 months post mentor-mentee introduction

  10. 18 Month Number of Missed Appointments in Previous 6 Months

    18 month number of missed appointments in previous 6 months

    Time frame: 18 months post mentor-mentee introduction

  11. 12 Month Number of Procedures in Previous 6 Months

    12 month number of procedures appointments in previous 6 months

    Time frame: 12 months post mentor-mentee introduction

  12. 18 Month Number of Procedures in Previous 6 Months

    18 month number of procedures appointments in previous 6 months

    Time frame: 18 months post mentor-mentee introduction

  13. 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.

    Time frame: 12 months post mentor-mentee introduction

  14. 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.

    Time frame: 18 months post mentor-mentee introduction

  15. 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.

    Time frame: Baseline to 12 months post mentor-mentee introduction

  16. 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.

    Time frame: 12 months post mentor-mentee introduction

  17. 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.

    Time frame: Baseline to 12 months post mentor-mentee introduction

07

Results

Posted Jan 13, 2026

Participant flow

Participant flow — Overall Study
MilestoneMentoring Program (Child)Educational Activity Program (Child)Mentoring Program (Parent)Educational Activity Program (Parent)Mentors
Started5556555663
Completed4039000
Not completed1517555663

Outcome measures

Primary12 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.

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Youth Quality of Life: PedsQL
ParticipantsMentoring ProgramEducational Activity Program
12 Month Youth Quality of Life: PedsQL00
Primary18 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.

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Youth Quality of Life: PedsQL
ParticipantsMentoring ProgramEducational Activity Program
18 Month Youth Quality of Life: PedsQL00
Primary12 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.

Time frame:
Baseline to 12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Change From Baseline Youth Quality of Life: PedsQL
ParticipantsMentoring ProgramEducational Activity Program
12 Month Change From Baseline Youth Quality of Life: PedsQL00
Primary18 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.

Time frame:
Baseline to 18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical
ParticipantsMentoring ProgramEducational Activity Program
18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical00
Primary12 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.

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Youth Functional Disability
ParticipantsMentoring ProgramEducational Activity Program
12 Month Youth Functional Disability00
Primary18 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.

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Youth Functional Disability
ParticipantsMentoring ProgramEducational Activity Program
18 Month Youth Functional Disability00
Primary12 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.

Time frame:
Baseline to 12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Change From Baseline Youth Functional Disability
ParticipantsMentoring ProgramEducational Activity Program
12 Month Change From Baseline Youth Functional Disability00
Primary18 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.

Time frame:
Baseline to 18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Change From Baseline Youth Functional Disability
ParticipantsMentoring ProgramEducational Activity Program
18 Month Change From Baseline Youth Functional Disability00
Secondary12 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.

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Youth Disease Outcomes - Crohn's Disease Severity
ParticipantsMentoring ProgramEducational Activity Program
12 Month Youth Disease Outcomes - Crohn's Disease Severity00
Secondary12 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.

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity
ParticipantsMentoring ProgramEducational Activity Program
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity00
Secondary18 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.

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Youth Disease Outcomes - Crohn's Disease Severity
ParticipantsMentoring ProgramEducational Activity Program
18 Month Youth Disease Outcomes - Crohn's Disease Severity00
Secondary18 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.

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity
ParticipantsMentoring ProgramEducational Activity Program
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity00
Secondary12 Month Number of Hospital Admissions in Previous 6 Months

12 month number of hospital admissions in previous 6 months

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Number of Hospital Admissions in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
12 Month Number of Hospital Admissions in Previous 6 Months00
Secondary18 Month Number of Hospital Admissions in Previous 6 Months

18 month number of hospital admissions in previous 6 months

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Number of Hospital Admissions in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
18 Month Number of Hospital Admissions in Previous 6 Months00
Secondary12 Month Number of Clinic Appointments in Previous 6 Months

12 month number of clinic appointments in previous 6 months

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Number of Clinic Appointments in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
12 Month Number of Clinic Appointments in Previous 6 Months00
Secondary18 Month Number of Clinic Appointments in Previous 6 Months

18 month number of clinic appointments in previous 6 months

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Number of Clinic Appointments in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
18 Month Number of Clinic Appointments in Previous 6 Months00
Secondary12 Month Number of Missed Appointments in Previous 6 Months

12 month number of missed appointments in previous 6 months

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Number of Missed Appointments in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
12 Month Number of Missed Appointments in Previous 6 Months00
Secondary18 Month Number of Missed Appointments in Previous 6 Months

18 month number of missed appointments in previous 6 months

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Number of Missed Appointments in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
18 Month Number of Missed Appointments in Previous 6 Months00
Secondary12 Month Number of Procedures in Previous 6 Months

12 month number of procedures appointments in previous 6 months

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Number of Procedures in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
12 Month Number of Procedures in Previous 6 Months00
Secondary18 Month Number of Procedures in Previous 6 Months

18 month number of procedures appointments in previous 6 months

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Month Number of Procedures in Previous 6 Months
ParticipantsMentoring ProgramEducational Activity Program
18 Month Number of Procedures in Previous 6 Months00
Secondary12 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.

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Months Mentor QOL
ParticipantsMentoring ProgramEducational Activity Program
12 Months Mentor QOL00
Secondary18 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.

Time frame:
18 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
18 Months Mentor QOL
ParticipantsMentors
18 Months Mentor QOL0
Secondary12 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.

Time frame:
Baseline to 12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Change From Baseline Mentor QOL
ParticipantsMentors
12 Month Change From Baseline Mentor QOL0
Secondary12 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.

Time frame:
12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Parent QOL
ParticipantsParents
12 Month Parent QOL0
Secondary12 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.

Time frame:
Baseline to 12 months post mentor-mentee introduction
Reported as:
Count of participants · Participants
12 Month Change From Baseline Parent QOL
ParticipantsParents
12 Month Change From Baseline Parent QOL0

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mentoring Program (Child)0/55 (0%)0/55 (0%)7/55 (12.7%)
Educational Activity Program (Child)0/56 (0%)0/56 (0%)5/56 (8.9%)
Mentoring Program (Parent)0/55 (0%)0/55 (0%)0/55 (0%)
Educational Activity Program (Parent)0/56 (0%)0/56 (0%)0/56 (0%)
Mentors0/63 (0%)0/63 (0%)0/63 (0%)
Most frequent other events
Most frequent other events
EventMentoring Program (Child)Educational Activity Program (Child)Mentoring Program (Parent)Educational Activity Program (Parent)Mentors
COVID-19Infections and infestations5/553/56———
Other IllnessInfections and infestations3/552/56———
Worsening IBD SymptomsGastrointestinal disorders1/551/56———

Baseline characteristics

Age, Customized
Age, Customized(Years)Mentoring Program (Child)Educational Activity Program (Child)Mentoring Program (Parent)Educational Activity Program (Parent)MentorsTotal
Participant Age11.8 ± 1.612.2 ± 2.0——21 ± 5.112.7 ± 1.8
Sex: Female, Male
Sex: Female, Male(Participants)Mentoring Program (Child)Educational Activity Program (Child)Mentoring Program (Parent)Educational Activity Program (Parent)MentorsTotal
Female2522555646204
Male3034001781
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Mentoring Program (Child)Educational Activity Program (Child)Mentoring Program (Parent)Educational Activity Program (Parent)MentorsTotal
American Indian or Alaska Native100001
Asian212139
Native Hawaiian or Other Pacific Islander000000
Black or African American7676430
White3847394354221
More than one race7211213
Unknown or Not Reported0065011
Region of Enrollment
Region of Enrollment(participants)Mentoring Program (Child)Educational Activity Program (Child)Mentoring Program (Parent)Educational Activity Program (Parent)MentorsTotal
United States5556555663285
08

Study locations

1 site
  • Abigail Wexner Research Institute at Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
09

References and documents

Publications

  • 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. PubMed 40243391 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 2, 2018
  • Informed consent form · Apr 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03827109
Lead sponsor
Kelly Boone
Collaborators
Children's Hospital Medical Center, Cincinnati
Responsible party
Kelly Boone (Principal Investigator, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Feb 1, 2019
Start date
Jun 12, 2019
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Results posted
Jan 13, 2026
Last update
Jan 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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