Trial Outcomes & Findings for Peer Mentoring to Improve Self-management in Youth With IBD (NCT NCT03827109)
NCT ID: NCT03827109
Last Updated: 2026-01-13
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
12 months post mentor-mentee introduction
Results posted on
2026-01-13
Participant Flow
After recruitment, parents and youth will complete measures at baseline. Data will be collected in participants' homes to reduce the number of hospital visits required for families. Then they will be randomized into the mentoring program or comparison group.
Participant milestones
| Measure |
Mentoring Program (Child)
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.
|
Educational Activity Program (Child)
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
Mentoring Program (Parent)
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.
|
Educational Activity Program (Parent)
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.
Group educational activities: Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
Mentors
Mentors will facilitate group educational and socialization activities for children assigned to the mentorship program arm. Parents assigned to the mentorship program arm will join the mentors and mentees for educational topics.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
55
|
56
|
63
|
|
Overall Study
COMPLETED
|
40
|
39
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
55
|
56
|
63
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 Mentors' age data missing; Only participant age data from Children and Mentors was collected in this study.
Baseline characteristics by cohort
| Measure |
Mentoring Program (Child)
n=55 Participants
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.
|
Educational Activity Program (Child)
n=56 Participants
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.
Group educational activities: Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
Mentoring Program (Parent)
n=55 Participants
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.
|
Educational Activity Program (Parent)
n=56 Participants
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.
Group educational activities: Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
Mentors
n=63 Participants
Mentors will facilitate group educational and socialization activities for children assigned to the mentorship program arm. Parents assigned to the mentorship program arm will join the mentors and mentees for educational topics.
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Participant Age
|
11.8 Years
STANDARD_DEVIATION 1.6 • n=55 Participants • 3 Mentors' age data missing; Only participant age data from Children and Mentors was collected in this study.
|
12.2 Years
STANDARD_DEVIATION 2.0 • n=56 Participants • 3 Mentors' age data missing; Only participant age data from Children and Mentors was collected in this study.
|
—
|
—
|
21 Years
STANDARD_DEVIATION 5.1 • n=60 Participants • 3 Mentors' age data missing; Only participant age data from Children and Mentors was collected in this study.
|
12.7 Years
STANDARD_DEVIATION 1.8 • n=171 Participants • 3 Mentors' age data missing; Only participant age data from Children and Mentors was collected in this study.
|
|
Sex: Female, Male
Female
|
25 Participants
n=55 Participants
|
22 Participants
n=56 Participants
|
55 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
46 Participants
n=63 Participants
|
204 Participants
n=285 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=55 Participants
|
34 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
17 Participants
n=63 Participants
|
81 Participants
n=285 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
1 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
1 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
2 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
1 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
3 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
9 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
6 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
7 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
6 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
4 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
30 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Race (NIH/OMB)
White
|
38 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
47 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
39 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
43 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
54 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
221 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
2 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
1 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
1 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
2 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
13 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
6 Participants
n=55 Participants • Data related to participant race within each arm was not recorded until later time point.
|
5 Participants
n=56 Participants • Data related to participant race within each arm was not recorded until later time point.
|
0 Participants
n=63 Participants • Data related to participant race within each arm was not recorded until later time point.
|
11 Participants
n=285 Participants • Data related to participant race within each arm was not recorded until later time point.
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
56 participants
n=56 Participants
|
55 participants
n=55 Participants
|
56 participants
n=56 Participants
|
63 participants
n=63 Participants
|
285 participants
n=285 Participants
|
PRIMARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection and analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Youth Quality of Life: PedsQL
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Youth Quality of Life: PedsQL
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Change From Baseline Youth Quality of Life: PedsQL
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Youth Functional Disability
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Youth Functional Disability
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Change From Baseline Youth Functional Disability
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Change From Baseline Youth Functional Disability
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Youth Disease Outcomes - Crohn's Disease Severity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Youth Disease Outcomes - Crohn's Disease Severity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
12 month number of hospital admissions in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Number of Hospital Admissions in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
18 month number of hospital admissions in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Number of Hospital Admissions in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
12 month number of clinic appointments in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Number of Clinic Appointments in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
18 month number of clinic appointments in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Number of Clinic Appointments in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
12 month number of missed appointments in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Number of Missed Appointments in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
18 month number of missed appointments in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Number of Missed Appointments in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
12 month number of procedures appointments in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Number of Procedures in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
18 month number of procedures appointments in previous 6 months
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Month Number of Procedures in Previous 6 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Months Mentor QOL
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
18 Months Mentor QOL
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Change From Baseline Mentor QOL
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Parent QOL
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post mentor-mentee introductionPopulation: 0 participants analyzed due to early study termination. Study was terminated before data was collected, so no data was collected to analyze. Due to complications from the COVID-19 epidemic, research procedures related to data collection/analysis were significantly impacted and thus data collection/analysis did not occur before study closure.
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.
Outcome measures
| Measure |
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.
|
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
|---|---|---|
|
12 Month Change From Baseline Parent QOL
|
0 Participants
|
—
|
Adverse Events
Mentoring Program (Child)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Educational Activity Program (Child)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Mentoring Program (Parent)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educational Activity Program (Parent)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mentors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mentoring Program (Child)
n=55 participants at risk
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.
|
Educational Activity Program (Child)
n=56 participants at risk
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.
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.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
Mentoring Program (Parent)
n=55 participants at risk
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.
|
Educational Activity Program (Parent)
n=56 participants at risk
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.
Group educational activities: Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area.
IBD educational website: Website with age-appropriate educational information, including information from the group educational activities.
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.
|
Mentors
n=63 participants at risk
Mentors will facilitate group educational and socialization activities for children assigned to the mentorship program arm. Parents assigned to the mentorship program arm will join the mentors and mentees for educational topics.
|
|---|---|---|---|---|---|
|
Infections and infestations
Other Illness
|
5.5%
3/55 • Number of events 3 • 18 months
|
3.6%
2/56 • Number of events 2 • 18 months
|
0.00%
0/55 • 18 months
|
0.00%
0/56 • 18 months
|
0.00%
0/63 • 18 months
|
|
Infections and infestations
COVID-19
|
9.1%
5/55 • Number of events 8 • 18 months
|
5.4%
3/56 • Number of events 3 • 18 months
|
0.00%
0/55 • 18 months
|
0.00%
0/56 • 18 months
|
0.00%
0/63 • 18 months
|
|
Gastrointestinal disorders
Worsening IBD Symptoms
|
1.8%
1/55 • Number of events 1 • 18 months
|
1.8%
1/56 • Number of events 1 • 18 months
|
0.00%
0/55 • 18 months
|
0.00%
0/56 • 18 months
|
0.00%
0/63 • 18 months
|
Additional Information
Kelly Boone
Abigail Wexner Research Institute at Nationwide Children's Hospital
Phone: 614-722-3749
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place