Pediatric Crohns DiseaseNCT03827109
Peer Mentoring to Improve Self-management in Youth With IBD
A study testing Group educational activities, IBD educational website and Monthly check-in calls from program coordinator in people with Pediatric Crohns Disease and Pediatric Ulcerative Colitis, run by Kelly Boone at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Crohns Disease, Pediatric Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Group educational activities, IBD educational website and Monthly check-in calls from program coordinator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 10Show fewer
- ≥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
Who cannot join
- Mentees: No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Abigail Wexner Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read more
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.
- Being tested
- Group educational activities, IBD educational website, Monthly check-in calls from program coordinator, Mentor, Fun group activities
- Medical subject headings
- Pediatric ulcerative colitis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group educational activitiesBehavioural
Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.
IBD educational websiteBehavioural
Website with age-appropriate educational information, including information from the group educational activities.
Monthly check-in calls from program coordinatorBehavioural
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.
MentorBehavioural
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
Fun group activitiesBehavioural
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.
Parent support groupBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Mentoring program | Experimental | 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. Receives: 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 |
| Educational activity program | Active comparator | 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. Receives: Behavioral: Group educational activities; Behavioral: IBD educational website; Behavioral: Monthly check-in calls from program coordinator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post mentor-mentee introduction
18 Month Youth Quality of Life: PedsQL
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: 18 months post mentor-mentee introduction
12 Month Change From Baseline Youth Quality of Life: PedsQL
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: Baseline to 12 months post mentor-mentee introduction
18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical
Pediatric Quality of Life Inventory (PedsQL), Physical Domain (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. Score below reflects change from baseline to 18-months post mentor-mentee introduction, with higher absolute values reflecting greater change.
Measured: Baseline to 18 months post mentor-mentee introduction
12 Month Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Measured: 12 months post mentor-mentee introduction
18 Month Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Measured: 18 months post mentor-mentee introduction
12 Month Change From Baseline Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Measured: Baseline to 12 months post mentor-mentee introduction
18 Month Change From Baseline Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Measured: Baseline to 18 months post mentor-mentee introduction
Secondary outcomes (17)
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.
Measured: 12 months post mentor-mentee introduction
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity
Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.
Measured: 12 months post mentor-mentee introduction
18 Month Youth Disease Outcomes - Crohn's Disease Severity
Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.
Measured: 18 months post mentor-mentee introduction
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity
Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.
Measured: 18 months post mentor-mentee introduction
12 Month Number of Hospital Admissions in Previous 6 Months
12 month number of hospital admissions in previous 6 months
Measured: 12 months post mentor-mentee introduction
18 Month Number of Hospital Admissions in Previous 6 Months
18 month number of hospital admissions in previous 6 months
Measured: 18 months post mentor-mentee introduction
12 Month Number of Clinic Appointments in Previous 6 Months
12 month number of clinic appointments in previous 6 months
Measured: 12 months post mentor-mentee introduction
18 Month Number of Clinic Appointments in Previous 6 Months
18 month number of clinic appointments in previous 6 months
Measured: 18 months post mentor-mentee introduction
12 Month Number of Missed Appointments in Previous 6 Months
12 month number of missed appointments in previous 6 months
Measured: 12 months post mentor-mentee introduction
18 Month Number of Missed Appointments in Previous 6 Months
18 month number of missed appointments in previous 6 months
Measured: 18 months post mentor-mentee introduction
12 Month Number of Procedures in Previous 6 Months
12 month number of procedures appointments in previous 6 months
Measured: 12 months post mentor-mentee introduction
18 Month Number of Procedures in Previous 6 Months
18 month number of procedures appointments in previous 6 months
Measured: 18 months post mentor-mentee introduction
12 Months Mentor QOL
PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: 12 months post mentor-mentee introduction
18 Months Mentor QOL
PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: 18 months post mentor-mentee introduction
12 Month Change From Baseline Mentor QOL
PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: Baseline to 12 months post mentor-mentee introduction
12 Month Parent QOL
PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: 12 months post mentor-mentee introduction
12 Month Change From Baseline Parent QOL
PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Measured: Baseline to 12 months post mentor-mentee introduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start12 Jun 2019
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Principal Investigator resignation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Crohns DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelly Boone
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor-investigator, Kelly Boone, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827109
- Sponsor's protocol ID
- R01NR017533
- Status last verified
- Aug 2025
- First submitted
- 14 Jan 2019
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Mentoring to Improve Self-management in Youth With IBD
- ClinicalTrials.gov ID
- NCT03827109
- Acronym / sponsor ID
- R01NR017533
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator resignation.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Kelly BooneUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study is a multi-site randomized controlled clinical trial evaluating the efficacy of a peer mentoring program for improving the self-management of youth with IBD. The primary outcomes are youth QOL and functioning in typical life activities, which can remain significantly impaired even when the disease is in remission, but have received little empirical attention. Secondary outcomes are disease outcomes, including disease severity and clinical outcomes (hospital admissions, clinic appointments, missed appointments, procedures). Mentor and parent QOL will also be assessed as secondary outcomes. Mechanisms that may contribute to the effects of the Mentoring Program will be investigated: Parent and child self-efficacy, illness uncertainty, coping, social support and child perceived stigma may mediate relationships between mentoring and outcomes. Sex will be explored as a moderator.
A total of 200 youth and their parents and 100 mentors will be enrolled in the study. Eligibility criteria for youth include age 10-17 years, parent and child English fluency, and no documented neurodevelopmental disorder or history of hospitalization for a psychiatric or behavioral disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing their IBD well. They will be rigorously screened via online application, interview, checks of references, driving records, and social media, background check, and successful completion of a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an "Educational Activity" comparison group, with baseline assessments occurring prior to randomization. Follow-up assessments will occur post-intervention and 6 months later. Youth in the Educational Activity group will be yoked to those in Mentoring Program, and the timing of their follow-up assessments will correspond to their yoked peer.
The Mentoring Program was developed via focus groups, an NIH-funded pilot study, national mentoring resources, and the PI's 10 years of experience with Big Brothers Big Sisters. It consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Matching mentors and mentees is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and mentees are expected to have weekly contact (e.g., text, phone), as well as participate in an activity (in person or virtually) 1 - 2 times per month, one of which can be attending a group activity together. The investigators expect the relationship to last 1 year, which is associated with better outcomes than shorter relationships.
Group activities target self-management skills through experiential opportunities, modeling, and direct instruction. Educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area (e.g., dietitian, pediatric gastroenterologists). They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents in the Mentoring Program participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics.
The Educational Activity comparison group consists of separate educational group events on the same topics (with no social or support time), educational information posted online, and monthly encouragement to engage in activities in the community.
Due to the COVID-19 pandemic, a modification was approved so that all study activities can be conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via Skype, and group activities are live streamed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentoring program | Experimental | 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 groupThe Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month. Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics. Due to the COVID-19 pandemic, these activities can be conducted virtually. |
| Educational activity program | Active comparator | Behavioral: Group educational activities, Behavioral: IBD educational website, Behavioral: Monthly check-in calls from program coordinatorThe 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
- ≥16 years
Key exclusion criteria (1 listed)
- Mentees: No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group educational activitiesGroup educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s. | Behavioural | Educational activity program, Mentoring program |
| IBD educational websiteWebsite with age-appropriate educational information, including information from the group educational activities. | Behavioural | Educational activity program, Mentoring program |
| Monthly check-in calls from program coordinatorPhone 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. | Behavioural | Educational activity program, Mentoring program |
| MentorMentees 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 | Behavioural | Mentoring program |
| Fun group activitiesProgram 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. | Behavioural | Mentoring program |
| Parent support groupParents 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). | Behavioural | Mentoring program |
Primary outcome
12 Month Youth Quality of Life: PedsQL
Time frame: 12 months post mentor-mentee introduction
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
18 Month Youth Quality of Life: PedsQL
Time frame: 18 months post mentor-mentee introduction
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
12 Month Change From Baseline Youth Quality of Life: PedsQL
Time frame: Baseline to 12 months post mentor-mentee introduction
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical
Time frame: Baseline to 18 months post mentor-mentee introduction
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.
12 Month Youth Functional Disability
Time frame: 12 months post mentor-mentee introduction
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
18 Month Youth Functional Disability
Time frame: 18 months post mentor-mentee introduction
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
12 Month Change From Baseline Youth Functional Disability
Time frame: Baseline to 12 months post mentor-mentee introduction
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
18 Month Change From Baseline Youth Functional Disability
Time frame: Baseline to 18 months post mentor-mentee introduction
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.
17 secondary outcomes
12 Month Youth Disease Outcomes - Crohn's Disease Severity
Time frame: 12 months post mentor-mentee introduction
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity
Time frame: 12 months post mentor-mentee introduction
18 Month Youth Disease Outcomes - Crohn's Disease Severity
Time frame: 18 months post mentor-mentee introduction
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity
Time frame: 18 months post mentor-mentee introduction
12 Month Number of Hospital Admissions in Previous 6 Months
Time frame: 12 months post mentor-mentee introduction
18 Month Number of Hospital Admissions in Previous 6 Months
Time frame: 18 months post mentor-mentee introduction
12 Month Number of Clinic Appointments in Previous 6 Months
Time frame: 12 months post mentor-mentee introduction
18 Month Number of Clinic Appointments in Previous 6 Months
Time frame: 18 months post mentor-mentee introduction
12 Month Number of Missed Appointments in Previous 6 Months
Time frame: 12 months post mentor-mentee introduction
18 Month Number of Missed Appointments in Previous 6 Months
Time frame: 18 months post mentor-mentee introduction
12 Month Number of Procedures in Previous 6 Months
Time frame: 12 months post mentor-mentee introduction
18 Month Number of Procedures in Previous 6 Months
Time frame: 18 months post mentor-mentee introduction
12 Months Mentor QOL
Time frame: 12 months post mentor-mentee introduction
18 Months Mentor QOL
Time frame: 18 months post mentor-mentee introduction
12 Month Change From Baseline Mentor QOL
Time frame: Baseline to 12 months post mentor-mentee introduction
12 Month Parent QOL
Time frame: 12 months post mentor-mentee introduction
12 Month Change From Baseline Parent QOL
Time frame: Baseline to 12 months post mentor-mentee introduction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40243391Tiles-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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group educational activities, IBD educational website and Monthly check-in calls from program coordinator in people with Pediatric Crohns Disease and Pediatric Ulcerative Colitis, run by Kelly Boone at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 Month Youth Quality of Life: PedsQL (time frame: 12 months post mentor-mentee introduction). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.