Pediatric Crohns Disease, Pediatric Ulcerative Colitis, Inflammatory Bowel Diseases
Conditions
Brief summary
This study is a multi-site randomized controlled clinical trial evaluating the efficacy of a peer mentoring program for improving the self-management of youth with IBD. The primary outcomes are youth QOL and functioning in typical life activities. Secondary outcomes are disease outcomes, including disease severity and clinical outcomes (hospital admissions, clinic appointments, missed appointments, procedures). Mentor and parent QOL will also be assessed as secondary outcomes. Mechanisms that may contribute to the effects of the Mentoring Program will be investigated: Parent and child self-efficacy, illness uncertainty, coping, social support and child perceived stigma. Sex will be explored as a moderator. A total of 200 youth and their parents and 100 mentors will be enrolled. Eligibility criteria for youth include age 10-17 years, parent and child English fluency, and no documented neurodevelopmental disorder or history of hospitalization for a psychiatric or behavioral disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing their IBD well. They will be rigorously screened via online application, interview, checks of references, driving records, and social media, background check, and successful completion of a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an Educational Activity comparison group, with baseline assessments occurring prior to randomization. Follow-up assessments will occur post-intervention and 6 months later. The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month. Group activities target self-management skills through experiential opportunities, modeling, and direct instruction. Educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. The Educational Activity comparison group consists of separate educational group events on the same topics (with no social time), educational information posted online, and monthly encouragement to engage in activities in the community.
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.
Interventions
BEHAVIORALGroup educational activities
Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.
BEHAVIORALIBD educational website
Website with age-appropriate educational information, including information from the group educational activities.
BEHAVIORALMonthly check-in calls from program coordinator
Phone calls from coordinator to encourage youth to do something fun with a friend (comparison group) or mentor (Mentoring Program). During the COVID-19 pandemic, virtual activities are encouraged. For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.
BEHAVIORALMentor
Mentees will be matched with a mentor for a year-long, 1:1 mentee-mentor relationship. Matching mentors and mentees is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month, one of which can be attending a group activity together. Due to the COVID-19 pandemic, a modification was approved so that all study activities can be conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via Skype, and group activities are live streamed
BEHAVIORALFun group activities
Program participants vote on fun group activities to participate in for support and to learn self-management skills through experiential opportunities and modeling. These are live streamed during the COVID-19 pandemic.
BEHAVIORALParent support group
Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing during group events (virtually during the COVID-19 pandemic).
Sponsors
Children's Hospital Medical Center, Cincinnati
Kelly Boone
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Mentees: * Diagnosis of IBD * Age 10 - 17 years * Parent and child English fluency * No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder Mentors: * ≥16 years * ≥1 year post-diagnosis of IBD * Managing their IBD well * Pass a screening that includes an online application, interview, 3 character references, checks of driving records and social media, background check, mentor training
Exclusion criteria
Mentees: No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Youth Quality of Life: PedsQL | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Number of Missed Appointments in Previous 6 Months | 12 months post mentor-mentee introduction | 12 month number of missed appointments in previous 6 months |
| 18 Month Number of Missed Appointments in Previous 6 Months | 18 months post mentor-mentee introduction | 18 month number of missed appointments in previous 6 months |
| 12 Month Number of Procedures in Previous 6 Months | 12 months post mentor-mentee introduction | 12 month number of procedures appointments in previous 6 months |
| 18 Month Number of Procedures in Previous 6 Months | 18 months post mentor-mentee introduction | 18 month number of procedures appointments in previous 6 months |
| 12 Month Youth Disease Outcomes - Crohn's Disease Severity | 12 months post mentor-mentee introduction | Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease. |
| 18 Months Mentor QOL | 18 months post mentor-mentee introduction | PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. |
| 12 Month Change From Baseline Mentor QOL | Baseline to 12 months post mentor-mentee introduction | PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. |
| 12 Month Parent QOL | 12 months post mentor-mentee introduction | PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. |
| 12 Month Change From Baseline Parent QOL | Baseline to 12 months post mentor-mentee introduction | PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. |
| 12 Months Mentor QOL | 12 months post mentor-mentee introduction | PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. |
| 12 Month Youth Disease Outcomes - Ulcerative Colitis Severity | 12 months post mentor-mentee introduction | Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease. |
| 18 Month Youth Disease Outcomes - Crohn's Disease Severity | 18 months post mentor-mentee introduction | Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease. |
| 18 Month Youth Disease Outcomes - Ulcerative Colitis Severity | 18 months post mentor-mentee introduction | Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease. |
| 12 Month Number of Hospital Admissions in Previous 6 Months | 12 months post mentor-mentee introduction | 12 month number of hospital admissions in previous 6 months |
| 18 Month Number of Hospital Admissions in Previous 6 Months | 18 months post mentor-mentee introduction | 18 month number of hospital admissions in previous 6 months |
| 12 Month Number of Clinic Appointments in Previous 6 Months | 12 months post mentor-mentee introduction | 12 month number of clinic appointments in previous 6 months |
| 18 Month Number of Clinic Appointments in Previous 6 Months | 18 months post mentor-mentee introduction | 18 month number of clinic appointments in previous 6 months |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. Due to the COVID-19 pandemic, these activities can be conducted virtually. | 55 |
| 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.
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. | 56 |
| 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. | 55 |
| 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. | 56 |
| 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. | 63 |
| Total | 285 |
Baseline characteristics
| Characteristic | Total | Educational Activity Program (Child) | Mentoring Program (Child) | Mentors | Mentoring Program (Parent) | Educational Activity Program (Parent) |
|---|---|---|---|---|---|---|
| Age, Customized Participant Age | 12.7 Years STANDARD_DEVIATION 1.8 | 12.2 Years STANDARD_DEVIATION 2 | 11.8 Years STANDARD_DEVIATION 1.6 | 21 Years STANDARD_DEVIATION 5.1 | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 6 Participants | 7 Participants | 4 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 2 Participants | 7 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 221 Participants | 47 Participants | 38 Participants | 54 Participants | 39 Participants | 43 Participants |
| Region of Enrollment United States | 285 participants | 56 participants | 55 participants | 63 participants | 55 participants | 56 participants |
| Sex: Female, Male Female | 204 Participants | 22 Participants | 25 Participants | 46 Participants | 55 Participants | 56 Participants |
| Sex: Female, Male Male | 81 Participants | 34 Participants | 30 Participants | 17 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 63 |
| other Total, other adverse events | 7 / 55 | 5 / 56 | 0 / 55 | 0 / 56 | 0 / 63 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 63 |
Outcome results
Primary
12 Month Change From Baseline Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Time frame: Baseline to 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Change From Baseline Youth Functional Disability | 0 Participants |
| Educational Activity Program | 12 Month Change From Baseline Youth Functional Disability | 0 Participants |
Primary
12 Month Change From Baseline Youth Quality of Life: PedsQL
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: Baseline to 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Change From Baseline Youth Quality of Life: PedsQL | 0 Participants |
| Educational Activity Program | 12 Month Change From Baseline Youth Quality of Life: PedsQL | 0 Participants |
Primary
12 Month Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Youth Functional Disability | 0 Participants |
| Educational Activity Program | 12 Month Youth Functional Disability | 0 Participants |
Primary
12 Month Youth Quality of Life: PedsQL
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Youth Quality of Life: PedsQL | 0 Participants |
| Educational Activity Program | 12 Month Youth Quality of Life: PedsQL | 0 Participants |
Primary
18 Month Change From Baseline Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Time frame: Baseline to 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Change From Baseline Youth Functional Disability | 0 Participants |
| Educational Activity Program | 18 Month Change From Baseline Youth Functional Disability | 0 Participants |
Primary
18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical
Pediatric Quality of Life Inventory (PedsQL), Physical Domain (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used. Score below reflects change from baseline to 18-months post mentor-mentee introduction, with higher absolute values reflecting greater change.
Time frame: Baseline to 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical | 0 Participants |
| Educational Activity Program | 18 Month Change From Baseline Youth Quality of Life: PedsQL: Physical | 0 Participants |
Primary
18 Month Youth Functional Disability
Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Youth Functional Disability | 0 Participants |
| Educational Activity Program | 18 Month Youth Functional Disability | 0 Participants |
Primary
18 Month Youth Quality of Life: PedsQL
PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Youth Quality of Life: PedsQL | 0 Participants |
| Educational Activity Program | 18 Month Youth Quality of Life: PedsQL | 0 Participants |
Secondary
12 Month Change From Baseline Mentor QOL
PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: Baseline to 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Change From Baseline Mentor QOL | 0 Participants |
Secondary
12 Month Change From Baseline Parent QOL
PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: Baseline to 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Change From Baseline Parent QOL | 0 Participants |
Secondary
12 Month Number of Clinic Appointments in Previous 6 Months
12 month number of clinic appointments in previous 6 months
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Number of Clinic Appointments in Previous 6 Months | 0 Participants |
| Educational Activity Program | 12 Month Number of Clinic Appointments in Previous 6 Months | 0 Participants |
Secondary
12 Month Number of Hospital Admissions in Previous 6 Months
12 month number of hospital admissions in previous 6 months
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Number of Hospital Admissions in Previous 6 Months | 0 Participants |
| Educational Activity Program | 12 Month Number of Hospital Admissions in Previous 6 Months | 0 Participants |
Secondary
12 Month Number of Missed Appointments in Previous 6 Months
12 month number of missed appointments in previous 6 months
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Number of Missed Appointments in Previous 6 Months | 0 Participants |
| Educational Activity Program | 12 Month Number of Missed Appointments in Previous 6 Months | 0 Participants |
Secondary
12 Month Number of Procedures in Previous 6 Months
12 month number of procedures appointments in previous 6 months
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Number of Procedures in Previous 6 Months | 0 Participants |
| Educational Activity Program | 12 Month Number of Procedures in Previous 6 Months | 0 Participants |
Secondary
12 Month Parent QOL
PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Parent QOL | 0 Participants |
Secondary
12 Months Mentor QOL
PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Months Mentor QOL | 0 Participants |
| Educational Activity Program | 12 Months Mentor QOL | 0 Participants |
Secondary
12 Month Youth Disease Outcomes - Crohn's Disease Severity
Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Youth Disease Outcomes - Crohn's Disease Severity | 0 Participants |
| Educational Activity Program | 12 Month Youth Disease Outcomes - Crohn's Disease Severity | 0 Participants |
Secondary
12 Month Youth Disease Outcomes - Ulcerative Colitis Severity
Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.
Time frame: 12 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 12 Month Youth Disease Outcomes - Ulcerative Colitis Severity | 0 Participants |
| Educational Activity Program | 12 Month Youth Disease Outcomes - Ulcerative Colitis Severity | 0 Participants |
Secondary
18 Month Number of Clinic Appointments in Previous 6 Months
18 month number of clinic appointments in previous 6 months
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Number of Clinic Appointments in Previous 6 Months | 0 Participants |
| Educational Activity Program | 18 Month Number of Clinic Appointments in Previous 6 Months | 0 Participants |
Secondary
18 Month Number of Hospital Admissions in Previous 6 Months
18 month number of hospital admissions in previous 6 months
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Number of Hospital Admissions in Previous 6 Months | 0 Participants |
| Educational Activity Program | 18 Month Number of Hospital Admissions in Previous 6 Months | 0 Participants |
Secondary
18 Month Number of Missed Appointments in Previous 6 Months
18 month number of missed appointments in previous 6 months
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Number of Missed Appointments in Previous 6 Months | 0 Participants |
| Educational Activity Program | 18 Month Number of Missed Appointments in Previous 6 Months | 0 Participants |
Secondary
18 Month Number of Procedures in Previous 6 Months
18 month number of procedures appointments in previous 6 months
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Number of Procedures in Previous 6 Months | 0 Participants |
| Educational Activity Program | 18 Month Number of Procedures in Previous 6 Months | 0 Participants |
Secondary
18 Months Mentor QOL
PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Months Mentor QOL | 0 Participants |
Secondary
18 Month Youth Disease Outcomes - Crohn's Disease Severity
Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Youth Disease Outcomes - Crohn's Disease Severity | 0 Participants |
| Educational Activity Program | 18 Month Youth Disease Outcomes - Crohn's Disease Severity | 0 Participants |
Secondary
18 Month Youth Disease Outcomes - Ulcerative Colitis Severity
Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.
Time frame: 18 months post mentor-mentee introduction
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mentoring Program | 18 Month Youth Disease Outcomes - Ulcerative Colitis Severity | 0 Participants |
| Educational Activity Program | 18 Month Youth Disease Outcomes - Ulcerative Colitis Severity | 0 Participants |