Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peer Mentoring to Improve Self-management in Youth With IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827109
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Rosalind Franklin University of Medicine and Science
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Laura Mackner, Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Pediatric Crohns Disease Pediatric Ulcerative Colitis Inflammatory Bowel Diseases 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 Not Applicable

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), with in-person contact 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peer Mentoring to Improve Self-management in Youth With IBD
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : February 23, 2023
Estimated Study Completion Date : February 23, 2023


Arm Intervention/treatment
Experimental: Mentoring program
The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month. Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics.
Behavioral: 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.

Behavioral: IBD educational website
Website with age-appropriate educational information, including information from the group educational activities.

Behavioral: 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). For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.

Behavioral: Mentor
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.

Behavioral: Fun 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.

Behavioral: Parent support group
Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing during group events.

Active Comparator: Educational activity program
The Educational Activity comparison group consists of separate educational group events on the same topics (with no social time), educational information posted online, and monthly encouragement to engage in activities in the community.
Behavioral: 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.

Behavioral: IBD educational website
Website with age-appropriate educational information, including information from the group educational activities.

Behavioral: 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). For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 18 month change from baseline Youth quality of life: PedsQL [ Time Frame: Baseline to 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. 12 month Youth disease outcomes - Crohn's Disease severity [ Time Frame: 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.

  2. 12 month Youth disease outcomes - Ulcerative Colitis severity [ Time Frame: 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.

  3. 18 month Youth disease outcomes - Crohn's Disease severity [ Time Frame: 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.

  4. 18 month Youth disease outcomes - Ulcerative Colitis severity [ Time Frame: 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.

  5. 12 month number of hospital admissions in previous 6 months [ Time Frame: 12 months post mentor-mentee introduction ]
    12 month number of hospital admissions in previous 6 months

  6. 18 month number of hospital admissions in previous 6 months [ Time Frame: 18 months post mentor-mentee introduction ]
    18 month number of hospital admissions in previous 6 months

  7. 12 month number of clinic appointments in previous 6 months [ Time Frame: 12 months post mentor-mentee introduction ]
    12 month number of clinic appointments in previous 6 months

  8. 18 month number of clinic appointments in previous 6 months [ Time Frame: 18 months post mentor-mentee introduction ]
    18 month number of clinic appointments in previous 6 months

  9. 12 month number of missed appointments in previous 6 months [ Time Frame: 12 months post mentor-mentee introduction ]
    12 month number of missed appointments in previous 6 months

  10. 18 month number of missed appointments in previous 6 months [ Time Frame: 18 months post mentor-mentee introduction ]
    18 month number of missed appointments in previous 6 months

  11. 12 month number of procedures in previous 6 months [ Time Frame: 12 months post mentor-mentee introduction ]
    12 month number of procedures appointments in previous 6 months

  12. 18 month number of procedures in previous 6 months [ Time Frame: 18 months post mentor-mentee introduction ]
    18 month number of procedures appointments in previous 6 months

  13. 12 months Mentor QOL [ Time Frame: 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.

  14. 18 months Mentor QOL [ Time Frame: 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.

  15. 12 month change from baseline Mentor QOL [ Time Frame: 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.

  16. 12 month Parent QOL [ Time Frame: 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.

  17. 12 month change from baseline Parent QOL [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827109


Contacts
Layout table for location contacts
Contact: Laura Mackner, PhD 614-722-4716 Laura.Mackner@nationwidechildrens.org

Locations
Layout table for location information
United States, Ohio
Abigail Wexner Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Laura Mackner, PhD    614-722-4716    Laura.Mackner@nationwidechildrens.org   
Sponsors and Collaborators
Laura Mackner
Children's Hospital Medical Center, Cincinnati
Rosalind Franklin University of Medicine and Science
Children's Hospital and Health System Foundation, Wisconsin
  Study Documents (Full-Text)

Documents provided by Laura Mackner, Nationwide Children's Hospital:
Informed Consent Form  [PDF] April 26, 2019

Layout table for additonal information
Responsible Party: Laura Mackner, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03827109    
Other Study ID Numbers: R01NR017533 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be archived with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR). NCH is a member of ICPSR via the Ohio State University; thus ICPSR can curate the data using funds provided by membership dues. ICPSR can archive the full dataset and its documentation, supporting the data through future changing technologies, new media, and data formats. ICPSR will make the data available to the broader research community via files that may be accessed directly via the ICPSR Web site. Approximately 776 universities, government agencies, and other institutions are members of ICPSR. Member institutions have full direct access to ICPSR's data archives and to all of ICPSR's services and can download the data. Non-members may purchase the files. The data will be deposited with the repository at the completion of the study and disseminated in one year to give the investigators time to publish their findings.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: The data will be deposited with the repository at the completion of the study but not disseminated for one year to give the investigators time to publish their findings.
Access Criteria: Users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases