Clinical trial NCT03827109: Peer Mentoring to Improve Self-management in Youth With IBD
Official title: Peer Mentoring to Improve Self-management in Youth With IBD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Crohns Disease
Pediatric Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2019-02-01
Enrollment: 79
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 12 month youth quality of life: PedsQL
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month youth quality of life: PedsQL
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month change from baseline Youth quality of life: PedsQL
timeFrame: Baseline to 12 months post mentor-mentee introduction
measure: 18 month change from baseline Youth quality of life: PedsQL
timeFrame: Baseline to 18 months post mentor-mentee introduction
measure: 12 month youth functional disability
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month youth functional disability
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month change from baseline youth functional disability
timeFrame: Baseline to 12 months post mentor-mentee introduction
measure: 18 month change from baseline youth functional disability
timeFrame: Baseline to 18 months post mentor-mentee introduction
Secondary outcomes:
measure: 12 month Youth disease outcomes - Crohn's Disease severity
timeFrame: 12 months post mentor-mentee introduction
measure: 12 month Youth disease outcomes - Ulcerative Colitis severity
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month Youth disease outcomes - Crohn's Disease severity
timeFrame: 18 months post mentor-mentee introduction
measure: 18 month Youth disease outcomes - Ulcerative Colitis severity
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month number of hospital admissions in previous 6 months
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month number of hospital admissions in previous 6 months
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month number of clinic appointments in previous 6 months
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month number of clinic appointments in previous 6 months
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month number of missed appointments in previous 6 months
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month number of missed appointments in previous 6 months
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month number of procedures in previous 6 months
timeFrame: 12 months post mentor-mentee introduction
measure: 18 month number of procedures in previous 6 months
timeFrame: 18 months post mentor-mentee introduction
measure: 12 months Mentor QOL
timeFrame: 12 months post mentor-mentee introduction
measure: 18 months Mentor QOL
timeFrame: 18 months post mentor-mentee introduction
measure: 12 month change from baseline Mentor QOL
timeFrame: Baseline to 12 months post mentor-mentee introduction
measure: 12 month Parent QOL
timeFrame: 12 months post mentor-mentee introduction
measure: 12 month change from baseline Parent QOL
timeFrame: Baseline to 12 months post mentor-mentee introduction
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Abigail Wexner Research Institute at Nationwide Children's Hospital
state: Ohio
Study officials:
References: