Ignite Creation Date:
2024-05-06 @ 12:41 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03827109
Status:
TERMINATED
Last Update Posted:
2024-05-16
First Post:
2019-01-14
Brief Title:
Peer Mentoring to Improve Self-management in Youth With IBD
Sponsor:
Kelly Boone
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Peer Mentoring to Improve Self-management in Youth With IBD
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator resignation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 mentee-mentor relationships with group educational activities online educational information and a parent support component Mentors and mentees are expected to have weekly contact eg 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
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 11 mentee-mentor relationships with group educational activities online educational information and a parent support component Mentors and mentees are expected to have weekly contact eg 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 PIs 10 years of experience with Big Brothers Big Sisters It consists of year-long 11 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 eg 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 eg 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 socialsupport 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 eg the in-person mentor-mentee monthly activity can be conducted via Skype and group activities are live streamed
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 PIs 10 years of experience with Big Brothers Big Sisters It consists of year-long 11 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 eg 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 eg 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 socialsupport 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 eg the in-person mentor-mentee monthly activity can be conducted via Skype and group activities are live streamed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None