Multimodal intervention consisting of four core components for Adolescent Development

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Adolescent Development+5 MoreMultimodal intervention consisting of four core components - Behavioral
Eligibility
16 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the effectiveness of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. The intervention includes individualized assessment, a transition navigator, and virtual patient skills-building and education programs.

Eligible Conditions
  • Adolescent Development
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Mental Health Wellness
  • Transition

Treatment Effectiveness

Study Objectives

0 Primary · 15 Secondary · Reporting Duration: 3 years

3 years
Emergency department visit after 18th birthday (yes/no)
Fecal calprotectin
Hospitalization after 18th birthday (yes/no)
Number of emergency department visits after 18th birthday
Number of outpatient visits to a gastroenterologist after 18th birthday
Month 24
IBD Disability Index (IBD-DI)
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
IBD-KID2
IBDQ-32
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Pediatric IBD INTERMED
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Physician Global Assessment (PGA)
Transition Readiness Assessment Questionnaire (TRAQ)
Transition Success Scores (TSS)

Trial Safety

Trial Design

1 Treatment Group

Intervention: Multimodal intervention consisting of four core components.
1 of 1

Experimental Treatment

115 Total Participants · 1 Treatment Group

Primary Treatment: Multimodal intervention consisting of four core components · No Placebo Group · N/A

Intervention: Multimodal intervention consisting of four core components.
Behavioral
Experimental Group · 1 Intervention: Multimodal intervention consisting of four core components · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Crohn's and Colitis CanadaOTHER
6 Previous Clinical Trials
1,242 Total Patients Enrolled
The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. FoundationUNKNOWN
The CH.I.L.D. Foundation - Children with Intestinal & Liver DisordersUNKNOWN
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
48 Previous Clinical Trials
63,273 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
642 Previous Clinical Trials
6,816,404 Total Patients Enrolled
Eric I Benchimol, MD, PhDPrincipal InvestigatorThe Hospital for Sick Children

Eligibility Criteria

Age 16 - 17 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to speak/read English at a functional (Grade 8) level.