Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03847194 |
| Other study ID # |
SC-N130 |
| Secondary ID |
R01DK121224 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
March 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Seattle Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is well-known that adolescents with type 1 diabetes are at high risk for elevated
diabetes-specific distress and poor glycemic control. This randomized controlled trial uses a
novel, person-centered intervention designed to reduce diabetes distress and improve
resilience skills, which the investigators hypothesize will in turn improve glycemic control
and quality of life. If successful, results will greatly inform future research and clinical
strategies aimed at improving outcomes among adolescents with type 1 diabetes.
Description:
Adolescents with type 1 diabetes (T1D) are at high risk for elevated diabetes distress, which
greatly impacts their adherence, glycemic control (A1C), and overall quality of life (QOL). A
potential barrier to improving these experiences may be that adolescents have few
opportunities to develop the personal resources needed to handle adversity and manage stress.
The "Promoting Resilience in Stress Management" (PRISM) intervention is a manualized, brief,
skills-based intervention delivered in 2, 45-60 minute one-on-one sessions, followed by a
family meeting and supplemented by booster sessions and a digital app. PRISM was developed
from Stress and Coping theory and targets skills in stress-management and mindfulness,
goal-setting, positive reframing, and meaning-making. All of these skills are associated with
improved patient outcomes in diverse groups of adolescent populations with chronic/serious
illness, and findings from a feasibility trial in adolescents with T1D showed PRISM to be
highly feasible and desirable in this population. Further, a recent pilot randomized
controlled trial among adolescents with cancer suggest PRISM is associated with improved
perceptions of resilience, lower psychological distress, and higher QOL. This application
proposes to build on our prior experience and fill three critical knowledge gaps: (1) PRISM's
impact on A1C among adolescents with T1D; and (2) PRISM's impact on diabetes distress,
self-reported adherence, and other patient-reported outcomes including resilience and QOL.
This funding opportunity seeks to test interventions targeting diabetes distress for impact
on glycemic control. Thus, the investigators propose a multi-site randomized controlled trial
among N=160 adolescents (n=80 PRISM, n=80 Usual Care; ages 13-18) with the primary trial
outcome of glycemic control 6-months post-enrollment. Time-in-range will be evaluated for
participants on continuous glucose monitors as an exploratory aim. Secondary outcomes will
include diabetes-distress, and patient-reported adherence, resilience, and quality of life.
The investigators hypothesize PRISM will promote better glycemic control and improved
diabetes distress than usual care. This application offers an opportunity to expand the body
of knowledge regarding methodologically rigorous and evidence-based interventions for
adolescents with T1D. Ultimately, this research has the potential to offer a practical,
skills-based curriculum designed to improve outcomes for this high-risk group.
