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Protocol for the Promoting Resilience in Stress Management (PRISM) intervention: A multi-site randomized controlled trial for adolescents with type 1 diabetes.

Authors :
O'Donnell MB
Scott SR
Ellisor BM
Cao VT
Zhou C
Bradford MC
Pihoker C
DeSalvo DJ
Malik FS
Hilliard ME
Rosenberg AR
Yi-Frazier JP
Source :
Contemporary clinical trials [Contemp Clin Trials] 2023 Jan; Vol. 124, pp. 107017. Date of Electronic Publication: 2022 Nov 21.
Publication Year :
2023

Abstract

Background: Adolescents with type 1 diabetes (T1D) are at high risk for elevated diabetes distress, which greatly impacts diabetes management, glycemic outcomes and overall quality of life. Developing protective skills and "resilience resources" to navigate adversity and manage diabetes distress has high potential to help adolescents with T1D achieve optimal behavioral, psychological, and health outcomes. The "Promoting Resilience in Stress Management" (PRISM) program is a manualized, brief, skills-based intervention delivered over 6 months via two 45-60 min one-on-one sessions and a family meeting with a PRISM coach, and supplemented by booster calls and a digital app. This trial (PRISM versus usual care)is designed to:: (1) assess PRISM's impact on glycemic outcomes and diabetes distress among adolescents with T1D, and (2) explor PRISM's impact on resilience, self-reported adherence, and quality of life.<br />Methods: We describe the protocol for a multi-site randomized controlled trial designed for adolescents ages 13-18 with elevated diabetes distress. The primary trial outcomes are glycemic outcomes and diabetes distress 6 months post-randomization. Secondary outcomes include resilience, self-reported adherence, and QOL 6 months post-randomization. Our hypothesis is that youth in the PRISM group will demonstrate better glycemic outcomes and improved diabetes distress, adherence, resilience, and QOL compared to usual care.<br />Conclusions: This study will provide methodologically rigorous data and evidence regarding a novel intervention to promote resilience among adolescents with T1D and elevated diabetes distress. This research has the potential to offer a practical, skills-based curriculum designed to improve outcomes for this high-risk group.<br />Trial Registration: Prospectively registered at Clinicaltrials.gov (NCT03847194).<br />Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Daniel DeSalvo has served as independent consultant for Dexcom and his institution has received research support from Insulet outside of the submitted work. The remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br /> (Copyright © 2022 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1559-2030
Volume :
124
Database :
MEDLINE
Journal :
Contemporary clinical trials
Publication Type :
Academic Journal
Accession number :
36410689
Full Text :
https://doi.org/10.1016/j.cct.2022.107017