Publication Date
1-1-2023
Journal
Contemporary Clinical Trials
DOI
10.1016/j.cct.2022.107017
PMID
36410689
PMCID
PMC9839528
PubMedCentral® Posted Date
1-1-2024
PubMedCentral® Full Text Version
Author MSS
Published Open-Access
yes
Keywords
Adolescent, Humans, Diabetes Mellitus, Type 1, Psychotherapy, Quality of Life, Randomized Controlled Trials as Topic, Self Report, Stress, Psychological, Multicenter Studies as Topic, Type 1 Diabetes, Adolescents, Psychosocial Outcomes, Resilience, Stress Managemen
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.
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.
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.
TRIAL REGISTRATION: Prospectively registered at Clinicaltrials.gov (NCT03847194)
Included in
Endocrine System Diseases Commons, Endocrinology, Diabetes, and Metabolism Commons, Mental and Social Health Commons, Neurosciences Commons, Pediatrics Commons, Psychiatry and Psychology Commons