Authors
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Yi-Frazier JP, Hilliard ME, O'Donnell MB, Zhou C, Ellisor BM, Garcia Perez S, Duran B, Rojas Y, Malik FS, DeSalvo DJ, Pihoker C, Bradford MC, Scott S, Devaraj S, Rosenberg AR -More
Category
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Primary study
Journal»JAMA NETWORK OPEN
Year
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2024
Importance Type 1 diabetes (T1D) requires demanding self-management health behaviors, and adolescents with T1D are at risk for poor psychosocial and medical outcomes. Developing resilience skills may help adolescents with T1D and elevated distress navigate common stressors and achieve positive outcomes. Objective To test the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention on levels of hemoglobin A(1c) (HbA(1c)), diabetes distress, self-management behaviors, resilience, and quality of life among adolescents. Design, Setting, and Participants This phase 3, parallel, 1:1 randomized clinical trial that followed up 172 participants for 12 months was conducted from January 1, 2020, to November 30, 2022, at each of 2 children's hospitals, in Seattle, Washington, and Houston, Texas. Participants were ages 13 to 18 years with T1D for at least 12 months and elevated diabetes distress. Intervention PRISM, a manualized, skills-based, individual intervention program that teaches stress management, goal setting, reframing, and meaning-making, facilitated by a coach and accompanied by a digital app, was delivered in three 30- to 60-minute sessions approximately 2 weeks apart. Main Outcomes and Measures The 2 primary outcomes, diabetes distress and HbA(1c) levels, and 3 secondary outcomes, resilience, quality of life, and engagement in self-management behaviors, were assessed at baseline and 6 and 12 months after baseline. Linear mixed-effects regression models were used to evaluate associations between PRISM or usual care (UC) and these outcomes at both time points for the intention-to-treat population. Results Among 172 adolescents (mean [SD] age, 15.7 [1.6] years), 96 were female (56%), and their baseline mean (SD) HbA(1c) level was 8.7% (2.0%). No differences were evident between PRISM and UC recipients in HbA(1c) levels (beta, -0.21 [95% CI, -0.65 to 0.22]; P = .33) or diabetes distress (beta, -2.71 [95% CI, -6.31 to 0.90]; P = .14) or any participant-reported outcome (eg, beta, 2.25 [95% CI, -0.30 to 4.80]; P = .08 for self-management behaviors) at 6 months. At 12 months, there was no statistically significant difference between arms in HbA(1c) levels (beta, -0.26 [95% CI, -0.72 to 0.19]; P = .25); however, PRISM recipients reported significantly greater amelioration of diabetes distress (beta, -4.59 [95% CI, -8.25 to -0.94]; P = .01) and improvement in self-management behaviors (beta, 3.4 [95% CI, 0.9 to 5.9]; P = .01) compared with UC recipients. Conclusions and Relevance The findings in this randomized clinical trial of psychosocial and behavioral improvements associated with PRISM at 12 months illustrate the value of a strengths-based intervention. Integrating resilience skills-building with traditional diabetes care may be a promising approach for improving outcomes among adolescents with T1D and elevated diabetes distress.
Epistemonikos ID: 2480b89f873221556672fb7d4268e8b990cf8998
First added on: Aug 20, 2024