The Promoting Resilience in Stress Management (PRISM) Intervention: a multisite randomized control trial in adolescents with Type 1 Diabetes

项目总结 患有1型糖尿病(T1D)的青少年患糖尿病痛苦升高的风险很高，这对 他们的依从性、血糖控制(A1C)和总体生活质量(QOL)。改善这些问题的一个潜在障碍 经验可能是，青少年几乎没有机会发展所需的个人资源 应对逆境，管理压力。“促进压力管理中的韧性”(PRISM)干预 是以技能为基础的手动简短干预，在2个45-60分钟的一对一会议中提供，然后 家庭会议，并辅之以助推器会议和数字应用程序。棱镜是从应力发展而来的 以及应对理论和目标技能--压力管理和正念、目标设定、积极重组、 和意义的创造。所有这些技能都与改善不同人群的患者预后有关 患有慢性/严重疾病的青少年人群以及对患有T1D的青少年进行可行性试验的结果 表明PRISM在这一人群中是高度可行和可取的。此外，最近的一项试点随机 对青少年癌症患者的对照试验表明，PRISM与改善对 韧性、较低的心理痛苦和较高的生活质量。此应用程序建议在以前的基础上构建 体验并填补三个关键知识空白：(1)PRISM对患有T1D的青少年A1C的影响；(2) PRISM对糖尿病痛苦、自我报告的依从性和其他患者报告的结果的影响，包括 复原力与生活质量；以及(3)PRISM与常规护理的成本效益比较。 经济分析。这一资助机会寻求测试针对糖尿病痛苦的干预措施的影响 在血糖控制方面。因此，我们建议在N=120名青少年中进行一项多点随机对照试验 60例PRISM，60例普通护理，年龄13-18岁，血糖控制6个月后的初步试验结果 招生。参与者将在连续的血糖监测仪上进行范围内时间的评估，作为一种探索 瞄准。次要结果将包括糖尿病痛苦，以及患者报告的依从性、弹性和 生活质量。还将对成本效益进行评估，以解决可持续性和 传播。我们假设PRISM将促进更好的血糖控制，改善糖尿病痛苦，以及 比平时的护理更具成本效益。该应用程序提供了一个扩展知识体系的机会 关于对患有T1D的青少年进行严格的循证干预。最终， 这项研究有可能提供实用的、以技能为基础的课程，旨在改善以下方面的结果 这个高危人群。

PROJECT SUMMARY 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; (2) PRISM’s impact on diabetes distress, self-reported adherence, and other patient-reported outcomes including resilience and QOL; and (3) the cost-effectiveness of PRISM compared to usual care in a prospective economic analysis. This funding opportunity seeks to test interventions targeting diabetes distress for impact on glycemic control. Thus, we propose a multi-site randomized controlled trial among N=120 adolescents (n=60 PRISM, n=60 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. Cost-effectiveness will also be assessed to address the potential for sustainability and dissemination. We hypothesize PRISM will promote better glycemic control, improved diabetes distress, and be more cost-effective 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.