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

促进压力管理复原力 (PRISM) 干预：针对 1 型糖尿病青少年的多中心随机对照试验

• 批准号: 10381646
• 负责人: Joyce P Yi-Frazier
• 金额: $ 54.24万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10381646
• 关键词: Address; Adherence; Adolescent; Age; Area; Blood Glucose; Caregivers; Caring; Childhood; Chronic; Clinical; Cystic Fibrosis; Development; Diabetes Mellitus; Distress; Economics; Educational Curriculum; End stage renal failure; Enrollment; Evidence based intervention; Face; Family; Funding Opportunities; Goals; Health; Healthcare; Insulin-Dependent Diabetes Mellitus; International; Intervention; Knowledge; Life; Malignant Neoplasms; Measures; Mental disorders; Methodology; Outcome; Participant; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Perception; Population; Positioning Attribute; Psychosocial Assessment and Care; Quality of life; Randomized Controlled Trials; Reporting; Research; Resources; Risk; Self Management; Site; Stress and Coping; Testing; Time; Training; Training Programs; Vulnerable Populations; Work; Youth; adolescent health; adolescent health outcomes; base; comparison intervention; cost; cost effective; cost effectiveness; craniofacial disorder; design; diabetes distress; diabetes management; digital; economic evaluation; efficacy evaluation; experience; feasibility trial; glucose monitor; glycemic control; high risk; high risk population; improved; improved outcome; innovation; meetings; mindfulness; models and simulation; multidisciplinary; novel; person centered; post intervention; prevent; primary outcome; programs; prospective; psychological distress; psychosocial; resilience; secondary analysis; secondary outcome; skills; stress management; stressor; theories; therapy design; treatment as usual; trial comparing; trial design

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.

项目摘要 青少年1型糖尿病（T1 D）是糖尿病痛苦增加的高风险，这极大地影响了他们的健康。 他们的依从性、血糖控制（A1 C）和总体生活质量（QOL）。一个潜在的障碍，以改善这些 经验可能是，青少年很少有机会发展个人资源， 处理逆境和管理压力。“促进压力管理中的复原力”干预措施 是一个手动的，简短的，以技能为基础的干预，在2，45-60分钟的一对一的会议，然后 一个家庭会议，并辅以助推器会议和一个数字应用程序。PRISM是从压力开发的 和应对理论和目标技能的压力管理和正念，目标设定，积极的重构， 和创造意义所有这些技能都与改善不同人群的患者结局相关。 患有慢性/严重疾病的青少年人群，以及T1 D青少年可行性试验的结果 表明PRISM在该人群中是高度可行和可取的。此外，最近的一个试点随机 在青少年癌症患者中进行的对照试验表明，PRISM与改善对 恢复力、较低的心理困扰和较高的生活质量。该应用程序建议建立在我们先前的 体验并填补三个关键的知识空白：（1）PRISM对T1 D青少年A1 C的影响;（2） PRISM对糖尿病困扰、自我报告依从性和其他患者报告结局的影响，包括 弹性和生活质量;（3）PRISM的成本效益相比，在一个前瞻性的常规护理 经济分析。这个资助机会旨在测试针对糖尿病困扰的干预措施的影响 血糖控制因此，我们建议在N=120名青少年中进行多中心随机对照试验 （n=60例PRISM，n=60例患者护理;年龄13-18岁），主要试验结局为术后6个月血糖控制 招生作为探索性研究，将对接受动态血糖监测的受试者评价范围内时间 瞄准次要结局将包括糖尿病困扰和患者报告的依从性，弹性， 生活质量还将评估成本效益，以探讨可持续性的潜力， 传播。我们假设PRISM将促进更好的血糖控制，改善糖尿病痛苦， 比一般的护理更具成本效益。这个应用程序提供了一个机会，以扩大知识体系 关于对T1 D青少年进行严格的方法学和循证干预。最后， 这项研究有可能提供一个实用的，以技能为基础的课程，旨在改善结果， 这个高危人群。