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 患有1型糖尿病（T1D）的青少年患糖尿病困扰的高风险，这极大地影响 他们的依从性，血糖控制（A1C）和整体生活质量（QOL）。改善这些的潜在障碍 经验可能是青少年很少有机会开发所需的个人资源 处理广告并管理压力。 “促进压力管理中的韧性”（PRISM）干预 是一项手动，简短的，基于技能的干预措施，在2，45-60分钟内进行一对一的会议，其次是 家庭会议，并由助推器会议和数字应用程序补充。棱镜是由压力发展而来的 以及应对理论并针对压力管理和正念，目标设定，积极重塑的技能， 和意义的创造。所有这些技能都与在潜水员组的患者成果改善有关 患有慢性/严重疾病的青春期人群，以及T1D青少年可行性试验的发现 在这个人群中表明棱镜是高度可行和可取的。此外，最近的飞行员随机分组 癌症青少年的对照试验表明，棱镜与对 韧性，较低的心理困扰和更高的生活质量。本申请提案以我们的先验为基础 经验并填补三个关键知识空白：（1）Prism对T1D青少年对A1C的影响； （2） Prism对糖尿病困扰，自我报告的依从性以及其他患者报告的结果的影响 弹性和质量； （3）与预期的通常护理相比，Prism的成本效益 经济分析。这个资金机会旨在测试针对糖尿病困扰影响的干预措施 关于血糖控制。这，我们提出了n = 120名青少年的多站点随机对照试验 （n = 60棱镜，n = 60通常的护理； 13-18岁），在6个月后6个月的血糖对照的主要试验结果 注册。将评估连续葡萄糖监测仪的参与者作为探索性的时间范围 目的。次要结果将包括糖尿病患者以及患者报告的依从性，弹性和 生活质量。还将评估成本效益，以解决可持续性的潜力 传播。我们假设棱镜将促进更好的血糖控制，改善糖尿病的困扰以及 比平时更具成本效益。该应用程序提供了扩展知识体系的机会 最终，对T1D的青少年进行了严格且基于证据的干预措施。 这项研究有可能提供一种实用的，基于技能的课程，旨在改善结果 这个高风险群体。