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: 10502798
• 负责人: Joyce P Yi-Frazier
• 金额: $ 9.15万
• 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/10502798
• 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.

项目概要 患有 1 型糖尿病 (T1D) 的青少年患糖尿病困扰的风险很高，这极大地影响了他们的健康状况。 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，青少年很少有机会发展个人资源，以实现个人目标。 处理逆境并管理压力。 “促进压力管理复原力”（PRISM）干预 是一种手动、简短、基于技能的干预措施，通过 2 次 45-60 分钟的一对一课程进行，然后 家庭会议，并辅以加强会议和数字应用程序。 PRISM 是由 Stress 发展而来 应对理论和目标技能，包括压力管理和正念、目标设定、积极重构、 和意义创造。所有这些技能都与改善不同群体的患者预后相关 患有慢性/严重疾病的青少年人群，以及针对患有 T1D 的青少年进行的可行性试验的结果 表明 PRISM 在这一人群中是高度可行和理想的。此外，最近的一项试点随机 对患有癌症的青少年进行的对照试验表明，PRISM 与改善对癌症的认知有关 复原力、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之前的基础上 经验并填补三个关键知识空白：(1) PRISM 对 T1D 青少年 A1C 的影响； (2) PRISM 对糖尿病困扰、自我报告的依从性和其他患者报告的结果的影响，包括 复原力和生活质量； (3) 在前瞻性研究中 PRISM 与常规护理相比的成本效益 经济分析。该资助机会旨在测试针对糖尿病困扰的干预措施的影响 关于血糖控制。因此，我们建议在 N=120 名青少年中进行一项多中心随机对照试验 （n=60 PRISM，n=60 常规护理；年龄 13-18），主要试验结果是治疗后 6 个月的血糖控制 注册。作为探索性的研究，将在连续血糖监测仪上对参与者的时间范围进行评估 目的。次要结果将包括糖尿病困扰以及患者报告的依从性、恢复力和 生活质量。还将评估成本效益，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、改善糖尿病困扰，以及 比常规护理更具成本效益。该应用程序提供了扩展知识体系的机会 关于对患有 T1D 的青少年进行严格的方法和基于证据的干预措施。最终， 这项研究有潜力提供实用的、基于技能的课程，旨在改善结果 这个高危人群。

项目成果

Preventing, Screening, and Treating Suicidality in Pediatric Type 1 Diabetes: Roles for Behavioral Health Care Professionals.

预防、筛查和治疗儿童 1 型糖尿病的自杀行为：行为保健专业人员的角色。

• DOI: 10.2337/dci22-0008
• 发表时间: 2022
• 期刊: Diabetes care
• 影响因子: 16.2
• 作者: Jaser,SarahS;Hilliard,MarisaE
• 通讯作者: Hilliard,MarisaE