Nemours Children's Health-Jacksonville, 807 Children's Way, Jacksonville, FL 32207, United States of America.
Nemours Children's Health-Florida, 6900 Lake Nona Blvd, Orlando, FL 32827, United States of America.
Contemp Clin Trials. 2022 Aug;119:106829. doi: 10.1016/j.cct.2022.106829. Epub 2022 Jun 15.
School-age children with type 1 diabetes (T1D) need help from parents or other adult caregivers (caregivers) to effectively manage T1D, resulting in greater vulnerability to Diabetes Distress (DD) for both children and caregivers. Unfortunately, there are no scalable screen-to-treat programs for clinics to adopt to identify and treat DD in school-age families.
We aim to design a scalable, clinic-based screen-to-treat program for DD in families of school-age children and to test whether our new program to reduce caregiver and child DD also reduces child glycemic levels. Our Remedy to Diabetes Distress (R2D2) program will target caregivers and children with T1D who are between 8 and 12 years old. It will merge routine and automated surveillance of DD in the clinical setting with at home digital delivery of a theory-based behavioral and psychological treatment of DD. We will use the ORBIT Model for Behavioral Intervention development to guide four small and cost-effective formative studies to develop our R2D2 program and assess initial treatment effects. In tandem, we will implement clinic-based DD screening in school-age families and assess feasibility and acceptability of our screening platform as a Quality Improvement activity. The study started in September 2020 and is scheduled to conclude in 2025.
The study will use a single Institutional Review Board (IRB) with Children's Mercy-Kansas City operating as the IRB of record. We will disseminate study results through presentations at scientific conferences and through peer-reviewed journals read by the psychology and diabetes care communities.
学龄期儿童 1 型糖尿病（T1D）需要父母或其他成年照顾者（照顾者）的帮助才能有效管理 T1D，这使得儿童和照顾者都更容易出现糖尿病困扰（DD）。不幸的是，诊所没有可扩展的筛查-治疗计划来识别和治疗学龄期家庭的 DD。
我们旨在为学龄期儿童家庭设计一个可扩展的、基于诊所的 DD 筛查-治疗计划，并测试我们的新方案是否可以减轻照顾者和儿童的 DD，同时降低儿童的血糖水平。我们的“缓解糖尿病困扰（R2D2）”计划将针对 8 至 12 岁患有 T1D 的照顾者和儿童。它将在临床环境中合并常规和自动化的 DD 监测，以及在家中通过基于理论的 DD 行为和心理治疗的数字交付。我们将使用 ORBIT 行为干预发展模型来指导四项小型且具有成本效益的形成性研究，以开发我们的 R2D2 计划并评估初始治疗效果。同时，我们将在学龄期家庭中开展基于诊所的 DD 筛查，并评估我们的筛查平台作为质量改进活动的可行性和可接受性。该研究于 2020 年 9 月开始，计划于 2025 年结束。
该研究将使用单一机构审查委员会（IRB），堪萨斯城儿童慈善会作为记录审查委员会。我们将通过科学会议的演讲和心理与糖尿病护理界阅读的同行评审期刊来传播研究结果。
