'Parent-Child Co-Regulation of Pediatric Diabetes'

描述（由申请人提供）：成功的糖尿病管理依赖于一个自我调节的过程，在这个过程中，治疗行为是由血糖（BG）水平变化和决策的反馈指导的。在成人1型糖尿病（T1DM）患者中，参与自我调节的过程已被广泛研究，导致复杂研究工具的发展，显著提高了我们对临床结果的理解和预测能力。此外，这项研究还开发了一种高效的、基于经验的心理行为干预方法——血糖意识训练（BGAT），由我们的研究团队开发，可改善成人T1DM患者的自我调节和临床结果。不幸的是，涉及儿童糖尿病自我调节的过程几乎没有得到实证关注。拟议项目的目的是通过调整成人研究中使用的概念和方法工具来纠正这一科学忽视：1)调查患有T1DM的学龄儿童（6-11岁）及其父母的糖尿病调节过程；2)开发和测试干预措施，以提高对这一过程至关重要的技能。这是一个重要的目标人群，因为：1)患有T1DM的儿童及其父母在症状和BG检测方面的准确性远远低于成年患者；2)作为一个群体，儿科患者更容易出现阴性临床后遗症（如严重低血糖（SH）和DKA）；3)早期干预可以通过更多地减少急性和长期并发症、医疗保健利用和残疾，从而获得更大的公共卫生保健效益。本项目的1A和1B期将首次对学龄T1DM儿童及其父母的症状识别、BG检测、决策及后续临床后遗症进行系统、全面的研究。提出并验证了儿童糖尿病共同调节的理论模型，其中父母和儿童的行为影响决定避免或发生负面结果（如极端低血糖和高血糖）的事件顺序。基于这些研究的结果和我们目前针对成人的BGAT，第一阶段C将试点测试为T1DM学龄儿童父母设计的干预措施的翻译，BGAT为父母（BGAT- p）。这种干预将利用父母作为儿童糖尿病管理的主要老师的关键作用，包括父母与孩子一起进行的培训活动，旨在提高儿童识别BG症状、发现BG极端情况并做出适当的自我治疗决定的能力。基于前期研究的结果和家长的反馈，BGAT-P将在二期临床对照试验中进一步完善和测试，以评估其短期疗效。第三阶段是一项为期12个月的随访研究，以确定第二阶段发现的改善是否随着时间的推移而保持，并评估BGAT-P对未来临床负面事件的影响，包括儿童经历SH和DKA的频率。

DESCRIPTION (provided by applicant): Successful diabetes management relies on a process of self-regulation in which treatment behavior is guided by feedback about changing blood glucose (BG) levels and decision-making. The processes involved in self-regulation have been studied extensively in adults with Type 1 Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that have significantly advanced our understanding and ability to predict clinical outcome. Additionally, this research has led to the development of a highly effective, empirically based, psychobehavioral intervention, Blood Glucose Awareness Training (BGAT), developed by our research team, that improves self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes involved in the self-regulation of pediatric diabetes have received virtually no empirical attention. The purpose of the proposed project is to correct this scientific neglect by adapting the conceptual and methodological tools used in adult studies to 1) investigate the process of diabetes regulation by school-aged children (6-11 yrs) with T1DM and their parents and 2) develop and test an intervention to enhance the skills critical to this process. This is an important population to target for this line of inquiry because: 1) children with T1DM and their parents appear to be far less accurate than adult patients in symptom and BG detection; 2) As a group, pediatric patients are more likely to suffer from negative clinical sequelae (e.g., severe hypoglycemia (SH) and DKA); and, 3) Early intervention could have greater public health care benefit by achieving more reductions in acute and long-term complications, health care utilization, and disability. Phases 1A and 1B of the proposed project will provide the first systematic and comprehensive study of symptom recognition, BG detection, decision-making, and subsequent clinical sequelae in school-aged children with T1DM and their parents. A theoretical model of co-regulation of pediatric diabetes is proposed and tested, in which the behaviors of both parent and child influence the sequence of events that determine avoidance or occurrence of negative outcomes, such as extreme hypo- and hyperglycemia. Based on the findings of these studies and our current BGAT for adults, Phase 1 C will pilot test a translation of this intervention designed for parents of school-aged children with T1DM, BGAT for parents (BGAT-P). This intervention will take advantage of the critical role parents play as the primary teachers of children about diabetes management by including training activities for parents to do with their children designed to improve children's ability to recognize BG symptoms, detect extremes in BG, and make appropriate self-treatment decisions. Based on the findings from this pilot study, and feedback from parents, in Phase 2 BGAT-P will be further refined and tested in a controlled clinical trial to assess its short-term efficacy. Phase 3 is a 12-month follow-up study to determine whether the improvements found in Phase 2 are maintained over time and also to assess the impact of BGAT-P on future clinical negative events, including frequency of SH and DKA experienced by children.