Longitudinal test of adherence & control in kids new to T1 diabetes & 5-9 yrs old

描述(由申请人提供)：5-9岁和新诊断为1型糖尿病(T1 DM)的儿童终生罹患终末期肾病的风险增加，血糖控制不良可能会加剧这种风险。我们的试验数据表明，在刚接触T1 DM的5-9岁儿童中，高达44%的人在疾病早期就经历了血糖控制下降的情况，尽管随着他们离开蜜月期，治疗力度越来越大。此外，从文献中我们可以确定，这些下降可能不仅仅是由于C肽产生的损失，而且可能是不遵守T1 DM日常管理的结果。有针对性的行为干预可以帮助患者实现更好的依从性和血糖控制。不幸的是，不存在针对5-9岁儿童家庭的干预措施，也缺乏基础性研究来为这些家庭制定干预措施提供信息。PI是研究儿童T1 DM管理的领先者。随着修订后的R01，她现在寻求扩大她的研究，专注于儿童中期的干预发展。新的R01旨在1)前瞻性地确定5-9岁新发T1 DM儿童家庭的依从性和血糖轨迹；2)确定可改变的父母、孩子和家庭行为因素，作为这些家庭最佳依从性和血糖轨迹的障碍或促进者；3)开发专门针对这些家庭的原型预防干预。修订后的R01目标将通过两项研究来实现。在研究1中，120个家庭将完成一项为期30个月的前瞻性、纵向研究，研究新接触T1 DM的5-9岁儿童的依从性和血糖变化轨迹及其原因和后果。在研究2中，28名家长将参加旨在收集新数据的系列半结构化访谈，以了解我们预防性干预的内容，并审查和改进每个干预模块，以确保家庭之间的高水平接受性和参与度。最后，12个家庭将参与干预的试点可行性研究。R01具有重要意义，因为我们预计它将产生必要的数据，为特定和有针对性的行为干预的发展提供信息，最终可能导致新发T1 DM患者5-9岁儿童血糖控制和依从性的改善。它是创新的，因为它提出了一种混合方法研究设计，以有效地为我们的干预提供信息，并增加我们的治疗针对5-9岁T1 DM儿童的独特特征、需求和行为模式的可能性。我们还相信，它的计划是创新的，招募同质(按年龄)儿童样本和研究1‘S前瞻性纵向设计，这两个设计都代表了对新发T1 DM青年的现有研究的背离。研究团队在治疗开发、纵向研究、健康行为理论和T1 DM管理方面拥有互补的专业知识。预期的结果是相关的、基于经验的预防性治疗，确定值得信赖的注意力控制治疗，以及关于5-9岁新发T1糖尿病儿童健康结果的新的纵向数据。

DESCRIPTION (provided by applicant): Children 5-9 years-old and newly diagnosed with type 1 diabetes mellitus (T1DM) have an increased lifetime risk of developing end stage renal disease and poor glycemic control may exacerbate this risk. Our pilot data suggest that up to 44% of 5-9 year-olds new to T1DM experience declining glycemic control early in their disease despite increasing treatment intensification as they exit the honeymoon period. Moreover, from the literature, we can ascertain that these declines may not be solely due to a loss in C peptide production and may be an outcome of nonadherence to daily T1DM management. Targeted behavioral interventions can help patients to achieve better adherence and glycemic control. Unfortunately, no such interventions exist for families of 5-9 year-olds and there is a lack of foundational research to inform intervention development for these families. The PI is a leader in studying T1DM management in young children. With the revised R01, she now seeks to expand her research to focus on intervention development for children in middle childhood. The new R01 aims are to 1) prospectively identify adherence and glycemic trajectories in families of 5-9 year-olds old with new-onset T1DM; 2) identify modifiable parent, child, and family behavior factors that serve as barriers or facilitators of optimal adherence and glycemic trajectories in these families; 3) develop a prototype preventative intervention specifically tailored to these families. The revised R01 aims will be accomplished in two studies. In Study 1, 120 families will complete a 30-month prospective, longitudinal study of adherence and glycemic trajectories and the causes and consequences of these in 5-9 year-olds new to T1DM. In Study 2, 28 parents will participate in serial semi-structured interviews designed to gather new data to inform the content of our preventative intervention and review and refine each intervention module to ensure a high level of acceptability and engagement among families. Finally, 12 families will participate in a pilot feasibility study of the intervention. This R01 is significant because we expect it to produce the necessary data to inform the development of a specific and targeted behavioral intervention which may ultimately result in improved trajectories of glycemic control and adherence for 5-9 year-olds with new-onset T1DM. It is innovative because it proposes a mixed methods research design to efficiently inform our interventions and increase the likelihood our treatments will be targeted to the unique characteristics, needs, and behavioral patterns of 5-9 year-olds with T1DM. We also believe it is innovative in its plan to recruit a homogeneous (by age) sample of children and Study 1's prospective, longitudinal design, which both represent departures from existing research in youths with new-onset T1DM. The research team has complementary expertise in treatment development, longitudinal research, health behavior theories, and T1DM management. The expected outcomes are a relevant and empirically-based preventative treatment, identification of a creditable attention control treatment, and novel longitudinal data regarding health outcomes for 5-9 year-olds with new-onset T1DM.