Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence

在儿科保健中，不坚持服药是可避免的痛苦和死亡的一个重要驱动因素。 超过一半的儿童不坚持服用处方药，不坚持是导致 儿科治疗失败。不遵守规定可能会导致病情恶化、死亡、可预防的住院、 增加了医疗保健费用，并增加了发病率。即使在儿科癌症中，当不坚持的后果 对于可能危及生命的化疗，超过40%的患者在临床上存在严重的不依从性。 对于最常见的儿童癌症，急性淋巴细胞性白血病(ALL)，儿童仅错过10% 化疗剂量几乎是癌症复发风险的4倍。尽管有几十年的研究，但我们还没有 有意义地提高儿科用药依从性的有效策略。建议的目标是 研究旨在通过测试一种新的目标--行为来降低可预防的儿科发病率和死亡率 育儿技巧--作为改善幼儿(3-9岁)服药依从性的一种可修改机制。 基于我们的初步数据，我们已经开始开发CareMeds，这是一种以育儿技能为重点的坚持 干预。该项目的目标是使用NIH阶段模型的阶段0和阶段1来进一步开发和 评估CareMeds干预的可行性。关于家庭功能的证据越来越多 父母教养方式是影响儿童服药依从性的关键因素。然而，以前的研究通常依赖于 一次性的全球措施，使人们很难辨别出改善药物治疗的准确育儿技能 坚持不懈。例如，我们对“支持性”或“凝聚性”家庭到底在做些什么知之甚少 促进用药依从性。在目标1中，我们将使用在家中直接观察用药来 了解常见剧集级别的障碍，并确定最成功的行为育儿技巧 在实现幼儿用药方面的重要作用。在目标2中，我们将使用日常日记数据收集来 检查日常育儿经历如何影响药物不依从性的风险。我们将使用数据 来自目标1和目标2以及来自不同家长的意见，以完善最终的CareMeds干预方案。在AIM 3中 我们将对100个3-9岁幼儿家庭进行干预与常规护理的试点随机对照试验 均在口服化疗处方开始后1个月内完成。这个研究项目的发现 将通过提供对以下方面的细微差别的理解来做出重大的概念性贡献 在插曲和日常水平上的养育方式塑造了幼儿的服药依从性。它会让你 通过使用直接观察给药、每日日记的创新方法进步 关于短暂育儿经历的数据，以及通过客观行为严格衡量遵从性的数据 措施(电子药瓶监测)和药理措施(已确认的药物生物标志物 代谢物)。最后，它将通过为全面、多层次的 RCT中心检查CareMeds干预的有效性。

In pediatric health care non-adherence to medications is a significant driver of avoidable suffering and death. Over half of children do not adhere to prescribed medications, and non-adherence is the leading cause of treatment failure in pediatrics. Non-adherence can lead to worsening illness, death, preventable hospitalization, increased health care cost, and morbidity. Even in pediatric cancer, when the consequences of non-adherence to chemotherapy are potentially life threatening, over 40% of patients have clinically significant non-adherence. For the most common pediatric cancer, Acute Lymphoblastic Leukemia (ALL), children who miss just 10% of chemotherapy doses have a nearly 4-fold risk of cancer relapse. Despite decades of research we do not have effective strategies to meaningfully increase pediatric medication adherence. The goal of the proposed research is to reduce preventable pediatric morbidity and mortality through testing a novel target – behavioral parenting skills – as a modifiable mechanism to improve medication adherence in young children (ages 3-9). Based upon our preliminary data we have begun to develop CareMeds, a parenting skills-focused adherence intervention. The goal of this project is to use stages 0 and 1 of the NIH Stage Model to further develop and evaluate the feasibility of the CareMeds intervention. Evidence is converging on family functioning and parenting style as critical factors that shape child medication adherence. Yet, previous studies typically rely on one-time global measures, making it difficult to discern the precise parenting skills that improve medication adherence. For example, we know very little about what exactly “supportive” or “cohesive” families are doing to promote medication adherence. In Aim 1 we will use direct observation of medication administration at home to understand common episode-level barriers and identify the behavioral parenting skills that are most successful in achieving medication administration in young children. In Aim 2 we will use daily diary data collection to examine how daily parenting experiences influence the risk of medication non-adherence. We will use data from Aims 1 and 2 and input from diverse parents to refine the final CareMeds intervention package. In Aim 3 we will conduct a pilot RCT of the intervention versus usual care with 100 families of young children ages 3-9 with ALL within 1 month of initiation of oral chemotherapy prescription. Findings from this program of research will make significant conceptual contributions through providing nuanced understanding of the aspects of parenting at the episode and daily levels that shape medication adherence in young children. It will make innovative methodological advances through use of direct observation of medication administration, daily diary data on transient parenting experiences, and rigorous measurement of adherence through objective behavioral measures (electronic pill bottle monitoring) and pharmacological measures (validated biomarkers of drug metabolites). Finally, it will have significant translational impact through setting the stage for a full-scale, multi- center, RCT to examine the efficacy of the CareMeds intervention.