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

在儿科医疗保健中，不坚持用药是可避免的痛苦和死亡的重要驱动因素。 超过一半的儿童不遵守处方药，不遵守是导致儿童死亡的主要原因。 儿科治疗失败不依从可能导致病情恶化、死亡、可预防的住院治疗， 增加的医疗费用和发病率。即使在儿童癌症中，当不依从的后果 化疗可能危及生命，超过40%的患者具有临床显著的不依从性。 对于最常见的儿科癌症，急性淋巴细胞白血病（ALL），只有10%的儿童错过了 化疗剂量有近4倍的癌症复发风险。尽管经过几十年的研究， 有效的策略，有意义地增加儿科药物的依从性。建议的目标 研究是通过测试一种新的目标--行为， 养育技巧-作为一种可改变的机制，以提高幼儿（3-9岁）的药物依从性。 根据我们的初步数据，我们已经开始开发CareMeds，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阶段模型的第0和第1阶段来进一步开发和 评估CareMeds干预的可行性。证据集中在家庭功能和 父母教养方式是影响儿童药物依从性的关键因素。然而，以前的研究通常依赖于 一次性的全球性措施，使得人们很难辨别出改善药物治疗的精确育儿技巧， 坚持。例如，我们对“支持性”或“凝聚力”的家庭到底在做什么知之甚少。 促进服药依从性。在目标1中，我们将在家中直接观察药物给药， 了解常见的情节级别的障碍，并确定最成功的行为育儿技巧 在幼儿中实现药物管理。在目标2中，我们将使用每日日志数据收集， 研究日常育儿经验如何影响药物不依从性的风险。我们将使用数据 从目标1和2和输入不同的父母，以完善最终的护理干预包。在目标3 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RCT 在开始口服化疗处方后1个月内患有ALL。这个研究项目的发现 将通过提供对以下方面的细致入微的理解， 在事件和日常水平的养育，塑造幼儿的药物依从性。它会让 通过使用直接观察给药、每日日记 短暂的育儿经历的数据，以及通过客观行为的严格测量坚持 测量（电子药瓶监测）和药理学测量（药物的有效生物标志物 代谢物）。最后，它将通过为全面的、多层次的 中心，RCT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.