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

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.