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.
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