ABSTRACT
Pediatric clinical trials are important for discovering effective medicines, treatments, devices, and
interventions designed for children and adolescents. However, recruitment and retention in pediatric clinical
trials remains a challenge. Enrollment in clinical trials requires both consent of the parent and assent of the
youth and the roles that each takes and the contributions that each makes in the decision-making process can
vary, especially across development. When children are younger, parents are more likely to decide whether or
not their child will participate in a clinical trial. As children mature, the decision-making process typically
shifts to become more collaborative between parents and adolescents. There is evidence that both parents and
adolescents prefer a shared decision-making (SDM) approach to clinical trial participation; however, there are
few studies that directly examine the parent-child communication behaviors that are a part of the decision-
making process. The proposed project will address this gap through the use of videotaped observations,
questionnaires, and semi-structured interviews. A diverse sample of parent-adolescent pairs (N=80) will be
observed making the decision whether to participate in two different types of hypothetical pediatric clinical
trials (i.e., high-risk; low-risk). Following each discussion, pairs will complete self-report questionnaires about
the experience. Positive (e.g., complimenting) and negative communication (e.g., sarcasm) behaviors will be
coded. Aim 1 will examine how positive and negative communication behaviors relate to parent and adolescent
decision-making involvement, communication satisfaction, and likelihood to participate in the trials. Given the
dyadic nature of the decision-making process, an Actor-Partner-Interdependence Model framework will be
applied to explore the unique and dyadic effects of parent-child communication on pediatric clinical trial
decision-making. In addition, a subgroup (N=20) of parent-teen pairs from the observational study will be
purposively sampled to participate in follow-up interviews. Adolescents’ report of communication satisfaction
will be used to identify pairs that experienced the most positive and negative decision-making experiences.
This approach will allow us to gather the most information-rich data from experiences on both sides of
spectrum. The proposed project will provide novel information about the specific communication behaviors
that parents and adolescents engage in as part of the decision-making process and how these behaviors impact
their final decisions and satisfaction with the process. The findings from this project have the potential to
inform the development of education resources or decision aids that can support families in engaging in more
effective shared decision-making practices with their developing adolescent when provided with the
opportunity to participate in a pediatric clinical trial.