Rigor and equity in intervention study design in pediatric psychology: a focus on comparator conditions from diabetes research.

Objectives: To advance the science of health intervention research, pediatric psychologists must carefully design and conduct intervention research studies, including clinical trials. In contrast to guidance about scientific rigor in the selection of comparator groups in clinical trials, far less has been published on equity considerations in this process. The purpose of this paper is to review considerations for centering both equity and rigor in the study design decision, with a focus on the selection of comparator conditions for clinical trials of pediatric psychology interventions and propose potential solutions.

Methods: We reviewed existing guidance on (1) intervention study design with a focus on selection of comparator conditions from health psychology, medicine, and other similar fields, and (2) integration of both rigor and equity considerations into the design of intervention studies.

Results: We present a range of options for study design choices regarding comparator conditions and discuss potential benefits, limitations, and practical considerations for each type of comparator condition. Examples from behavioral intervention trials in pediatric type 1 diabetes or type 2 diabetes were used to illustrate how each comparator condition functions in practice. We developed a practical guide for researchers to consider both rigor and equity in decisions related to intervention study design and comparator condition selection.

Conclusions: The process of selecting an appropriate comparator condition is one aspect of study design that can advance both equity and scientific rigor in pediatric psychology intervention research.