Remedy to Diabetes Distress (R2D2): Development protocol for a scalable screen-to-treat program for families of school-age children

Background: School-age children with type 1 diabetes (T1D) need help from parents or other adult caregivers (caregivers) to effectively manage T1D, resulting in greater vulnerability to Diabetes Distress (DD) for both children and caregivers. Unfortunately, there are no scalable screen-to-treat programs for clinics to adopt to identify and treat DD in school-age families.Methods and analyses: We aim to design a scalable, clinic-based screen-to-treat program for DD in families of school-age children and to test whether our new program to reduce caregiver and child DD also reduces child glycemic levels. Our Remedy to Diabetes Distress (R2D2) program will target caregivers and children with T1D who are between 8 and 12 years old. It will merge routine and automated surveillance of DD in the clinical setting with at home digital delivery of a theory-based behavioral and psychological treatment of DD. We will use the ORBIT Model for Behavioral Intervention development to guide four small and cost-effective formative studies to develop our R2D2 program and assess initial treatment effects. In tandem, we will implement clinic-based DD screening in school-age families and assess feasibility and acceptability of our screening platform as a Quality Improvement activity. The study started in September 2020 and is scheduled to conclude in 2025.Conclusions: The study will use a single Institutional Review Board (IRB) with Children's Mercy-Kansas City operating as the IRB of record. We will disseminate study results through presentations at scientific conferences and through peer-reviewed journals read by the psychology and diabetes care communities.