Research Design and Methods Overview of Study Design \& Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a stepped care intervention that provides participants with up to 3 intensity levels, or steps, of clinical behavioral intervention support to help manage young children's newly diagnosed type 1 diabetes (T1D), compared to usual care. We expect that children of families allocated to the intervention condition (First STEPS) will have better glycemic outcomes, better parent psychosocial functioning, and fewer behavior problems, including negative mealtime behaviors. A total of 200 parents will be randomly allocated in a 3:1 ratio to be treated with either First STEPS (n=150) or usual care (n=50; COMPARISON condition): all participants receive standard diabetes education as part of usual care in both conditions. Our intervention is intended to be delivered by trained peer parent coaches (Step 1), bachelor's or master's prepared research educators (Step 2), and RN or master's level certified diabetes educators and PhD level clinical psychologist (Step 3).
For Step 1 we are employing the use of parent coaches as a low-cost highly translatable intervention that parents in our pilot study reported to be extremely helpful following the time of diagnosis. For Step 2 the research educators will build upon support provided by parent coaches, and will implement our 5 telephone session behavioral intervention that provides cognitive behavioral strategies to support parents in their daily management of T1D, while at the same time targets parental mood and specifically symptoms of depression. Step 3 engages certified diabetes educators and the diabetes team clinical psychologist and allows for more intensive review of the child's medical regimen and targets potential changes. The clinical psychologist consultation addresses how symptoms of parental depression may interfere with caring for the child's diabetes, and will refer for further treatment if needed. Intervention content, training, and fidelity for each intervention step are described below. Participants are evaluated at baseline (at diagnosis, pre-random allocation) and follow-up (3-, 6-, 9-, 12-, and 15-months post-diagnosis). These steps are sequentially designed to systematically build expertise and intensity.
Participants. 200 self-identified primary caregivers for children ages 1-6 newly diagnosed with T1D (50% female) will be enrolled at 2 trial sites in (1) Washington, DC (Children's National Medical Center; CNMC), and (2) Houston, Texas (Texas Children's Hospital; TCH). T1D affects approximately 1 in 500 children, and although its incidence is increasing, numbers of available children for study are still much lower than for other illnesses including type 2 diabetes. The investigators have therefore decided to have 2 sites for adequate power for this study. Although the investigators anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), males who self-identify as the primary caregiver (e.g., fathers) will also be included.
