First STEPS- Study of Type 1 in Early Childhood and Parenting Support
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Primary caregivers for children ages 1-6 newly diagnosed with T1D
- Although we anticipate that the majority (90%) of primary caregivers will be female (e.g., mothers, grandmothers), we will include males who self-identify as the primary caregiver (e.g., fathers).
- Parents of children following all types of medical regimens, with any level of glycemic control, will be invited to participate.
- Parents must be able to adequately understand, speak, and read English to benefit from participation. Parents must have ready and consistent access to a mobile telephone with text messaging capability to participate.
Exclusion Criteria:
- Parent non-english speaking.
- Parents are the focus of this investigation and, therefore, cannot have serious mental illness (e.g., schizophrenia) or developmental disability that would limit participation. Similarly, children with T1D should not have other life-threatening disease (e.g., cancer, cystic fibrosis) or developmental disability (e.g., autism, mental retardation).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Stepped Care
Usual Care
150 subjects will be randomized to the stepped care intervention. All 150 participants will be assigned a parent coach after randomization to stepped care condition. At the child's next follow up clinic visit participants who have elevated depression scores OR who's child has not met A1c target will move on to Step 2 of the intervention- 5 sessions with a study interventionist. At the following child's clinic visit, participants can either remain in Step 1, move to Step 2, or if needed, move on to Step 3- using a continuous glucose monitor for 1 week followed by a meeting with a certified diabetes educator and a diabetes team clinical psychologist.
Participants randomized to usual care will participate in regular diabetes clinic visits and diabetes education, as they would have done without participation in this study.