Table 2 Changes in study design
| Original study design | Challenge identified | Final study design |
|---|---|---|
| All data collected in homes |
Some of the families identified as high-risk and most in need of the intervention were uncomfortable with letting someone into their home. Some clinics/WIC centers did not have sufficient space for data collection at the site. | Data collection in the home is still the primary goal, but we now also allow data collection to occur in the clinic/WIC centers or in another location (e.g., relative’s house). |
|
Factorial design that included the following groups: - CHW in clinic only - CHW in WIC only - CHW in home only - CHW in clinic and home - CHW in WIC and home - No CHW |
Families were less trusting of a CHW intervention that is not associated with a clinic or WIC center. Clinics and WIC centers expect CHWs to be flexible and meet families in settings outside of the clinic/WIC center | We simplified the design to a two-arm cluster randomized trial with wait-list control. One arm gets a CHW assigned to the clinic/WIC center, and the other receives CHW services when the study is over. CHWs work in the clinic/WIC and in homes, as preferred by families. |
| Oral health topics for CHW intervention chosen by investigators. | The specific needs of families did not align exactly with the topics chosen. | Oral health topics for CHW intervention were tailored to fit the specific needs of the families. |