Phase I—Feasibility, Proof of Concept
Phase I typically involves one or more pilot-level studies to identify an appropriate theoretical base for an intervention (explored in Chapter 4), identifying and evaluating treatment components and determining their acceptability, feasibility, and safety. In this phase, a wide range of research design strategies can be used, such as case studies, pre-post study designs, focus groups, or a combination of them to define and refine the content of the intervention and derive delivery characteristics (dose, intensity, or treatment components—see Chapter 5 for a discussion
Figure 2.1 Traditional pipeline.
of delivery characteristics). The most common ones are listed in Table 2.1. Additionally, qualitative research and mixed methodologies that seek an integration of qualitative and quantitative strategies to derive comprehensive understandings of a phenomenon (see Chapter 11) can also be helpful in this phase to evaluate the acceptability and utility of intervention components and the potential barriers to adherence and behavioral change.