Project Options, a Practical Clinical Trial

Project Options is an NIAAA-funded multisite randomized controlled trial being conducted in Miami, Florida, Minneapolis, Minnesota, and Portland, Oregon.  The project is examining the effectiveness of a voluntary school-based developmentally congruent, underage drinking prevention program offered in a drop-in group format during lunch.  Project Options is a Practical Clinical Trial; it involves an evidence-based reproducible (i.e., standardized) intervention across a range of settings, providers, and student participants. 

The underlying  theoretical model incorporates well established risk and resilience factors, and as such, Project Options is designed to be a real-world evaluation in regard to reach and effectiveness (see Schillinger, 2010).  Project Options also represents a blending of the efficacy and effectiveness stages of intervention development (see Curren et al., 2012); this type of hybrid design holds potential for improving the speed of knowledge creation and the usefulness and relevance of clinical research.  Effectiveness, as we are assessing Project Options, is the ability to do more good than harm for our target population, teenagers enrolled in high schools, across diverse, real-world settings.

Specifically, we are conducting a Efficacy-Effectiveness Hybrid Type 1 RCT. Hybrid 1 designs are appropriate under the following conditions: (1) strong face validity for the program supporting its applicability to the new setting, population, or delivery method in question; (2) a strong base of at least indirect evidence (e.g., data from different but associated populations) supporting applicability to the new setting, population, or delivery method in question; and (3) minimal risk associated with the program. Potential implementation research questions addressed in a Hybrid Type 1 RCT include: What are potential barriers and facilitators to “real-world” implementation of the intervention? What challenges were associated with delivering the intervention during the clinical effectiveness trial and how might they translate or not to real-world implementation? What potential modifications to the clinical intervention could be made to maximize implementation? What potential implementation strategies appear promising?

This paper will discuss how important parameters relevant to a Practical Clinical Trial are addressed within Project Options. These include: Adaptations across settings: e.g., recruitment strategies, recording/not-recording, length of intervention sessions, language, recruitment methods; Fidelity: e.g., change statements as per MI ratings; health educator manuals, with content equivalence and systematic differences in motivational engagement strategies and style.