PROJECT SUMMARY
This advanced-level short course will provide intensive training in innovative approaches for designing and
conducting randomized clinical trials (RCTs) of behavioral interventions. Currently there is insufficient evidence
from behavioral RCTs to inform public health campaigns, clinical guidelines, and insurance coverage for
behavioral interventions. A stronger evidence base will emerge from more rigorous and definitive efficacy and
effectiveness trials. In the field of behavioral medicine, the intervention development process is not
standardized or accepted as it is for pharmacotherapy and devices. Investigators require didactic training not
often included in medical and graduate programs, as well as mentorship, to implement best practices for RCT
design and conduct. Greater reliance on interdisciplinary team science and translational research models, and
wider adoption of advanced methodologies, will increase the impact of behavioral intervention research. This
course is designed for early- to mid-career scientists who are already planning or conducting a behavioral RCT
or who are conducting early-stage intervention development research that is expected to lead to an RCT. It is
designed to provide a longitudinal learning experience during which learners (hereafter “fellows”) acquire
foundational knowledge and apply it to a planned RCT. This hybrid course includes a four-day, in-person
meeting at which foundational concepts will be discussed, and five learning communities comprising two
faculty members and six fellows will be formed. Each learning community will engage in nine monthly, two-hour
video conference calls. Prior to each call, fellows will watch videos or listen to podcasts about selected RCT
topics. The program will employ a facilitated peer mentoring model in which two experienced faculty members
will work with six fellows, who in turn serve as peer mentors. During the virtual meetings, they will discuss how
to apply the didactic content to their planned RCTs. The core faculty members are leading experts in various
behavioral intervention research methodologies and have real-world experience conducting behavioral RCTs.
Adjunct faculty members and guest speakers will include rising stars who are developing cutting-edge RCT
methodologies and staff from funding agencies and payers. Course content will be organized by the NIH Stage
Model for Behavioral Interventions and focus on Stages II (efficacy) through V (dissemination and
implementation) to complement existing R25 offerings. In short, this course will train the next generation of
scientists to design and conduct programmatic, strategically-focused, interdisciplinary behavioral RCTs. In so
doing, we will contribute the rigorous evidence needed to change clinical guidelines, practices, and policies.