# Innovative Approaches to Randomized Behavioral Clinical Trials

> **NIH NIH R25** · WASHINGTON UNIVERSITY · 2020 · $216,000

## Abstract

PROJECT SUMMARY
This advanced short course will provide intensive training in innovative approaches to randomized behavioral
clinical trials. The long-term goal of the course is to increase the clinical impact and public health significance
of health-related behavioral intervention research. It will achieve this goal by training the participants to a)
identify ways to maximize the impact of their research on clinical practice and prevention guidelines, health
care financing policies, and health care services; b) utilize advanced methodologies and interdisciplinary team
science to test the efficacy, effectiveness, and cost-effectiveness of health-related behavioral interventions;
and c) disseminate the course materials and use them to train other researchers in these advanced
approaches. A majority of the 36 participants each year (144 over four years) will be mid-career scientists but
the course will be open to all academic ranks and to a variety of health-related disciplines. The 12 core faculty
members are experts and experienced educators in various aspects of behavioral intervention research
methodology, clinical trial design and management, and biostatistical methods. They will be joined by two
adjunct faculty members and several guest speakers. The 8½ day course will feature lectures, panel
discussions, interdisciplinary team projects, and individual mentorship opportunities. The course will address a
different objective each day, and the daily objectives will follow a coherent sequence that corresponds to the
evolution of an innovative and strategically-focused behavioral intervention research program. The sequence
starts with the identification of long-term, strategic goals for health-related behavioral research, progresses
through Phases I and II, and ends with definitive Phase III trials and an introduction to Phase IV research. Day
1 will address reverse translation strategies and the key roles of health care gatekeepers and stakeholders in
the formulation of strategic research goals. Day 2 moves from goal-setting to determine which behavioral
factors and clinical outcomes to target in order to achieve the research program's goals. Day 3 covers the
translational research models and optimization frameworks that can be used to structure intervention research
programs and accelerate progress towards improved outcomes. It also covers approaches to building diverse,
inclusive, interdisciplinary research teams and multicenter networks. The first three days lay the groundwork
for the next five days of the course, during which a succession of advanced methodological topics in Phase I,
II, and III intervention research will be covered. The final day of the course will include a presentation of the
interdisciplinary team projects, discussion of participants' plans for dissemination of course materials, and
discussion of participants' plans for incorporating what they have learned in the course into their own research
programs. Multi-level evalua...

## Key facts

- **NIH application ID:** 9852174
- **Project number:** 1R25HL149668-01
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** KENNETH E FREEDLAND
- **Activity code:** R25 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $216,000
- **Award type:** 1
- **Project period:** 2020-01-01 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9852174

## Citation

> US National Institutes of Health, RePORTER application 9852174, Innovative Approaches to Randomized Behavioral Clinical Trials (1R25HL149668-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9852174. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
