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Innovative approaches to randomized behavioral clinical trials

Award Number: R25CA287902
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/15/2024
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Innovative approaches to randomized behavioral clinical trials - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $207,111 )
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Trans-NIH Research Support	000	3	2/26/2026	NON-COMPETING CONTINUATION	$207,111
														Subtotal = $207,111

Issue Date FY: 2025 ( Subtotal = $191,260 )
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Trans-NIH Research Support	001	2	4/29/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$191,260
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Trans-NIH Research Support	003	2	8/13/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2024	UNIVERSITY OF WISCONSIN SYSTEM	21 N PARK ST STE 6301	MADISON	WI	53715	DANE	USA	Trans-NIH Research Support	000	1	4/29/2025	NEW	$0
2025	2024	UNIVERSITY OF WISCONSIN SYSTEM	21 N PARK ST STE 6301	MADISON	WI	53715	DANE	USA	Trans-NIH Research Support	002	1	5/22/2025	NEW	$0
														Subtotal = $191,260

Issue Date FY: 2024 ( Subtotal = $215,595 )
2024	2024	UNIVERSITY OF WISCONSIN SYSTEM	21 N PARK ST STE 6301	MADISON	WI	53715	DANE	USA	Trans-NIH Research Support	000	1	1/23/2024	NEW	$215,595
														Subtotal = $215,595

Grand Total All Awards = $613,966

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Innovative approaches to randomized behavioral clinical trials

Award Number: R25CA287902

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/15/2024

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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