D} National Institutes of Health. Science Behavior Change

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1 D} National Institutes of Health Science Of. Behavior Change

2 Webinar Moderator Anita McRae-Williams, MA Division of Extramural Research National Center for Complementary and Integrative Health

3 SOBC Speaker Jonathan W. King, PhD Division of Behavioral and Social Research National Institute on Aging

4 The Common Fund Transformative Cross-cutting Unique Synergistic Catalytic SOBC Vision: Infuse the study of mechanisms of behavior change across Institutes, behaviors, diseases, and translational stages on a large scale that lives on after the SOBC Common Fund.

5 Presentation Outline The SOBC Program The Experimental Medicine Approach PA Administrative Supplement Funding Opportunity Q&A

6 What is SOBC? Behavior change is hard but it can be done. We need to do identify what drives poor health behaviors and how to change those things. We need to know what works and what doesn t. We are developing transparent scientific methods that reveal how and why people change behavior. These blueprints will inform interventions to reliably improve health outcomes.

Intervention Development Pipelines Drugs and Devices Target ID Develop Assays Validate Targets Optimize Leads Pre - clinical Studies FDA IND/IDE Clinical trials I -III FDA Review Clinical trials IV

7 Intervention Development Pipelines Drugs and Devices Target ID Develop Assays Validate Targets Optimize Leads Pre - clinical Studies FDA IND/IDE Clinical trials I -III FDA Review Clinical trials IV Behavior Change Pre- SOBC 1 Diffuse Preclinical Activity Clinical trials Make it Cheaper Somehow SOBC 2 Post-SOBC (ICs) SOBC 2 (2015-) Identify and Isolate Targets Develop Assays Validate Targets Introduce Assays into Ongoing Studies Clinical trials

9 Experimental Medicine Approach What are the processes or mechanisms that drive behavior change? Answering this question requires: Hypotheses about targets (processes/mechanisms) that drive behavior Experimental methods for engaging the target Valid measures of target engagement

10 Behavior Change Target Domains Self- Regulation Behavior Change Interventions Stress Resilience and Stress Reactivity Interpersonal and Social Processes Changed Health Behaviors Smoking Eating Exercise Adherence

11 Self-Regulation Target Processes Self- Regulation Goal-Setting/ Planning Cognitive Control Emotion Regulation Self- Monitoring Attentional Control

13 Causal Mechanisms and Behavior Change Behavioral Assay Neuroimaging Assay Endocrine Assay Attentional Putative Target Control Gene Expression Attentional Intervention Bias Training Efficacious? Changed Behavior

Developing Attentional Assays and Verifying Target Engagement Amygdala

and increase attention to positive affective stimuli in the at risk

Successful training: 1) Decreases negative attention bias (left), and 2)

14 Developing Attentional Assays and Verifying Target Engagement Amygdala Attentional Bias Training is intended to decrease attention to negative and increase attention to positive affective stimuli in the at risk daughters of women with recurrent Major Depressive Disorder. Successful training: 1) Decreases negative attention bias (left), and 2) Is associated with decreased reactivity in the amygdala (right) during an Emotional Interference Task.

15 SOBC Speaker Will M. Aklin, PhD Division of Therapeutics and Medical Consequences National Institute on Drug Abuse

16 SOBC Funding Opportunity Use-inspired Basic Research to Optimize Behavior Change Interventions and Outcomes (PA ) Earliest submission: October 10, 2016 Application due date: November 10, 2016 Awards expected: Summer 2017

17 Purpose of FOA This funding opportunity announcement supports supplemental* research on target validation, assay development, and target engagement activities in one of the three SOBC-specified domains.

18 Behavior Change Target Domains Self- Regulation Behavior Change Interventions Stress Resilience and Stress Reactivity Interpersonal and Social Processes Changed Health Behaviors Smoking Eating Exercise Adherence

19 Example Supplement Activities Involve experimental manipulation of putative targets/mechanisms of action Add one or more measures/assays of a hypothesized target/mechanism

20 Example Supplement Activities (continued) Adapt an experimental manipulation of putative targets/mechanisms of action for a new health behavior or condition Develop or adapt measures/assays of a hypothesized target/mechanism for use in other settings

21 Eligible NIH Activity Codes P01 P20 P30 P50 RF1 R56 U54 UL1 R00 R01 R15 R21 R21/R33 R34 R37 U01 UH2 UH2/UH3

22 Application Details Parent award must be active* and the research proposed must be accomplished within the competitive segment Supplement application must be within the original scope* of the parent award

23 Application Details (continued) Research strategy is limited to 6 pages Discuss your application with your PO and one of the scientific contacts listed in the PA

24 Budget 1 year of funding only Budget should be commensurate with proposed activities

25 Budget (continued) Limited to no more than the amount of the parent award $2 million for supplements, pending availability of funds

26 Review of Applications Applications will be administratively reviewed by Program Officer of parent award SOBC Working Group members

27 Scientific Contacts Will M. Aklin, NIDA, Paige Green, NCI, Jonathan W. King, NIA, Melissa Riddle, NIDCR,

UH2/UH3 Target Validation Projects Pre-application Technical Assistance Webinar for: RFA-RM RFA-RM RFA-RM

UH2/UH3 Target Validation Projects Pre-application Technical Assistance Webinar for: RFA-RM-14-018 RFA-RM-14-019 RFA-RM-14-020 January 21, 2015 1:30 p.m. EST The NIH Science of Behavior Change Common Fund