Health Behavior Theory at the NIDCR Melissa Riddle & Dave Clark Behavioral and Social Sciences Research Branch National Institute of Dental and Craniofacial Research National Institutes of Health University of Florida September 17, 2010

Points to Cover Overview of behavioral and social sciences research (BSSR) at the NIDCR NIDCR perspective on Health Behavior Theory Funding Opportunities for BSSR at NIDCR Resources for applicants/investigators

“Locations” of BSSR at NIDCR Behavioral & Social Sciences Research Branch Melissa Riddle, Ph.D. – riddleme@mail.nih.gov David Clark, Dr.P.H. – david.clark2@nih.gov Center for Clinical Research Ruth Nowjack-Raymer, Ph.D. – nowjackr@mail.nih.gov Donald (Don) Denucci, D.D.S. – denuccid@mail.nih.gov Research Training and Career Development Branch Kevin Hardwick, D.D.S. – kevin.hardwisk@nih.gov Leslie Frieden, Ph.D. – friedenla@nidcr.nih.gov

What sorts of BSSR do we fund? Basic: qualitative and quantitative studies to understand the behavioral and social determinants of oral and craniofacial health Applied: rigorous studies of behavioral or social interventions that target oral or craniofacial health and its determinants, and how to make efficacious interventions sustainable in real-world settings For both basic and applied research, public health relevance is a priority.

Health Behavior Theory: NIDCR Perspective on the State of the Science A strong health behavior theory gives a specific, testable, causal explanation for health behavior(s) Existing health behavior theories may not be strong, and/or may not be relevant or add value in your own research Regardless of whether you draw from existing theory or develop an innovative theory, behavioral and social research at the NIDCR should be guided by strong health behavior theory

Defining the Terms The literature often confuses theories, planning models, and conceptual frameworks If there is no consistent definition, is it realistic to expect the field will all be on the same page?

Conceptual Frameworks Conceptual frameworks have identified the importance of looking at multiple levels for potential causes of oral disease/health For instance, Fisher-Owens’ ecological model (2006) highlights the importance of individual, family, community, and social factors in oral health But conceptual frameworks such as this one are not health behavior theories. They do not specify testable causal relationships.

Intervention Planning Models Planning Models guide intervention development RE-AIM (Glasgow, 2007) PRECEDED-PROCEED (Green et al, 2005) Stage Model of Behavioral Therapy (Rounsaville et al, 2001) But planning models are not health behavior theories. They do not specify testable causal relationships.

Health Behavior Theories Some health behavior “theories” describe behavior change, but don’t offer causal explanations of behavior The Stages of Change Model is one example of such a theory From NCI’s Theory at a Glance publication: http://www.cancer.gov/PDF/481f5d53-63df-41bc-bfaf-5aa48ee1da4d/TAAG3.pdf

Health Behavior Theories Some health behavior theories are widely-used, but focus narrowly on one (or only a few) potential causes of health behavior The Theory of Reasoned Action is one example of such a theory From NCI’s Theory at a Glance publication: http://www.cancer.gov/PDF/481f5d53-63df-41bc-bfaf-5aa48ee1da4d/TAAG3.pdf

Picking a theory What is the best theory? The one that best explains the factors that influence your target behavior(s) Caution: theories that are too simple or too complex may not provide the best explanation

How does HBT fit in to what sorts of BSSR do we fund? Basic: qualitative and quantitative studies to understand the behavioral and social determinants of oral and craniofacial health Applied: rigorous studies of behavioral or social interventions that target oral or craniofacial health and its determinants, and how to make efficacious interventions sustainable in real-world settings For both basic and applied research, public health relevance is a priority.

Basic BSSR at NIDCR Working definition: Qualitative and quantitative studies to understand the behavioral and social determinants of oral and craniofacial health Central question: What are the causes of oral disease/oral health? A good HBT provides a specific, causal explanation for the problem Basic BSSR at NIDCR should aim to clarify causal relationships, aka the “mechanisms of action” connecting behaviors of interest. Studies that demonstrate that variables are related to oral health, without describing and testing a theory or rationale for that relationship, are of lower priority to the NIDCR, and tend not to do well in peer review.

Funding Opportunities for Basic BSSR at NIDCR Small Research Grant for Data Analysis and Statistical Methodology (R03) Supports “secondary data analyses or statistical methodology using existing dental or craniofacial database resources” (pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology) Methodology and Measurement (R03, R21, R01) Encourages research that will “improve the quality and scientific power of data collected in the behavioral and social sciences” (innovations in research design, data collection and analysis techniques, measurement) Social Network Analysis and Health (R21, R01) Social networks are social structures comprised of nodes, which can be individuals, organizations, or even societies. ..One key question is how the structure, characteristics, and temporal dynamics of social networks influence the spread of behaviors, both healthy and unhealthy…Developing better tools for studying the flows of resources and information among organizations and individuals within whole communities could provide clues to why health disparities persist despite efforts to address differences in access to care and interventions and prevention programs targeting the most vulnerable populations.  Parent Announcements for the R01, R21 and R03

Funding Opportunities for Basic BSSR at NIDCR—Cont’d Understanding and Reducing Health Disparities (R21, R01) Encourages research project grant applications employing behavioral and social science theories, concepts, and methods (1) to improve understanding of the causes of disparities in health and disability among the various populations of the United States and *(2) to develop and test more effective interventions for reducing and eventually eliminating health disparities. The goal is to move beyond documenting the existence of health and disability disparities to addressing causes and solutions.” *Even when applied/intervention studies are supported by an announcement in which NIDCR participates, the NIDCR still requires that applicants adhere to the R34/U01 process for intervention research grants

Funding Opportunities for Basic BSSR at NIDCR - OppNet Social Environment RFA-DA-11-003 Effects of the Social Environment on Health: Measurement, Methods and Mechanisms (R01) Opening Date: December 6, 2010 Letters of Intent Receipt Date: December 6, 2010 Application Due Date: January 6, 2011 Sleep RFA-HD-11-102 Sleep and Social Environment: Basic Biopsychosocial Processes (R21) Opening Date: September 8, 2010 Letters of Intent Receipt Date: September 8, 2010 Application Due Date: October 8, 2010 Behavior Maintenance RFA-HL-11-035 Basic Mechanisms Influencing Behavioral Maintenance (R01) Opening Date: September 14, 2010 Letters of Intent Receipt Date: September 14, 2010 Application Due Date: October 14, 2010 Psychosocial Stress RFA-HL-11-033 Psychosocial Stress and Behavior: Integration of Behavioral and Physiological Processes (R01) Opening Date: September 14, 2010 Letters of Intent Receipt Date: September 14, 2010 Application Due Date: October 14, 2010 Self-Regulation RFA-AG-11-010 Basic Research on Self-Regulation (R21) Opening Date: December 6, 2010 Letters of Intent Receipt Date: December 6, 2010 Application Due Date: January 6, 2011 Capacity Building RFA-CA-10-017 Scientific Meetings for Creating Interdisciplinary Research Teams in Emerging Basic Behavioral and Social Science Research (R13) Opening Date: November 14, 2010 Letters of Intent Receipt Date: November 14, 2010 Application Due Date: December 14, 2010 OppNet: http://oppnet.nih.gov/index.asp

Applied BSSR at NIDCR Working definition: rigorous studies of behavioral or social interventions that target oral or craniofacial health and its determinants, and how to make efficacious interventions sustainable in real-world settings Central question: How do we intervene to improve oral disease/oral health? A good HBT provides a specific, causal explanation for why an intervention is expected to improve oral disease/oral health Applied BSSR at NIDCR should aim to clarify causal relationships, aka the “mechanisms of action” connecting an intervention with behaviors of interest. Studies that demonstrate that an intervention improves oral health, without describing and testing how and why the intervention works, are of lower priority to the NIDCR, and tend not to do well in peer review.

Funding Opportunities for Applied BSSR at NIDCR NIDCR Clinical Trial Planning Grant (R34) Provides support for the development of a comprehensive clinical trial protocol and associated documents, including a Manual of Procedures (intervention manual, consent forms, staff training materials, data and safety monitoring plan, etc.) Does NOT support pilot data collection (use Parent R21 for pilot data collection) Special considerations for applied BSSR Need to establish “proof of concept” for the proposed theory of the intervention (i.e., mechanisms of action) Need to establish acceptability for the target population Need to develop methods for ensuring fidelity of delivery of the intervention ?Need to plan for long-term sustainability of the intervention? NIDCR Clinical Trial Implementation Cooperative Agreement (U01) “A clinical trial implementation cooperative agreement application should describe all necessary components to successfully conduct a clinical trial. This would include a description of the administrative structure, the identification and qualifications of the study chair, the data coordinating center, appropriate clinical site(s) and specialized core facilities (if applicable). The materials developed in the R34 phase will allow the applicant to initiate study staff training followed by study subject recruitment soon after an expedited peer review and final NIDCR approval of the clinical study application. In order not to delay the initiation of the study, the peer review and award of grant will be completed within four months of the receipt of the application when possible.” The proposed initiative would support the development or adaptation of a behavioral or social intervention to improve oral health, along with the collection of pilot data in three areas: 1) the feasibility and the acceptability of the intervention; 2) the potential sustainability of the intervention and any changes to the intervention and/or delivery system that might be needed for sustainability; and 3) the plausibility of the proposed mechanisms of action of the intervention.  

Resources for Applicants & Investigators Consult with colleagues Contact NIDCR & NIH staff Watch for NIDCR announcements & “concept clearances” Sept 2009: Formative Research Towards the Development of Effective Behavioral and Social Interventions to Improve Oral and Craniofacial Health May 2010: Individual Tailoring and Community Targeting of Behavioral and Social Interventions to Improve Oral Health Volunteer for peer review service (http://cms.csr.nih.gov/PeerReviewMeetings/StudySectionReviewers/ServiceasReviewers.htm) Advanced Training Institute on Health Behavior Theory & other NIH workshops (http://cancercontrol.cancer.gov/workshop/) Special Journal Issue on BSSR intervention research – JPHD, March, 2011

Contact Us! Melissa Riddle David Clark NIDCR Behavioral & Social Sciences Research Branch 6701 Democracy Blvd. Bethesda, MD 20892 http://www.nidcr.nih.gov/Research/DER/BSSRB.htm Melissa Riddle riddleme@mail.nih.gov 301-451-3888 David Clark David.Clark2@nih.gov 301-594-4814