Mary A. Pentz - US grants

The purpose of the proposed research is to evaluate the emotional health promotion capability of a causal modeling and intervention strategy for stress prevention. The strategy is aimed at enchancing the development of social competence and minimizing the negative impact of transitional life events in early adolescents. Emotional health will be gauged by prevention of stress and emotional/behavioral disorder. The specific aims include: (1) Validating the impact of transitional life events in early adolescents (e.g., grade and school transitions); (2) testing a causal model of stress based on the direct influence of predisposing, precipitating, and social stressor (negative life events) variables and on the mediating influence of competence, support, and self value; (3) elucidating emotional health trends in adolescents identified as at risk for stress; and (4) evaluating the effects of social competence training on stress prevention. Five cohorts (grades 4 through 8; N=450) will be evaluated each semester for three years on cognitive, affective, and behavioral indices of stress; and independent sample added in Year 2 will provide cross-lagged cohort comparisons (grades 5 through 9; N=675). The overall design is cohort-sequential, with a modified Solomon four-group design subsumed in Year 2. Screening, baseline, pre- and post-training, and follow-up data will provide assessment of normative developmental trends in emotional health as well as maintenance and generalization of training effects. Based on documented transition proneness and social competence need in early adolescents, the central hypotheses are: (1) that negative transitional events should contribute to stress; (2) that social competence in combination with self value and positive social support should reduce direct influences on stress; (3) that social competence training should enhance social competence and therefore prevent or reduce stress; and (4) that stress in combination with low levels of competence, support, and self value should contribute to the onset of emotional/behavioral illness. The proposed research expands the concept of diathesis stress by including mediating influences.

community mental health services; drug abuse education; drug abuse prevention;

The proposed project expands long-term evaluation of an ongoing community- based drug abuse prevention program (Midwestern Prevention Project) that has emphasized intervention during early adolescence, by initiating intervention earlier in childhood. The proposed program is tailored to the changing developmental needs of children and adolescents and includes school, parent, and community components. The original community program yielded significant reductions in monthly, weekly, and daily use of tobacco, alcohol, and marijuana, and lifetime use of some illicit drugs from adolescence to early adulthood. However, process and formative evaluation research suggests a need for stronger programs that are initiated earlier in elementary school and continued at least through middle school. The study will evaluate short-term and long-term effects of comprehensive school-community programming in Indianapolis that is initiated during elementary school and is implemented from grades 4 through 7. Feeder middle schools will be stratified according to current participation in DARE and then randomly assigned from within strata to a comprehensive elementary+middle program or middle program condition, both with parent involvement and community support revised from the original community intervention to include a focus on academic and social competence, and violence as well as drug abuse prevention (N=48 elementary schools, 24 middle schools, 2400 individuals measured from all classrooms each year from the 1996 fourth grade cohort as it moves through time). Measures include annual surveys of students, parents, teachers, community leaders, and individuals knowledgeable about local policy; expired air; and school archival records on drug-related infractions, absenteeism, policy and achievement. Regression, growth curve, and causal modeling analyses will be used to evaluate program effects. The proposed project continues and expands the scope of the current project by testing the efficacy of a combined elementary and middle school year program with parent and community components. The results of the study should yield important information about the incremental effects of a community program initiated in childhood compared to programming focused only on adolescents.

DESCRIPTION: (Applicant's Abstract) Few longitudinal studies exist that evaluate changes in predictors of drug abuse or prevention program effects over multiple risk periods or that systematically address risk factors, program effects, and program effect mediators in the same study. The specific objectives of this longitudinal etiology and prevention study are to evaluate: (1) long-term effects of an earlier community-based prevention program for adolescents on reducing drug abuse and related problem behaviors (drunk driving, social dysfunction, job and school drop-out, unprotected sex) and on increasing participation in prevention and health promotion activities in adulthood (healthy lifestyle choices); (2) changes in mediators of early drug use risk, particularly mediators targeted by the earlier community program; and (3) changes in the strength and pattern of personal, social, and environmental drug abuse predictors as individuals move through four potential risk periods (early adolescence, adolescence, onset and end of early adulthood). Two expanded panels of adolescents will be tracked through early adulthood, half of whom were previously assigned to a control group or a group that received a comprehensive community-based intervention that included school, parent, community organization, health policy change, and mass media program components, beginning in middle school. Three additional waves of survey and archival data on two panels of individuals from Kansas City and Indianapolis (75% white, 23% African-American, 2% Other; 51% female; 63.2% low SES; 23.5% inner city; N=2646) will be collected. Merged with up to nine previously collected waves of data, this proposed study will include subjects spanning the ages 12-29. Panels represent an overall 17% oversample compared to previous waves to enable stratified tests of drug use development and program effects by ethnicity. Based on 1993-94 data, 25.0% reside outside of the original study area, .4% have died, .7% are in prison, 2.5% needed treatment for drug abuse, and 4.4% were in trouble with police over a drug related problem. Hierarchical regression, growth curve, and structural equation analyses will be compared for their ability to predict drug abuse development and program effects with models that include personal, social, and environmental influences. The proposed study is important because it encompasses four potential periods of drug use risk (early adolescence, adolescence, onset of early adulthood, end of early adulthood--ages 12-29); includes multiple waves of data on two diverse populations; is large enough to enable test replication across sites and population sub-groups; incorporates and compares sophisticated analytical techniques to evaluate models of drug use and program effects; and represents the most long-term study of drug abuse prevention program effects in the U.S. Results should inform at least two important questions relevant to drug abuse prevention: whether a drug prevention program aimed at adolescents has the capacity to affect drug abuse, problem behaviors, and healthy lifestyle choices, and whether patterns of risk factors change over different periods, which would suggest that prevention efforts may require a different emphasis depending on age/stage of risk implemented.

The objectives of this five-year study are to increase community use of evidence-based prevention programs and subsequently decrease adolescent drug use. The specific aims are to: (1) test the effects of two prevention training interventions with high national diffusion potential (televised training with interactive satellite down-link capability, training + off-site technical assistance, control), on community leader and community adoption, implementation, and dissemination of evidence-based prevention programs; and (2) test the effect of these interventions at the community level, and the effect of a classroom-based media literacy program at the school level, on increasing adolescent attention to the national anti-use campaign, use of local media for promoting prevention messages and programs, and changes in use norms and behaviors. Two research designs are used: at the community level, communities will be randomly assigned from within each of 8 states to one of the three training conditions (5 training segments across two years on needs assessment, community organization, media literacy/advocacy, school, and parent programs; training + assistance, control; N=24 communities); at the school level, two middle/junior high schools within each community will be randomly assigned to a media literacy program on interpreting and counteracting drug use images, use of local media, and social norm expectations; or control; N=48 schools). At the community level, subjects are community leaders (youth/recreation agency, school, parent, policy/government, law enforcement, media, business, special interest; n=25-35 per community; N=840). At the school level, subjects are all 6,7,8th grade students from 2 classes/school and parents of 7th graders; N=5,760). The measurement design is longitudinal, with community leaders and students followed annually for four years with surveys and archival records. Independent variables include intervention and time; covariates include demographic variables, community readiness, and drug use risk; dependent variables include participation in community organization for prevention and use of evidence-based prevention programs and local media for prevention; and drug use norms and drug use. Intervention effects will be analyzed with regression, growth curve, structural equation modeling, time series, and cost-effectiveness analyses, with community, school, and individual as the units of analysis. Results should be generalizable to all communities and cities with satellite down-link capabilities (the majority of U.S. communities). The findings should help determine whether evidence-based programs supported by federal research agencies and Congress can be disseminated to and used by communities at relatively low cost, with a relatively high degree of fidelity, and whether communities can use available mass media constructively to enhance prevention initiatives and anti-use norms.

Few longitudinal studies exist that evaluate changes in predictors of prevent program effects in individuals with different growth trajectories over multiple risk periods, or that systematically address risk factors, program effects, program mediators and effects of different program components in the same study. In addition, no preventive intervention study, to our knowledge, has attempted to evaluate potential cross- generation effects from targeted individuals to their later offspring. The specific objectives of this longitudinal etiology and prevention study are to evaluate: (1) long-term effects of an early community-based prevention program for adolescents on reducing drug abuse and related problem behaviors and increasing participation in prevention and health promotion activities in adulthood; (2) changes in mediators and moderators of early drug use risk, particularly mediators targeted by the earlier community program; (3) changes in the strength and pattern of personal, social, and environmental drug abuse predictors as individuals move through four potential risk periods (early adolescence, adolescence, onset and end of early adulthood); and (4) effects of the earlier program on the oldest child of these adults. Two panels of adults will be tracked through the end of early adulthood, included school, parent, community organization, health polity change, and mas media program components, beginning in middle school. Two additional waves of survey and archival data on two panels of individuals form Kansas City and Indianapolis (78% white, 20% African American, 2% Other; 51% female, 64% low SES; N=2544) will be collected. Merged with up to nine previously collective waves of data, this proposed study will include subjects spanning the ages 12-31 and the index (oldest) children of the approximately 1/3 of the subjects who do not have children ages 3 or older. Hierarchical regression, latent growth curve, growth mixture model, and structural equation analyses will be compared for their ability to predict drug abuse development and program effects with models that include personal, social, and environmental influences. Effects of different program components will be evaluated (school, parent, mediated, community organization, policy change), as well as effects of the program as a whole on six hypothesized trajectories of drug use (abstainers, early stable users, experimenters, late stable users, quitters, and erratic users). The proposed study is important because it encompasses four potential periods of drug use risk from ages 12-31, includes multiple waves of data on two diverse population, is large enough to enable test replication across sites and population sub-groups, incorporates and compares sophisticated analytical techniques to evaluate models of drug use and program effects, and represents the most long-term study of drug abuse prevention program effects in the U.S. Results should inform at least four important questions relevant to drug abuse prevention: (1) whether a drug prevention program originally aimed at early adolescents has the capacity to affect drug abuse, problem behaviors, and healthy lifestyle choices in adulthood; (2) whether patterns of risk factors changes over different periods of early adolescence to the end of early adulthood; (3) whether long-term prevention effects achieved thus far on adults extend to prevention practices with their children; and (4) whether the original prevention program has affected or has the capacity to affect risk and protective factors in the children of these adults.

[unreadable] DESCRIPTION (provided by applicant): The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. The aim of this project is to adapt and revise parts of two nationally recognized evidence-based programs for drug prevention (the school program PATHS, and the parent skills training program STAR) for use with children in grades 4, 5, and 6 with the express purpose of obesity prevention. To the investigators' knowledge, there is no school-based obesity prevention program that translates methods from other prevention areas, incorporates affect (specifically impulse control and emotional regulation) and executive function (planning and organization), and addresses social competence-building (a major developmental task of these childhood years) as a means to prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange County will be randomly assigned to either the universal obesity prevention program or a delayed intervention control (N=3460 4th grade students and their parents). The adaptation is planned as a three year program with boosters, administered by trained teachers. The population is ethnically diverse (36% white, 57% Hispanic, 6% Asian; 48% on free/reduced lunch programs). Self-report measures will be administered on the longitudinal panel sample at baseline in Fall of 4th grade, and at end of 4th, 5th, and 6th grade on cognitive, affective, and behavioral variables related to the intervention; anthropomorphic measures of BMI and waist circumference will be administered at the beginning of 4th grade, and at end of 5th and 6th grade. Teacher, administrative, and parent surveys will be administered on the same schedule to measure school environment for physical activity and food; child emotional regulation, social competence, executive function, and internalizing and externalizing behavior, and parent-child communication. Program implementation will be measured by teacher self-report and research staff observations. Data will be analyzed with mixed model regression to capture effects of school and classroom, structural equation modeling to test the theoretical model of change, and limited growth curve analysis to evaluate developmental trends in mediators and outcomes across the three grades. Findings should be generalizable to most elementary schools, and will be used to develop evidence-based program standards for childhood obesity prevention. [unreadable] [unreadable] [unreadable]

? DESCRIPTION (provided by applicant): Most premature morbidity and mortality from cancer is preventable through primary prevention involving interventions to reduce cancer risks or secondary prevention involving early detection, treatment, and follow-up care. Despite the clear need for cancer prevention training, there has been very little support for such programs. For the last 30 years, the University of Southern California (USC) training program in cancer control and epidemiology has been one of a small number of T32 programs contributing to the nation's pool of qualified cancer prevention researchers. During that time, we have trained 54 postdoctoral fellows and 32 predoctoral trainees, over 92% of whom go into careers of cancer-related research and/or teaching. In the past ten years, we have trained 18 postdoctoral fellows (93% who have gone into cancer research careers) and 22 predoctoral trainees (100% of whom have gone into cancer research postdoctoral fellowships or careers).This proposal requests continued support for the Cancer Control and Epidemiology Research Training Program at USC, where program and collaborating faculty are internationally recognized for their research in cancer epidemiology/etiology, primary prevention, early detection, and treatment and follow-up care compliance. The successful record of extramural funding and collaborative investigations of USC Department of Preventive Medicine, Institute for Prevention Research, and faculty and resources of the USC Norris Cancer Center (of which the majority of T32 mentors are members), provide an exceptionally rich training environment. The aims of this proposal are to continue the funding for training of 1) five pre-doctoral scientists and 2) five pot-doctoral scientists in cancer risk, prevention, and control, to prepare them for careers in cancer prevention research. Predoctoral trainees receive the PhD degree in Health Behavior Research (HBR) and are selected from among the most promising upper level HBR graduate students in IPR and the Department of Preventive Medicine. While the PhD program generally takes 5 years, T32-supported trainees are selected during their second or third year of training. Predoctoral training includes structured course work and all trainees attend weekly research seminars, directed research, weekly research team meetings, and writing groups. The three-year postdoctoral program requires course work or the equivalent in cancer epidemiology, grant writing, publication writing, and advanced statistical methods and design. Emphasis is placed on involving fellows in ongoing research projects, and assisting them in developing their own research programs. All pre- and post-doctoral trainees are trained to conduct interdisciplinary, collaborative research in teams, and are encouraged to participate in mentoring responsibilities with peers. All trainees are required to take a course on research ethics and USC Centers of Excellence in Teaching and Research courses in publications, proposal development, and career planning and development.

[unreadable] DESCRIPTION (provided by applicant): As obesity risk increases in adults and youth in the U.S., the risks for multiple types of disease also increase, including at least 6 types of cancer. Smart growth communities represent 1 of 5 major building trends in the U.S., today, and the one most associated with obesity prevention potential. However, smart growth communities have not been systematically evaluated in research, either as the planned set of 10 principles or in terms of the combination of individual factors that contribute most to obesity risk prevention. The aim of this translational research study is to evaluate the longitudinal, temporal relationships of an entire built environment, the smart growth community, on family obesity risk, and to evaluate changes from this environment that mediate this risk. The research design is a 3 group hybrid design, involving aspects of both matching and a randomized trial. The sample consists of 600 families (1 index parent, 1 index child between age 10-14, 36% white, 44% Hispanic, 5% African-American, 11% Asian, 4% other). The intervention group is new resident families who are randomly drawn to live in a low-moderate income smart growth community in California (n=300). The randomly selected control is families matched in demographic and income characteristics to the intervention group who are interested in living in a smart growth community, but are not drawn in the random lottery (n=150). The matched control is 150 families who are matched on demographics and live adjacent to the smart growth community. The sample is stratified, with 50% moderate income single family home owners, 25% low- moderate income renters of multi-family residences, and 25% very low-low income renters. Measurement is longitudinal, with 4 waves of anthropomorphic, accelerometry, communication network, and self-report data on physical activity, obesity risk (BMI), and food intake; GIS mapped environmental indices that reflect measurable built environment characteristics of smart growth; and archival data on regional planning, traffic, and density. Analyses will evaluate the effects of all and individual smart growth principles on obesity risk, including multi-level modeling controlling for contextual effects of neighborhood and family variables, growth and growth mixture modeling to evaluate trajectories of physical activity changes, and structural equation modeling to test theoretical models of relationships. The findings are expected to have significant implications for the inclusion of health and obesity prevention factors in community planning. Results are expected to generalize across rural, suburban, and urban communities in the U.S. PUBLIC HEALTH RELEVANCE: Smart growth is one of five major community planning trends sweeping the U.S. today. The CDC estimates that 1/3 of all existing and new communities will use smart growth principles in their planning within 5-7 years. The 10 principles constituting smart growth have broad application to urban, suburban, and rural areas, as well as to unused infill and green field spaces. However, while a few of the 10 individual principles, e.g., green space allotment for walking, have been shown to relate cross-sectionally to increased physical activity, there has been no study of smart growth in its' entirety as a intervention for preventing obesity and improving health, no comparison of the relative impact of its' individual principles, and no longitudinal or randomized study of its' effects. The proposed study is innovative in that it involves the partnership of a transdisciplinary team of researchers, regional planners, a county public health department, and a major health coalition in evaluating the effects of smart growth on changing physical activity, eating behavior, BMI, and overall health practices in a randomized trial, the first of its' type. The findings are expected to have a significant impact on future community planning related to obesity prevention and health promotion, and will be disseminated through county public health and regional planning departments. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Most premature morbidity and mortality from cancer is preventable through primary prevention involving interventions to reduce cancer risks or secondary prevention involving early detection and treatment of localized disease. Despite the clear need for cancer prevention training, there has been very little support for such programs. For the last 19 years, the USC training program in cancer epidemiology and control has been one of a very small number of T32 programs contributing to the nation's pool of qualified researchers in cancer prevention and control. To date, we have trained 53 postdoctoral fellows and 36 predoctoral trainees, all but two with active careers in cancer-related research and/or teaching. This proposal requests continued support for the cancer control and epidemiology research-training program at USC, where program and collaborating faculty are nationally and Internationally recognized for their research in cancer epidemiology/etiology, primary prevention, early detection, and treatment compliance. The successful record of extramural funding and collaborative investigations of USC cancer control faculty, coupled with the resources of the USC-Norris Cancer Center, provide an exceptionally rich training environment. Funds are requested for five predoctoral and five postdoctoral trainees. Postdoctoral positions are allocated to behavior and epidemiology research training emphasizing collaborative studies. The two-year postdoctoral program requires course work or the equivalent in the biological basis of cancer, cancer epidemiology, grant writing and statistical methods. Emphasis is placed on involving fellows in ongoing research projects, and assisting them in developing their own research programs. Predoctoral trainees receive the PhD degree in Health Behavior Research (HBR) and are selected from among the most promising upper level HER graduate students in the department. While the Ph.D. program generally takes 5 years, T32-supported trainees are selected during their second or third year of training. Predoctoral training includes structured course work and all trainees attend weekly research seminars, directed research, weekly research team meetings, and writing groups. All trainees must attend a mini-course on research ethics. RELEVANCE: The USC training program in cancer epidemiology and control has strong relevance for the improvement of public health, in that it will provide predoctoral and postdoctoral training to highly qualified individuals, to prepare them for careers in cancer prevention research.

The Methods Core (MC) will provide centralized services to address research questions and issues pertaining to study design, measurement, analysis, and methods training to the TCORS research projects, other cores, and investigators. The MC will assure that measurement and data collection approaches are refined to be useful in various vulnerable populations and will also pro-actively refine and adapt data collection tools for use in diverse vulnerable populations, providing an internal service and one that will be of value to the other TCORS. The MC will offer services and consultation on identification, development and validation of instruments, and provision of state-of-the-art, culturally appropriate interview, physiological, psychosocial, behavioral community-based, archival, GIS, and observational measures, data management, statistical analysis, training and methodological and statistical consultation. The MC will maintain a web- based system to provide a central repository for data and facilitate instrument and file sharing among Center investigators, regulatory science trainees, and other funded TCORS. The MC core members bring expertise in discipline-specific measurement, design, and analytic techniques, such as advanced methodologies, statistical modeling, psychometrics analysis, qualitative data analysis, community-based participatory research (CBPR) methods, and behavioral data collection. The Specific Aims of the Methods Core are: Design and Sampling. To assist in the review of research design protocols and to develop and implement appropriate sampling methodology for center studies and cores and to advise the Population Core on procedures for maximizing participation and tracking rates and minimizing attrition. Measurement Validation and Development. To assist in the identification of existing measures and development and validation of new measures that can be applied across projects. Data Management. To develop and maintain a website to serve as a centralized, secure web system to facilitate sharing of instruments and data sets across projects, conduct data entry for the projects. Data Analysis. To provide statistical and computer support for USC TCORS projects and regulatory science trainees, and to share new statistical methods with other TCORSs. Consultation, Training and Integration. To provide consulting to investigators and staff in measurement and analysis strategies, and collaborate in training in regulatory science methodologies with the Research Training and Education Core. RELEVANCE (See instructions): The Methods Core coordinates existing resources, procedures and expertise to make them available to all the investigators in the center, and provides guidance to all studies on study design, statistical analysis, and measurement development. The Methods Core will help to assure that the research of the USC TCORS is as informative as possible.

DESCRIPTION (provided by applicant): The University of Southern California (USC) Tobacco Center of Regulatory Science (TCORS) addresses the cross-cutting theme of tobacco use among vulnerable populations, proposing an agenda of methods development and research that will help to assure that the activities of the Food and Drug Administration (FDA) reach to the diverse groups at risk for nicotine addiction and the adverse consequences of tobacco use. The proposed USC TCORS directly responds to RFA-DA-13-003 with a highly experienced multi- disciplinary team of investigators who already work together on tobacco research with populations considered vulnerable to tobacco use and nicotine addiction. There are three overall research aims of this TCORS: 1) evaluate marketing, social influence, social media, and network influences on tobacco use and product choice, emphasizing vulnerable populations, with the ultimate aim of identifying ways to reverse or counteract these influences; 2) examine tobacco product distribution and regulation among local vendors, whose stores are a key point for purchase, contact with industry marketing and promotion, and regulatory education initiatives; 3) examine different topographies of tobacco use, integrating phenotypic variables with personal, social, cultural and environmental variables to determine how future tobacco control initiatives may be tailored to different vulnerable groups. These aims are met through three Research Projects which have overlapping elements: 1) internet-based investigation of marketing and social media influences drawn from diverse populations; 2) a study of small tobacco retailers in California and the impact of community environment and local regulatory campaign efforts on both vendor practices and consumer behavior; 3) a study of tobacco use trajectories and use topography in an established population-based cohort. This theory- based research acknowledges the dynamic interplay between tobacco regulatory, control, and industry systems as they affect tobacco use in vulnerable populations. The USC TCORS will have five cores: Methods, Population, Pilot Programs, Training and Education, and Administrative. The latter will be responsible for overall coordination and integration of research, training, and core activities; communication with other TCORSs, and dissemination of findings. All of the research studies and cores are designed to promote tobacco regulatory science as a discipline, support research and collaboration within and across other TCORSs, and advance new research questions and methods. The USC TCORS is expected to provide evidence that will enhance the FDA's capacity to impact on public health through tobacco regulation. RELEVANCE: The USC Tobacco Center of Regulatory Science (TCORS) focuses on populations that are at high-risk for use of tobacco products and addiction in order to help the FDA reduce tobacco use and its disease burden. Addressing FDA priorities, researchers will examine social media and small retailers as ways that the tobacco industry reaches vulnerable populations, and how early smoking patterns predict tobacco product use and addiction. The TCORS will generate new research and training methods for regulatory science.

With the implementation of regulatory and other activities under the Family Smoking Prevention and Tobacco Control Act by the Food and Drug Administration (FDA), there is now a need for research in tobacco regulatory science that addresses the most critical gaps and uncertainties relevant to the FDA programs. The University of Southern California (USC) Tobacco Center of Regulatory Science (TCORS) will complement the training of discipline-based researchers with the additional understanding and competencies needed by scientists in tobacco regulatory research. The USC TCORS will recruit trainees at the pre- doctoral and post-doctoral levels and also identify several established investigators who will transition into research within the domain of tobacco regulatory science. The training model will be based around the core knowledge and competencies needed for researchers in tobacco regulatory science who need a deep and general understanding of evidence-based policies and of the translation of scientific evidence into initiatives that may be regulatory or non-regulatory. To this understanding, the USC TCORS will add specific and focused familiarity with the Family Smoking Prevention and Tobacco Control Act (the Act) and the activities of the FDA under the Act. Trainees also need a broad and multidisciplinary understanding of tobacco and health and of tobacco control. The Training Directors (Drs. Jonathari Samet and Heather Wipfli) have extensive experience in research training generally and in tobacco control specifically. The Research Training and Education Core will: 1) develop a competency-based research and training plan that includes a core curriculum and a career development program; 2) develop courses in tobacco regulatory science available onsite and in a distance-based format; 3, recruit pre-(N=3) and post-doctoral (N=3) trainees, giving emphasis to candidates from vulnerable populations, as well as transitioning several established investigators into tobacco regulatory science; and 4) use distance-based approaches for collaboration across the TCORS in education and training. RELEVANCE (See instructions): The USC TCORS will train researchers who will be able to carry out studies that support the FDA in its role of reducing the public health impact of tobacco use. The scientists trained will include young pre-doctoral students, post-doctoral researchers, and established investigators. They will gain new skills to carry out research in tobacco regulatory science, increasing the number of researchers in this field.

Early initiation of smoking and rapid progression during the key adolescent and young adult period predict chronic and addicted smoking in adult life and high risk for health consequences. However, there has been little research on how adolescent smoking trajectories relate to future vulnerability to industry marketing and emerging products intended to sustain nicotine addiction. This project addresses the hypothesis that the early course of cigarette smokino is a key determinant of future nicotine dependence and vulnerability to point-of-sale and electronic marketing, resulting in future use of new non-cigarette products and polv-tobacco use. These questions are addressed using data from over 12,000 largely Hispanic and non-Hispanic White participants recruited from Southern California schools into the Children's Health Study cohort between 1993 and 2002. Smoking data have been collected yearly through high school graduation at age 18. Using these data and state-of-the-art statistical modeling, adolescent cigarette smoking trajectories will be characterized based on initiation and progression patterns. Associations of these trajectories with neighborhood and community environmental, demographic and social factors, and with marketing exposure, based on tobacco retailer proximity and density at home, school and a novel route to school metric, will be assessed. Samples of smokers and at-risk non-smokers in the younger wave of recruitment currently 17-18 years of age (N=600) and of smokers from eariier waves now 26-36 years of age (N=450) will be re-interviewed and followed prospectively to assess the relationships of early life smoking trajectory with tobacco product perception, attitudes and beliefs, persistence of use and difficulty quitting smoking. Specific types of tobacco marketing at point-of-sale, through electronic and social media, and interpersonal influences that amplify the risk of different trajectories of childhood tobacco use will be identified. A hierarchical modeling approach will integrate information on early life smoking trajectory, marketing, perceptions, attitudes and beliefs across life stages and over follow-up to elucidate the role of each in use of new tobacco products. The study will yield refined information on nature and characteristics of early life smoking phenotype trajectories and on response to marketing relevant to regulation and prevention among vulnerable populations. Further, it will clarify how eariy-life cigarette smoking serves as a gateway process to other forms of tobacco product use, which could be amplified by tobacco marketing. It addresses FDA research priorities: vulnerability, perceptions, attitudes and beliefs, understanding new product use, and marketing.

For over 20 years most tobacco industry expenditures for advertising and promotions have been focused on the retail environment (FTC 2012 a, b,). This has been especially true in vulnerable communities heavily targeted by the tobacco industry. To correct this disparity, we need to understand the retail environment among vulnerable populafions; since the enactment in 2009 of the Family Smoking Prevenfion and Tobacco Control Act (The Act) giving the Food and Drug Administration's (FDA) regulatory authority. For this reason, the specific aims of Project 2 are: 1) to examine knowledge, attitudes, beliefs and behaviors of small independent retailers in vulnerable communities regarding compliance with FDA; 2) to examine opfimal non- tradifional ways (social media sites, online videos, text messaging, blogs, smartphone applicafions, wireless communicafion, Facebook, Twitter, use of cell phones (iPhones, Blackberry), and other mobile channels; and the confluence of traditional broadcast media, with voice and written communication and the Internet) that FDA can use to communicate with retailers and the public in vulnerable communities of predominantly African Americans (AA), Hispanic/Latinos (H/L), Koreans (K); and American Indians (Al); and 3) to examine factors that influence key community informant's public perception of the FDA as a credible source of tobacco product informafion in these communities. Using the Socio-ecological Model (SEM) as a backdrop, community based participatory principles, and engaging community lay health care workers and a cadre of promotores de salud (health promoters) in the conduct of the research, we will focus on the retail environment and on opinions from key community leaders in vulnerable minority communifies engaged in this study. We will randomly select our sample from listings of the Board of Equalization, which contains 38,000 retailers in California with a license to sell tobacco, and based on Census tracts in vulnerable neighborhoods in the Greater Los Angeles area and beyond. Our key opinion leaders sample will be drawn from listings of community stakeholders that form part of tobacco control coalitions and organizations working with these vulnerable populafions in California. We will conduct 16 focus groups (N=192), a retailer survey (N=600) (200 H/L, 200 AA, 100 K, 100 Al), store observafions (200), and GIS/Environmental scans to respond to aims and determine retail density in vulnerable communities. We will analyze data, write periodic reports, manuscripts for scientific publications and share data with FDA, other TCORSs, and stakeholders. RELEVANCE (See instmctions): Project 2 addresses FDA priorities 5 (Communicafions) and 7 (Policy) and the following quesfions: 1) What are the knowledge, attitudes and beliefs of retailers and key opinion leaders about tobacco products and FDA tobacco product regulatory authority, and barriers to compliance with regulations? 1) What are the most effective messages and non-tradifional modes of communicating with retailers regarding FDA's regulatory authority? 3) What are vulnerable community percepfions of the FDA as a credible source of tobacco information; and optimal modes of communicafing? Findings will be crifical for the FDA to maximize compliance with regulations.

The rapidly increasing use of the Internet and social media sites as a source of information presents an opportunity for tobacco promotions and normalization of emerging tobacco products before they can be regulated. Despite the rise in Internet use, there is limited understanding of the role of the Internet and social media sites in transmitting pro-tobacco marketing messages to tobacco users and potential users. More information is needed about the ways in which the tobacco industry places tobacco-related messages online, how individuals receive, perceive, and disseminate information about tobacco products, and how this information impacts their use of tobacco products. This study will provide a comprehensive understanding of the ways in which tobacco companies communicate with their customers and potential customers through social media, as well as the ways in which tobacco users transform and disseminate these messages through their social networks. This will provide important new information about how new tobacco products travel to vulnerable populations and which types of health education messages are needed to counter these influences. The proposed study will achieve the following aims: ¿ Document how the tobacco industry communicates with potential customers online. Monitor tobacco company and brand websites to describe framing and content of tobacco messages about risk and benefits of emerging tobacco products (snus, dissolvables, e-cigarettes and little cigars). ¿ Understand how individuals transform tobacco messages online. Monitor social media sites (Twitter, YouTube) and message boards on tobacco company sites to detect trends in tobacco-related content over time. Conduct content analyses of these messages. Identify online opinion leaders who provide influential information about tobacco products, and document their characteristics. ¿ Describe the tobacco-related messages that individuals receive online. In collaboration with Project #3, which is conducting surveys of young adults in Southern California, determine how individuals communicate and share tobacco-related information through social media. Assess the types of tobacco marketing they receive and share with others. Assess their level of health literacy about tobacco products and identify topics on which public education is needed. Identify communication channels and messages that could be used by FDA to disseminate these messages most effectively.

instmctions): The Population Core (PC) has been established to develop, manage, and retain the various population resources needed to achieve the objectives of the Research Projects and future pilot and developmental projects. The research projects in the USC TCORS draw, in part, upon participants in previously-developed cohort populations. However, each project will also need to expand upon or renew contact with established population resources to succeed. Additional populations have also been identified for several pilot projects being considered within the TCORS. These diverse and complementary population cohorts will be substantively supported and managed within the proposed Population Core. The Population Core will be staffed to provide tracking and retention of existing cohorts, recruitment of new cohorts, and outreach and networking to identify new populations for future research projects, including those initiated through the Pilot Projects Program Core. An experienced team has been assembled to efficiently meet these objectives. RELEVANCE (See instructions): The Population Core will support activities of the USC TCORS, helping it to efficiently track existing study participants and to identify new ones.

The Tobacco Control Act gives the Food and Drug Administration authority over tobacco regulation, yet relatively little is yet known about the impact of this regulation pertaining to new emerging tobacco products, or its impact on diverse, vulnerable populations. To keep pace with rapid changes that are expected to occur in both tobacco product introduction and regulation requires a mechanism to promote multiple, creative, small-scale studies that can be implemented relatively quickly. The USC TCORS Pilot Projects Program Core (PC) serves as this mechanism. The aims are: I.To expand the research questions that are addressed in the three proposed research studies; 2. To fund proof of concept studies in innovative areas such as real- time assessment of retailer impact on tobacco consumer behavior; 3. To fund rapid response studies as changes occur such as the California tobacco regulatory campaign aimed at retailers, which is expected in 2014; 4. To support collaborative studies across TCORSs and across cores; and 5. To encourage regulatory science trainees who are in the Research and Training Core to develop pilot projects that can be used as preliminary studies for later proposal submissions to NIH and similar agencies. The Methods Core will provide measurement and analytical support for the PC; the Population Core will provide participants or recruit new participants for the PC. The PC will also interact with the three main research projects within the USC TCORS through the Administrative Core, particularly for pilot studies that address Aim 1. The PC will follow a six-stage review and operations process that follows NIH guidelines and is designed to generate rapid dissemination of methods and results that c^n inform future tobacco regulatory practices. The stages include: 1. Encouraging applications from a wide range of investigators and from a range of inputs; 2. Funding a portfolio of pilot studies that represent a balance of different types of studies (Aims 1-4); 3. Review and funding; 4. Assistance with expedited IRB processing; 5. Implementation; and 6. Dissemination of findings within and across TCORSs. A total of 16 studies is expected, followed by NIH grant applications. RELEVANCE (See instmctions): The Pilot Programs Core addresses the requirement outlined by the P50 announcement for TCORSs. Its relevance lies in advancing tobacco regulatory science as a discipline, generating new studies and hypotheses for regulatory science, and ultimately, informing strategies to maximize the impact of tobacco regulation-both existing and changing-on tobacco control among diverse populations that are considered vulnerable to tobacco use and addiction.

The Administrative Core is designed and structured to support the activities of the University of Southern California (USC) Tobacco Center of Regulatory Science (TCORS). It will function to assure that the USC TCORS operates effectively and in an interdisciplinary fashion in order to meet to assure that its research, training, and dissemination goals are met. The Administrative Core will work pro-actively to assure complete integration across the Research Projects and Cores around the theme of vulnerable populations that is the focus of the USC TCORS. The Administrative Core will be led by TCORS Co-Program Directors, Drs. Mary Ann Pentz and Jonathan Samet, together offering the broad range of administrative, multidisciplinary research, and translational experience needed to assure the success of the USC TCORS. They will establish the infrastructure needed for effective communications and collaboration across the USC TCORS team and with the other TCORS. It will provide needed administrative support to the TCORS and also carry out financial management activities. The Administrative Core will also organize and convene an external Scientific Advisory Committee and a Community Advisory Board, as well as maintaining an internal group of key advisors. An Executive Committee will be constituted that includes the Project and Core Principal Investigators. The Administrative Core will also oversee quality assurance and quality control for TCORS' projects, maintain the TCORS website and manage other communications activities, including seminars and research-in-progress sessions. Drs. Pentz and Samet will be the first point of contact for interactions with the other TCORS, the FDA, and the NIH.

The University of Southern California (USC) Tobacco Center of Regulatory Science (TCORS) addresses the cross-cutting theme of tobacco use among vulnerable populations, proposing an agenda of methods development and research that will help to assure that the activities of the Food and Drug Administration (FDA) reach to the diverse groups at risk for nicotine addiction and the adverse consequences of tobacco use. The proposed USC TCORS directly responds to RFA-DA-13-003 with a highly experienced multi- disciplinary team of investigators who already work together on tobacco research with populations considered vulnerable to tobacco use and nicotine addiction. There are three overall research aims of this TCORS: 1) evaluate marketing, social influence, social media, and network influences on tobacco use and product choice, emphasizing vulnerable populations, with the ultimate aim of identifying ways to reverse or counteract these influences; 2) examine tobacco product distribution and regulation among local vendors, whose stores are a key point for purchase, contact with industry marketing and promotion, and regulatory education initiatives; 3) examine different topographies of tobacco use, integrating phenotypic variables with personal, social, cultural and environmental variables to determine how future tobacco control initiatives may be tailored to different vulnerable groups. These aims are met through three Research Projects which have overiapping elements: 1) internet-based investigation of marketing and social media influences drawn from diverse populations; 2) a study of small tobacco retailers in California and the impact of community environment and local regulatory campaign efforts on both vendor practices and consumer behavior; 3) a study of tobacco use trajectories and use topography in an established population-based cohort. This theory- based research acknowledges the dynamic interplay between tobacco regulatory, control, and industry systems as they affect tobacco use in vulnerable populations. The USC TCORS will have five cores: Methods, Population, Pilot Programs, Training and Education, and Administrative. The latter will be responsible for overall coordination and integration of research, training, and core activities; communication with other TCORSs, and dissemination of findings. All of the research studies and cores are designed to promote tobacco regulatory science as a discipline, support research and collaboration within and across other TCORSs, and advance new research questions and methods. The USC TCORS is expected to provide evidence that will enhance the FDA's capacity to impact on public health through tobacco regulation. RELEVANCE (See instructions): The USC Tobacco Center of Regulatory Science (TCORS) focuses on populations that are at high-risk for use of tobacco products and addiction in order to help the FDA reduce tobacco use and its disease burden. Addressing FDA priorities, researchers will examine social media and small retailers as ways that the tobacco industry reaches vulnerable populations, and how eariy smoking patterns predict tobacco product use and addiction. The TCORS will generate new research and training methods for regulatory science.

Project Summary/Abstract The aims of the USC Norris Cancer Control Research Program are to elucidate the etiology of cancer risk behaviors in the general population and develop primary prevention interventions that modify cancer risk behavior and enhance secondary prevention, clinical care, and survivorship. These aims serve the overarching goal of reducing and eliminating cancer health disparities among the populations represented in the USC Norris catchment area, with implications for other populations globally. The Program's goals align with the USC Norris strategic plan by: a) developing and testing new interventions that impact the cancer burden; b) applying cutting-edge technology and methodology to assess exposures and disseminate interventions; and c) spanning the continuum of care from primary prevention to survivorship. A hallmark of this Program has been the application of innovative theory and methodology to develop integrated lines of research on cancer risk behaviors and preventive interventions. Given that the diverse, vulnerable, and disadvantaged members of the catchment area reached by the Program's work also reflect the disparities seen at the US population level and the Program makes significant strides in addressing the mission of NCI's efforts in cancer control and population sciences. Recent achievements of the Program, which is led by two internationally-recognized experts, Mary Ann Pentz (primary prevention) and Anna Wu (secondary prevention and survivorship), include 1) understanding mental health comorbidities with tobacco use to inform more tailored smoking cessation programs for vulnerable smokers who have been unable to quit by other means; 2) promoting cultural values and decreasing perceived cultural discrimination as means to improve tobacco prevention and control efforts with Hispanic youth and adults; and 3) utilizing executive function and mindfulness skills training in primary prevention programs that target diet, physical inactivity, and other cancer risk behaviors in youth and applying such interventions to cancer patients, caregivers, and families to improve treatment outcomes. The 30 members represent five schools and 13 departments at USC, and have $15M in peer-reviewed funding (direct costs), 33% of which is from NCI, 27% from other NIH sources, and 33% from other peer-reviewed funding sources. The Program is highly productive with 756 publications of which 17% are inter-programmatic, 23% intra-programmatic and 53% inter-institutional.

1707068 (Choi). This research will develop an integrated human-centered framework for intelligent environmental control in a building. The physiological signals of the occupants, as well as their ambient environmental data, will be integrated by using sensing agents (such as wearable as well as remote sensors) and embedded environmental sensors in the building. This will enable bio-sensing-driven multi-criteria decisions for determining building thermal and lighting system controls that will potentially lower energy usage awhile improving occupant comfort.

This human-centered approach will provide a framework that will 1) address sensor data processing and analysis challenges that are inherent in large and dynamic datasets generated from sensing agents; 2) develop methods for optimizing decisions and solutions to multiple-criteria problems pertaining to occupants' preferences; and 3) establish a human-centered control approach that is integrated with a conventional control system for building retrofits to enable real-time decision making and system optimization that will enhance energy efficient operations and occupants' comfort. Such a three-fold approach can lead to tailored building environmental control systems with the potential for dramatically improving the efficiency of a building's performance, increasing sustainability, and leveraging informatics technology that will improve the occupants' quality of life.

Abstract: Career Enhancement Core Investigators embarking in careers in tobacco regulatory science (TRS) will be most successful by applying a well-established scientific paradigm (e.g., epidemiology, statistics, behavioral pharmacology, community based participatory research) in a novel way to address issues of importance to Food and Drug Administration (FDA). The USC-TCORS Career Enhancement Core (CEC) will provide career building experiences structured to in- crease the combination of knowledge of regulatory issues and skills in a specific scientific area. Over the past four years, USC-TCORS developed a robust training program in TRS, which involved successful training of 3 pre-doctoral, 3 post-doctoral and 2 faculty trainees, who excelled in generating TRS research portfolios and secured related academic and professional positions upon finishing the program. Over the 2018-2023 funding period, the CEC will continue this trend by robustly integrating USC-TCORS junior investigators into the teams of one of Center's the four research projects. We will also enhance our existing pilot research program to en- sure that junior investigators pursue independent research questions aligned with our Center's integrative theme. We will increase support for our postdoctoral investigators to network and gain greater exposure to the broader TRS community, including a weeklong research immersion experience at the FDA, Center for Tobacco Products (CTP), or at other TCORSs. Each of the above career enhancement mechanisms will empower USC- TCORS junior investigators develop skills in the concepts and methods of our integrative theme's scientific framework?the Intersection of Products with Populations. In doing so, we expect each junior investigator de- velop skills in one of the methods utilized to study diversity amongst tobacco products, including social media and big data analytics (applied in Project 1 [P1]), community based participatory research at the location of purchase (P2), longitudinal behavioral epidemiology (P3), or human laboratory research of the tobacco product user experience (P4). We also expect each junior investigator to develop a knowledge of the concepts, re- search methods, and logistics of studying at least one key form of population diversity (e.g., age, race/ethnicity, socioeconomic status, smoking status). Specific Aims of the CEC are to: Aim 1. Recruit advanced pre- doctoral, post-doctoral and new or early stage faculty investigators. Aim 2. Immerse and mentor TCORS jun- ior investigators within the USC-TCORS' four core research project teams to enhance training in the methodol- ogies and disciplines employed by TRS researchers. Aim 3 Provide pilot research funding to TCORS junior investigators to develop independent research projects. Aim 4 Promote core TRS competencies and profes- sional skill building. Aim 5 Evaluate and refine the Center's career enhancement program. The end goal will be that USC-TCORS junior investigators will develop careers in TRS whereby they produce impactful work that guides FDA regulation that benefits the health of the population as a whole.

ABSTRACT: Overall Tobacco products are increasingly diverse. Non-cigarette products now garner a large market share; their use and health impact varies across populations. Youth and young adult non-users of tobacco products are vulner- able to initiation of e-cigarettes?a product posing risks both of nicotine dependence and of combustible tobacco uptake. Yet, middle-aged/older adults may switch from combustible to e-cigarette products with potential health benefits. The FDA is required to consider how regulatory policy has differing impact across subgroups to ensure protection of the ?population as a whole.? Research addressing population diversity is scant. Through its theme, the Intersections of Products with Populations, the University of Southern California Tobacco Center of Regula- tory Science (USC-TCORS) will conduct research on the use and health effects of specific e-cigarette products across populations. We will study e-cigarette product characteristics and marketing approaches hypothesized to increase tobacco product attraction, use, and addiction in youth and young adult non-smokers and have little impact on tobacco product use in older smokers. These e-cigarette products include: (a) non-tobacco flavorings; (b) constituents and devices that produce large vapor clouds; (c) modifiable devices; (d) device designs not resembling cigarettes; (e) cartoons in packaging and advertising; (f) candy flavors or other youth-oriented mar- keting themes. Product standards and marketing requirements limiting non-combustible products with these features to protect young people, while minimizing collateral effects on switching in adult smokers, would satisfy FDA?s mission to protect the overall population. We will provide evidence to forecast whether such requirements would have equitable impact across vulnerable groups defined by ethnicity, socioeconomic status, and sex that are affected by widening tobacco disparities. Four complementary research projects employing differing meth- odologies will test shared hypotheses on variation of the impact of e-cigarette product diversity on tobacco prod- uct use by age, combustible tobacco use, and sociodemographic diversity: (1) characterization of publicly avail- able social media postings of e-cigarette product characteristics and marketing themes that will be linked pro- spectively with tobacco product use behavior in youth and young adults, (2) intercept interviews with customers at vape shops to assess the impact of scenarios of e-cigarette regulation on tobacco product use, (3) cohort studies of associations of e-cigarette product characteristics and marketing exposures with tobacco product use and dependence across 10 years of early life, (4) laboratory tests of the impact of e-cigarette product character- istics and marketing exposure manipulations on product appeal, abuse liability, and other outcomes. Supported by a Center-wide scientific and career development infrastructure, USC-TCORS will provide the FDA with a robust body of evidence to assess how various regulatory approaches to e-cigarettes are likely to affect the health of vulnerable groups and the whole population. Scientific Domains: Addiction, Behavior, and Marketing.

ABSTRACT: Administrative Core The USC-TCORS Administrative Core (AC) will be structured to ensure the Center's component elements coa- lesce, optimally apply our Center-wide integrative theme, and advance the goals of the national network of TCORSs and FDA/NIH's tobacco regulatory science program. Leveraging a strong base of existing resources and programs developed during the current funding period, over the 2018-2023 period, the AC will provide and connect USC-TCORS members with the essential resources specifically tailored to ensure the Center's suc- cess in research and career development. Through specific operational goals and leadership, the AC will be responsible for structuring, initiating, maintaining, and coordinating Center-wide operations to ensure all as- pects of the Center are positioned to further the Center's overall aims. The AC will be led in a Multiple PI struc- ture by TCORS PIs Pentz and Leventhal. Samet and Baezconde-Garbanati will serve as Co-Investigators to assist with a leadership transition plan and coordinate activities with the TCORS Community Advisory Board, respectively. Chou will provide methodological consultation to investigators across the Center. The AC's spe- cific aims are to: Aim 1. Enhance our existing administrative structure and management plan with clear lead- ership and oversight to guide the Center progress towards achieving its objectives by providing: (1a) Mecha- nisms for communication, interaction, and collaboration within USC-TCORS; (1b) Cross-cutting research and career development support services to aid with methodological, data processing, measurement, analysis, IT, and participant assessment to all members; (1c) Program evaluation and assurance of quality and adherence to the scope of the regulatory authority of the FDA Center for Tobacco Products; (1d) Methods to enhance ac- tively dissemination and sharing of research, data and resources. Aim 2. Implement a Rapid Response Pro- ject (RRP) program that includes mechanisms for: (2a) Soliciting, assessing, and prioritizing RRP proposals; (2b) Optimal leveraging of the specific expertise and capabilities of USC-TCORS to ensure capacity to respond to yearly RRP calls on a diversity of topics; and (2c) Monitoring and reporting RRP progress. By accomplishing these aims, the USC-TCORS AC will provide critical infrastructure to advance the Center's scientific and ca- reer development goals as well as facilitate integration with the national tobacco regulatory science network, including partners at FDA, NIH, and other TCORSs.