ENHANCING ADOLESCENT HEALTH PROMOTION ACROSS MULTIPLE HIGH RISK BEHAVIORS RELEASE DATE: August 28, 2002 PA NUMBER: PA-02-159 EXPIRATION DATE: August 23, 2005, unless reissued. National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Nursing Research (NINR), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Heart, Lung, and Blood Institute (NHLBI) invite applications for research related to health promotion/risk reduction among adolescents. Specifically, this announcement seeks applications that 1) identify the determinants of health promoting and health compromising behaviors among adolescents and 2) identify and evaluate interventions and methodologies that show promise for improving the health profiles of adolescents by assessing, preventing, reducing and or ameliorating high-risk behaviors. Investigators responding to this announcement are required to target two or more of the high-risk behaviors in a single application. RESEARCH OBJECTIVES Risky behaviors are defined as activities that have the potential for some type of loss. Parallel to the areas related to health promotion among adolescents outlined in Healthy People 2010 and The Youth Risk Surveillance System (YRBSS), this PA will place emphasis on six priority health risk behaviors that contribute to the leading causes of mortality and morbidity among youth and adults. These six health risk behaviors include tobacco use, unhealthy dietary behaviors, inadequate physical activity, alcohol and other drug use, sexual behaviors, and unintentional (accidents) and intentional behaviors (firearm related injuries). These behaviors are frequently established during the adolescent years and continue on to the adult years. These behaviors are potentially amenable to a variety of health promotion and prevention efforts. For purposes of this announcement, adolescents are defined as individuals age 10-19. In 1999, approximately 40 million US residents were classified as adolescents ranging in age from 10 19 years. This represents 14% of the US population. Among these, approximately 2/3 of the adolescent population was non-Hispanic and 1/3 of other racial ethnic identity. Projections indicate that by year 2050, the nation"s racial ethnic minority groups (Black, Hispanic, American Indian, Asian) will constitute approximately 56% of the adolescent population. While the health status of adolescents differs according to age, gender, race, and ethnic origin, there is ample documentation suggesting that adolescents, regardless of background, engage in high-risk behavior. Today, tobacco use constitutes the single leading cause of preventable death in the United States. Epidemiologists estimate that tobacco related illnesses will be responsible for over 5 million premature deaths among persons age 17 and under who begin to use tobacco products in 1995. Data from the Youth Risk Behavior Surveillance System (YRBS) noted that 80% of individuals who use tobacco began before age 18. Recent trends show increases in cigarette smoking among high school students in the 1990s after years of decline in tobacco use during the 1970s and the 1980s. For example, from 1991-1999, the greatest increase in cigarette use occurred among African American adolescents. This compares with increases of 29% and 25% for Hispanic and White adolescents respectively. In contrast, the use of smokeless tobacco decreased from 11.4% in 1995 to 7.8% in 1999. Poor dietary habits or improper eating habits have been linked to the development of coronary heart disease, cancer, diabetes, osteoporosis, hypertension, and obesity. In 1990, diet along with physical inactivity constituted the second most common "actual cause of death" in the US after tobacco use. Data from the Youth Risk Behavior Surveillance-United States 1999 revealed that 16% of the nation"s students were at risk for becoming overweight while 9.9% were considered overweight. During 1988-1994, 11% of children and adolescents age 6-19 were considered overweight or obese. Despite recommendations for a healthier diet, recent data show that the usual diet of today"s adolescents includes foods high in saturated fat, high in calorie dense foods, and low in fruit and vegetable consumption. Inadequate physical activity has been linked to a variety of adverse health conditions and consequences. In contrast, regular physical activity has been associated with increased psychological and mental well-being, reduced cardiovascular risk, and proper weight maintenance. In 1990, 70% of all high school students participated in moderate to vigorous physical activity in the seven days prior to being surveyed. However, physical activity is noted to decline during the adolescent years leading to further declines in physical activity during the adult years. The need to remain physically active is further underscored by the recent increases in obesity among adolescents and adults in the US. Physical activity is also a leading health indicator identified by Healthy People 2010 along with excess weight and obesity. Healthy People 2010 places special emphasis on increasing the proportion of adolescents who engage in physical activity that promotes cardiovascular fitness 3 or more days a week for a minimum of 20 minutes per occasion. With respect to substance abuse, the use of alcohol and other drugs (e.g., cocaine, marijuana, illegal steroid use) is among the 4 risk behaviors that worsened among adolescents during 1991-1999. Recent data revealed that in 1999, nearly half of high school students (48% female and 52% male) reported drinking 30 days prior to being surveyed. Most adolescents being surveyed reported starting using alcohol or other drugs before entering high school. Nationwide, statistics revealed that in 1999, among adolescents surveyed, 47.2% admitted using marijuana during their lifetime, 9.5% using some form of cocaine, 3.7% admitted using illegal steroids, and 2.4% of those surveyed admitted using heroin. The use of alcohol and other drugs is associated with a variety of consequences such as violence, motor vehicle injuries, and premature death. Responsible sexual behavior has been identified as a leading health indicator in Healthy People 2010 with specific behavior objectives aimed at increasing the proportion of adolescents who abstain from sexual intercourse or use condoms if sexually active. Adolescents who engage in early sexual behaviors are at an increased risk of sexually transmitted diseases including HIV infection as well as unintended pregnancy. In 1999, estimates were that over half of all high school students had been sexually active. However, national trends showed that between 1991 and 1999, the prevalence of sexual experience among adolescents decreased 8% while the prevalence of multiple partners decreased 13%. Currently, motor vehicle and firearm related injuries are the leading cause of death for adolescents. Between 1996-1997, approximately 14,000 adolescents died annually from injuries, constituting approximately 73% of all deaths among adolescents age 10-19 years. The high death rates from motor vehicle injuries are in part, due to high-risk behaviors among adolescents (e.g., drunken driving, the non-use of seat belts). Motor vehicle death rates were higher for male adolescents, non-Hispanic white, American Indian and Alaskan Native adolescents and lower among non-Hispanic black, Hispanic, Asian and Pacific Islander adolescents. Death rates from firearm injuries increase with age with rates for males 19 years of age or older. Similarly, death rates from firearm injuries for females 19 years of age or older are 10 times higher when compared with firearm death injuries for females age 11. Firearm-related death rates are strikingly higher for Black adolescents when compared to adolescents from other racial/ethnic minority groups. These two leading causes of death are identified as high priority areas in Healthy People 2010. Continued research is needed to decrease the numbers of adolescents engaging in high-risk behaviors, thus reducing and ameliorating the short and long- term consequences associated with these behaviors. Further, many of these behaviors are interrelated and thus may be amenable to interventions that address multiple risk behaviors simultaneously. For example, research has shown that adolescents who engage in heavy drinking may also engage in high- risk sexual behaviors. Thus, targeting both high-risk behaviors in one application may be more successful in improving the overall health profile of adolescents. Research has shown that interventions that target combinations of risk factors may result in more successful and long-term behavioral changes. Objectives and Scope Investigators responding to this announcement are required to target two or more of the high-risk behaviors in a single application. The following are potential areas of research related to this program announcement. These examples are not listed in any priority order and are not to be viewed as exhaustive or an exclusive listing of potential areas. As part of the national efforts to eliminate health disparities, proposals specifically targeting racial/ethnic minority populations are strongly encouraged. NINR"s Strategic Plan on Reducing Health Disparities is located at http://www.ninr.nih.gov. Research targeting other diverse groups of adolescents is also encouraged (e.g., sexual orientation, religious background, single parent families). o Studies investigating the effects and interrelationships among psychosocial and environmental factors (e.g., poverty and the adoption of high-risk behaviors among adolescents). o Intervention studies that elucidate and incorporate the physiological, psychological, socioeconomic, emotional, environmental, cultural, and genetic factors that influence health compromising and or health promoting behaviors among adolescents. o Interventions that incorporate protective factors that aid in preventing adolescents from engaging in multiple risky behaviors. o Intervention studies using peer-based approaches to facilitate health promotion/risk reduction behaviors in adolescents in rural and urban settings. o Innovative intervention studies devoted to enhancing self-efficacy, competence, and skill development to support the initiation and or maintenance of health promoting behaviors. o Culturally and linguistically appropriate studies that incorporate the stages of cognitive development in adolescents of cultural and ethnic background. o Innovative interventions targeting heavy drinking and risky sexual behaviors. o Unique and culturally sensitive interventions to promote healthier dietary intake and adequate activity in minority adolescents. MECHANISM OF SUPPORT This PA will use the NIH R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as non- modular budgeting formats. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, the modular format is required. Otherwise, follow the standard PHS 398 application instructions for detailed budgets. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith based or community based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Janice Phillips Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6152 FAX: (301) 480-8260 Email: janice_Phillips@nih.gov Dr. Vivian B. Faden Chief, Epidemiology Branch Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., MSC 7003 Suite 514 Bethesda, Maryland 20892-7003 (Rockville, Maryland 20852 for Fedex) Telephone: (301) 594-6232 Fax: (301) 443-8614 Email: vfaden@willco.niaaa.nih.gov Dr. Charlotte Pratt National Heart, Lung and Blood Institute Division of Epidemiology and Clinical Applications 6701 Rockledge Drive, Room 8134 MSC 7936 Bethesda, MD 20892 (20817 overnight) Tel.: (301) 435-0382 Fax: (301) 480-1669 Email: prattc@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Ms. Cindy McDermott Office of Grants and Contracts Management National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: cindy_mcdermott@nih.gov Judy Simons Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: judy_simons@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. See http://grants.nih.gov/grants/policy/data_sharing/index.htm for more information. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.361 (NINR), 93.273 (NIAAA), and 93.837 (NHLBI), and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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