Full Text PA-96-019 INTERVENTION RESEARCH TO PREVENT ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-019 P.T. 34 Keywords: Alcohol/Alcoholism Disease Prevention+ Therapy Evaluation National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and/or testing of interventions that have the potential of preventing alcohol abuse and alcohol-related problems among appropriate target populations. Investigators are encouraged to move beyond preintervention studies into the domain of efficacy and effectiveness studies that directly assess the impact of preventive interventions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Intervention Research to Prevent Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism prevention. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Research Project Grant (R01) applications from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01), First Independent Research Support and Transition (FIRST) Award (R29) or Small Grant (R03). Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. Interactive Research Project Grants require the coordinated submission of related regular research project grant (R01) applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995.Program Project Grants applications (P01) will not be accepted under this program announcement. Investigators who wish to submit an application that exceeds $500,000 for direct costs in any one year must contact program staff before submitting an application. FUNDS AVAILABLE The NIAAA estimates that the average research project grant award size will be approximately $250,000 in total costs per year. Although the financial plans of NIAAA provide for the support of this program, the award of grants pursuant to this announcement is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Intervention and prevention strategies may be initiated and implemented by the investigators themselves for the specific purpose of testing their effects; or the interventions may occur naturally outside the control of the investigator, through actions of public and private organizations. Studies of naturally occurring interventions are called "natural experiments." It may be possible to nest an investigator-initiated intervention within a natural experiment, permitting effects of both types of interventions to be studied simultaneously. Thus, investigators might develop and test an intervention like media advocacy or physician guidance that calls attention to and helps implement a new law or policy for preventing alcohol abuse. Applicants should justify their choice of interventions for study based on relevant theories of behavioral change for individuals or groups and, where possible, on existing data suggesting positive intervention effects. Although natural experiments tend to be empirically-rather than theory-driven, the applicant should still explain why the chosen intervention should (or should not) be expected to have a preventive effect. Applicants may propose small-scale feasibility or pilot studies as a prelude to later designing more complex intervention research. Feasibility studies might address the following types of issues: determining ways to ensure effective recruitment, retention, compliance, and followup of representative study participants (e.g., parents, ethnic minorities, school drop outs); operationalizing interventions for use in real-world environments; determining the acceptability of intervention and data collection protocols by necessary gatekeepers and target groups; developing and testing procedures for training intervention implementors and data collectors; constructing or adapting protocols for use among culturally diverse populations; determining how necessary outcome data can be most effectively, efficiently, and completely collected. Examples of Investigator-Initiated Interventions include, but are not limited to: College-Based Studies: There is a paucity of attempts to develop and test strategies to reduce drinking, binge drinking, and alcohol-related problems on college campuses. Interventions currently being tested include brief motivational counseling and challenging of alcohol expectancies. Applicants are encouraged to expand the breadth of strategies being tested, to focus on high-risk groups, to consider approaches to normative change, and to collaborate with college administrators in designing and implementing prevention policies to be studied. Worksite Studies: Recent preintervention studies of work-related alcohol problems and policies have laid the groundwork for tests of new and modified primary prevention strategies among unionized and nonunionized workers and managers in a range of work settings. Studies of the effectiveness of secondary prevention approaches for early detection of problems and appropriate referral (e.g., through EAPs) are also encouraged. Interventions may attempt to change formal and informal alcohol policies, organizational goals, work environments, work-group norms, and/or perceptions, beliefs, and attitudes of individuals. Family Studies: Data suggest that family involvement can enhance the effectiveness of school-based prevention programs. Moreover, family-focused interventions may themselves reduce alcohol-related problems among youth and adults, including elderly family members. This is an underdeveloped area of alcohol prevention research that needs systematic expansion. Studies may focus on families in general or those at high risk for alcohol problems. Applicants should attempt to develop and test strategies that could ultimately prove to be cost-effective. Labor-intensive interventions should be justified by the magnitude of the problem being prevented. Health-Care Systems: Increasing attention is being given to the possible role of health-care systems and professionals in preventing alcohol-related problems before they occur and in facilitating the early detection of problematic drinking. Experimental and quasi-experimental designs may be used in health-care settings to test the efficacy of preventive strategies. These may include various forms of advice, monitoring, and risk assessment (e.g., anticipatory guidance for teenagers and pregnant women, medication counseling for the elderly). Alcohol and AIDS: Numerous studies have determined that alcohol is an important co-factor in increased risk of HIV infection. Applicants are encouraged to develop and test single or multiple interventions that target populations in which alcohol use or misuse contributes to HIV risk behaviors. These interventions can be aimed at individuals, social networks, and/or social institutions to change alcohol/sexual expectancies, behavioral norms, and risky behaviors. Alcohol-Related Violence: Existing studies show two-way relationships between alcohol use and physical and sexual violence. Research indicates that victims of child abuse are at excess risk of developing alcohol problems later in life and that abusers of alcohol may be at increased risk of perpetrating violence against others. Few attempts have been made to design and test interventions to prevent alcohol- related violence. Such strategies could target potential perpetrators or victims of violence (e.g., partners of alcohol abusers), drinking establishments and hazardous environments (e.g., student vacation sites), or alcohol-availability policies. Alcohol-Related Birth Defects: NIAAA supports a large portfolio of grants concerned with biomedical and epidemiological aspects of fetal alcohol syndrome (FAS) and other alcohol-related birth defects. However, only a small proportion of NIAAA studies have addressed prevention issues. Since fetal alcohol syndrome is the largest preventable cause of mental retardation, there is a compelling need for studies that develop and test interventions that have the potential of reducing rates of FAS among high-risk populations. Heavy-drinking women in the child bearing years are an especially important target group. Genetic/Behavioral Risk Counseling: Vulnerability to alcoholism and alcohol problems reflects a complex interaction of genetic, behavioral, and environmental factors. Mechanisms and modes of inheritance may differ for various subtypes of the illness or condition. The time has come to explore the possible benefits of counseling for high-risk families that takes into account aggregate familial risk factors including genetics. Such interventions should: be developmentally age appropriate, address the initiation and progression of drinking, deal with mediating behavioral processes and family dynamics, and avoid misattribution, labeling, and stigmatization. Outcome measures could assess changes in risk perceptions, attitudes, and behaviors of target individuals and families. Media/Communication Strategies: Previous research suggests that media interventions alone are relatively weak prevention strategies, but they clearly can be an important adjunct to other community initiatives such as road blocks and zero tolerance BAC laws. Ongoing research is assessing the utility of communication strategies in preventing alcohol problems among youth. Applicants are encouraged to develop and test promising messages, communication technologies, persuasive styles, and formats to determine the most efficacious and effective media/communication approaches for varied target groups. Special Populations: There is a critical need for preventive intervention research that focuses on understudied populations including racial/ethnic subpopulations, rural populations, older Americans, disabled persons, heavy-drinking women in the child bearing years, and lesbians. Preintervention studies among these groups have identified risk and protective factors for alcohol abuse, populations at excess risk, etiologic processes, and potentially effective prevention strategies. However, very few studies have actually tested the impact of preventive interventions among these populations. Natural Experiments Naturally occurring preventive interventions are being implemented by Federal, State, and local governments, educational institutions, and the private sector to address such problems as drinking and driving, underage drinking, alcohol-related violence, worksite alcohol abuse, fetal alcohol syndrome, and sexual risk-taking. Policy-driven strategies have proven highly effective in reducing alcohol consumption and attendant problems. Examples include increasing the legal minimum drinking age, lowering legal blood alcohol levels for drivers, administrative license revocation, and higher taxes on alcoholic beverages (generally implemented for revenue rather than prevention purposes). Naturally occurring multidimensional community prevention programs have also shown positive results. Natural experiments have both advantages and disadvantages. In their favor: they take place in real-world settings where generalizations to analogous populations are highly plausible; the interventions do not have to be subsidized by the research project; where government bodies initiate the interventions study results are likely to be policy relevant, indicating whether the strategies are worthy of diffusion and how they could be improved; and established methods (such as time series analysis) exist to assess the impact of natural interventions. On the negative side: naturally occurring interventions rarely permit efficacy studies where strategies being evaluated are implemented under optimal conditions. Nor is it generally possible to conduct randomized controlled trials. Effectiveness studies based on quasi-experimental designs are usually the only option. Time pressures may also negate or limit collection of pristine baseline data before the intervention is implemented; acceptance of the intervention and the quality of its implementation may vary across sites; and identification of appropriate control or comparison groups can be difficult, particularly for universal interventions. In selecting natural interventions for possible study, applicants should consider: the state of the science on that issue, the generalizability of research findings, whether a methodologically sound study can be launched, potential cooperation with the initiating body (including possible co-funding), types of pre and post outcome data available or collectable over the proposed time period, relevant target groups, and the appropriateness of subgroup analyses (e.g., by gender, ethnicity, and age). Researchers are also encouraged to collect prospective and retrospective process data (qualitative and quantitative) to shed light on causal linkages between interventions and outcomes. Current naturally occurring interventions of interest for research include: strategies to reduce drunk driving such as per se laws, interlock devices, vehicle impoundment, combinations of jail and other sentences, victim impact panels, and special licensing procedures for youth; controls on youth access to alcohol such as keg registration, increased law enforcement, and constraints on false identification; server training programs; college and school-based strategies that implement legislative and administrative policies; constraints on alcohol availability (e.g., at sports events); dram shop liability laws; constraints on alcohol advertising and promotions; health promotion and moderate drinking messages by advocacy groups and the alcohol industry; zoning controls on location and density of alcohol outlets; and other community-initiated prevention programs. Natural interventions that have implications for alcohol-problem prevalence are important to study even if prevention is not a stated goal (e.g., alcohol taxes or privatization of outlets). The NIAAA recognizes that Government and private initiatives to prevent alcohol problems are continually being implemented. Where grant review and funding schedules would seriously delay the proposed research, applicants should discuss these timing problems with the listed program administrator. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, National Institutes of Health, 6701 Rockledge Drive, MSC 7910 Bethesda, MD 20892-7910, telephone: 301-710-0267, email girg@drgpo.drg.nih.gov. The title and number of the program announcement must be typed in section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Small Grants do not receive a second level review by a national advisory council. Review Criteria Criteria to be used in the scientific and technical merit review of research grant (R01) applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research and the feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, and/or availability and quality of necessary data). 5. The appropriateness of budget estimates and duration in relation to the proposed research. 6. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement (revised February 1994). The review criteria for Small Grants (R03) are contained in the Small Grants program announcement for NIAAA PA-91-08 dated October, 1990. AWARD CRITERIA Applications recommended for approval will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Potential applicants may obtain copies of specific specific announcements from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20852, telephone: 301-468-2600 or 1-800-729-6686. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed under INQUIRIES. Direct inquiries regarding potential research to: Capt. Patricia Mail Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8744 or 443-1677 FAX: (301) 443-8774 Email: pmail@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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