THE NEXT GENERATION OF DRUG ABUSE PREVENTION RESEARCH Release Date: December 20, 1999 RFA: DA-00-004 National Institute on Drug Abuse Letter of Intent Receipt Date: February 28, 2000 Application Receipt Date: March 28, 2000 THIS REQUEST FOR APPLICATIONS (RFA) USES THE MODULAR GRANT AND JUST-IN- TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This Request for Applications (RFA) encourages a new generation of drug abuse prevention research. Applications are solicited to examine components of empirically validated drug abuse prevention interventions that may account for program effectiveness. The purpose is to gain a better understanding of what accounts for program effectiveness through: (1) empirical tests of theoretically derived processes that may account for program effectiveness, (2) identification of patterns related to differential effectiveness, (3) generating and testing alternate hypotheses accounting for effectiveness based on differential outcomes from previous research, and (4) specification and testing of components singularly and in combination that contribute to effectiveness. 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 RFA, The Next Generation of Drug Abuse Prevention Research, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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. This RFA invites applications from both investigators with experience in drug abuse research and investigators who have not typically conducted drug abuse research. MECHANISM OF SUPPORT The mechanisms of support will include the investigator-initiated research project grant (R01) and the exploratory/developmental grant (R21). Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information and specific application procedures. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Modular budgeting procedures apply for grants up to $250,000. See http://grants.nih.gov/grants/funding/modular/modular.htm for further information about modular budgets. When applying under the R21 mechanism, the applicant should obtain a copy of the R21 announcement, as it contains instructions for the preparation of the application and other useful information. R21 grants are limited to $100,000 in direct costs per year and to a 3 year effort. The announcement may be obtained from NIDA staff or at http://www.nida.nih.gov/ResFundslist.html. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2000 to fund six to seven new awards in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Over the past 20 years NIDA has supported research on a number of drug abuse prevention programs that have been shown to be efficacious and effective. Primary evidence for efficacy and effectiveness has taken the form of long- term positive results in reducing the onset or progression of drug abuse among intervention compared to control group subjects. To date, demonstrating global results of effectiveness has been the goal of much prevention research. Given the substantial number of empirically supported, theory- based interventions available, the primary evolving questions address which components, strategies, or active ingredients account for program success alone or in interaction with other program components. Specifically, when drug abuse prevention programs work, what accounts for their success? For whom do they work? Under what conditions are they successful? Answers to these questions should be expected to vary depending on the underlying theory, the program’s aims derived from that theory, the program’s content, the implementer, the target population, the delivery, and the interactions among these program aspects. Addressing these questions is a necessary next step for prevention science. Although few studies have focused exclusively on examining success-related drug abuse prevention program components and strategies in any depth, several have studied such factors. These studies suggest that crucial components and strategies include the match between program aims and content delivered, number of sessions provided, the number of sessions attended, the match between the program delivered and the program designed, the use of interactive techniques, and the grouping of clients. Research in other domains suggests that other components may also influence successful outcomes. These include implementer training, goodness of fit between implementer and target population, characteristics of the target population, interpersonal communication styles, and sequence in which content is delivered. Since these findings have emerged from program evaluation studies, few careful descriptions of how program components or strategies contribute to outcomes have emerged. Further, these findings rarely rely on theory-driven analyses. In addition, these studies have not yet tied results back to the theoretical aims that inform the development of program components. Finally, these studies are only beginning to advance new hypotheses aimed at the refinement of underlying theories and program components. In general, the active components and strategies of prevention interventions that account for successful outcomes have been inadequately examined. At least four general areas should be considered in determining what accounts for program success, i.e., content, delivery, implementer, and client. Each area may include active ingredients in the change process intended by the intervention, and both process and outcome research can provide important information. Examples of unanswered research questions related to each of these four areas follow. Content Theories on which prevention programs are based inform the development of program aims. These aims, in turn, are used to develop program content. Because theories are multi-dimensional, most drug abuse prevention programs have multiple content components. In general, multi-component programs have been found to be more effective than single-component programs. However, little research has examined, either prospectively or retrospectively, the effectiveness of content components singularly or in combination. It is possible, for example, that one component of a program may be ineffective in bringing about change when implemented alone, but in combination with another component(s), it may be very effective. It is also possible that several components in combination account for the effectiveness of large multi- component, multi-session interventions. Effectiveness or ineffectiveness could also be related to the sequencing of content components. Some prevention interventions use self-contained sessions or units whereas others use a curriculum approach with each session building on previous sessions. With each of these two approaches it will be important to discover if there are within or across session sequencing effects. Finally, for some drug abuse prevention programs, the question may be whether the content, or something else, accounts for effectiveness. For example, interactions between the target group and the group leader, or among members of the target group, may lead to changes in norms that then influence outcomes independent of content components. Alternately, normative change could result from an interaction between content and environment. Thus, what is effective in one setting may not be effective in another due to differences in either the environment or the target population. Delivery Delivery refers to the methods through which program content is imparted to program clients. Delivery is perhaps the most well studied area with regard to components of drug abuse prevention effectiveness. There is well- documented evidence of effectiveness on components, such as, number of sessions provided, number of sessions attended, booster sessions, and match between program design and program delivered. However, these components have not been well tied to the other component areas of content, client, and implementer. For example, most drug abuse prevention interventions incorporate multi-component delivery systems. Research exploring the differential effectiveness of these modes has found that interactive delivery strategies are more effective than didactic strategies. However, there is little research to suggest why this is the case, which interactive methods are the most effective, and whether there are subgroup differences in delivery mode acceptance and effectiveness. In addition, drug abuse prevention researchers have not yet examined which delivery modes account for the largest effects, whether widely used modes are indeed the most effective for imparting program content, whether the level of exposure interacts with subgroup differences, or whether there is situational specificity in effectiveness. Implementer For drug abuse prevention programming to be maximally useful it must be capable of being delivered by a wide variety of implementers. However, there is wide variation in implementer characteristics that may influence effectiveness. Some intervention studies have examined training, personal and interpersonal characteristics, and fit between target populations and implementers. This research is only beginning to extend to drug abuse prevention. Thus, characteristics related to implementers need to be examined to explore the possibility that the success of some program results are in large part contingent on the qualities of the group leader. Untapped areas of research include identifying overarching qualities of excellent implementers, examining whether excellent implementers are universally acceptable and successful with all targeted groups, and determining what qualities can be taught with lasting effect. Further, characteristics of the implementer may influence the selection of content for delivery. In addition, research in other areas suggests that characteristics such as open interpersonal communication style, receptive body language, ability to empathetically listen, and social reinforcement of pro-social qualities are important characteristics of successful implementers. However, qualities such as these may not affect all members of a target group in the same way. Moreover, there may be bi-directional effects in the implementer individual client process such that those individuals who are experiencing positive changes may be more receptive and motivated. In turn, when particular group members are more receptive and motivated this may make implementers more responsive in general. Client Many prevention models are effective for some populations in some contexts. But what kinds of clients make what kinds of gains in specific program types, and why? Characteristics of individuals and groups can include fixed characteristics, such as gender, receptivity characteristics, such as cognitive and communication styles, and grouping characteristics, such as high-risk behaviors. Theory-based drug abuse prevention programs typically specify target populations based on levels of client characteristics. In general, the universal, selective, or indicated audiences classification is used, with some studies taking a tiered approach in which individuals are moved from universal to selective to indicated based on level of risk or need. Beyond these rather global classifications, little work has focused on targeting prevention content to specific subgroups, and it remains unclear how well client characteristics fit with content, delivery, and implementer components of programs. In some cases, it may be easier to uncover answers to these questions through data on universal interventions in which there is a full range of client types who can be carefully monitored to determine which program components appear to lead to the greatest gains for which subgroups. Recent findings regarding gender differences in program effectiveness underscore both the usefulness of universal level data for examining these issues and the need to develop a better understanding of what subgroup characteristics influence effectiveness. When specific subgroups are selected for inclusion, they tend to be high-risk populations. These groups may offer special opportunities for uncovering client-related programming components because they maximize the potential for detecting interpersonal processes that might account for outcomes. That is, when there is a high density of shared characteristics among member of the intervention group, it may be easier to detect underlying processes that contribute to or detract from program effectiveness. Subgroup analyses can be used to provide feedback for program design and for the development of alternative hypotheses concerning the processes through which program content components may be more or less effective for subgroups. Further, some subgroups may self-select out of particular portions of the intervention. Finally, program content should be examined in terms of whether the client actually learned or mastered the content in the way intended. Barriers and Approaches Moving into the next generation of drug abuse prevention research will be challenging. Tying program aims, content, delivery, client, and implementer components to theory in a way that allows for decomposing theory into testable hypotheses is a difficult task. In this applied area of research, this strategy will result in the ability to test the generated hypotheses and reformulate theory on the basis of the findings from experiments in real- world settings. Challenges exist for accomplishing the drug abuse prevention research that will be necessary to answer questions about components. A number of approaches could be taken in conducting the next generation of prevention research. Data might come from existing longitudinal studies on a single implementation of a given program, from the collapsing of data across multiple replications of the same intervention, or through the conduct of small-scale microanalyses that address a limited number of hypotheses on specific components developed out of prior prevention research. Specific approaches could include dismantling designs, tests of mediational models, or tests of process models. Dismantling designs can be used to systematically add in or take away program components or to determine combinations of components that produce maximum effectiveness for specific subpopulations. Mediational models can use new or existing data to test specific hypotheses generated from the underlying theoretical base. Confirmation and disconfirmation of specific aspects of these models can lead to theory and program refinement. Finally, process evaluations can be used to document and describe important sequences and patterns related to component effectiveness. Despite the challenges inherent in conducting this research, there are important heuristic and practical reasons for moving in this direction at this time. The field of prevention science is ready to enter into a phase of validating existing findings through de-composing the program components that contribute to those findings and, in so doing, build new hypotheses on active program elements. This may set the stage for combining effective components from different interventions to create interventions that target unique community needs. 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 or 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). All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the Federal Register on March 28, 1994 (FR 59 14508- 14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the Web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA’s home page at www.nida.nih.gov/HSGuide.html or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit by February 28, 2000, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. In addition, the letter of intent should identify other key personnel who will be involved in the research and the names of their institutions. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIDA staff to estimate the potential review workload and to plan for the review of the applications. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone (301) 710-0267, E-mail: [email protected]. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total Direct Costs requested for each year. This is not a Form page. Under Personnel, list key project personnel, including their names, percent of effort, and role in the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role in the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications, with full citations. CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title and number of this RFA must be typed in Item 2 on the face page of the application form, and the YES box must be marked. The RFA number must be typed on the label as well. The sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Applications must be received by March 28, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Research (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA. 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 National Advisory Council on Drug Abuse. REVIEW CRITERIA The goals of NIH-supported research are to advance the 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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. (1) Significance: Are the goals and objectives of this application relevant to this RFA? Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? For the R21 mechanism, a strong rationale and conceptual framework are normally sufficient for establishing the feasibility of the project in lieu of extensive preliminary data. This may be true of some R01 applications as well. (3) Innovation: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers, if any? (5) Environment: Does the scientific environment in which the 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: - The adequacy of plans to include both genders, 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 adequacy of plans to make data available to other investigators in a timely fashion. The reasonableness of the proposed budget and duration in relation to the proposed research. - 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. The adequacy of plans for including children as appropriate for the scientific goals of the research. Schedule Letter of Intent: February 28, 2000 Application Receipt Date: March 28, 2000 Council Review: September 2000 Earliest Start Date: September 29, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include scientific merit as determined by peer review, availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elizabeth Robertson, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room. 5160, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-1514 FAX: (301) 443-2636 E-mail: [email protected] Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX : (301) 594-6847 E-mail: [email protected] Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone : (301) 443-2755 FAX: (301) 443-0538 E-mail: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and are administered under PHS grants policies and Federal Regulations 42 CFR 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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