SCHOOL-BASED PREVENTION INTERVENTION RESEARCH NIH GUIDE, Volume 23, Number 16, April 29, 1994 PA NUMBER: PA-94-061 P.T. Keywords: National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage the scientific study of drug abuse prevention strategies that are based in the school environment to determine their efficacy in preventing the initiation of drug use and dependent patterns of drug abuse. Two major types of research are included under this program announcement: new innovative, theory-based school-based programs/curricula; and, the evaluation of existing school-based programs/curricula that have been well-established within schools for a number of years. Research must include both process and controlled outcome studies and must examine the relationship between process and outcome. Where possible, impact measures should be included. Process studies examine the extent to which the program has been implemented as designed. Outcome studies assess the extent to which the programs have achieved their desired effects. These studies should focus not only on drug use behaviors but also on those behavioral, attitudinal, cognitive, and environmental factors that are to be influenced by the intervention. Finally, impact studies analyze the extent to which the programs have altered drug use practices at the school, neighborhood or community level. Follow-up analyses should emphasize the relationship between the mediating variables and drug usage patterns. Studies focused upon rural and inner city schools are encouraged. HEALTH 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, School-based Prevention Intervention Research, is related to the priority area of alcohol and other drug abuse. 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 foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, research institutions, units of State or local governments, and eligible agencies of the Federal government. Applicants from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) Awards. MECHANISMS OF SUPPORT Support mechanisms include research projects grants (R01), small grants (R03), FIRST awards (R29), and program projects (P01). Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will also vary. RESEARCH OBJECTIVES The goal of this program announcement is to invite applications from researchers who wish to study the efficacy and effectiveness of school-based interventions. The specific objectives of this research program are to promote research studies that examine the relationship between theory-based prevention intervention strategies and drug using behaviors with special emphasis on delineating the effects of these interventions on one or more of the following domains: cognitive, affective/interpersonal, behavioral, environmental/policy, and therapeutic as discussed below. Cognitive preventive strategies focus primarily on increasing the target population's knowledge of the pharmacologic effects and physical/social consequences of drug use and abuse, and on establishing attitudes and belief structures that are supportive of a drug-free lifestyle. Prevention strategies that include affective and interpersonal factors attempt to strengthen children's inner emotional and psychological resources by improving feelings of self-concept and self-worth and by assisting children to become more aware of their own feelings and those of others. Although these intervention strategies may not directly target drug using behaviors per se, their underlying premise is that by focusing on children's psychological development, the potential for involvement with drugs will be minimized. The foundation of behavioral intervention strategies are the philosophy and tools of behavioral therapy. Through these interventions children are taught resistance scenarios and skills to prevent involvement in drug using behaviors. Six steps usually form the program: instruction and coaching in resistance techniques, modeling of the desired behaviors by peers, guided practice and role playing, feedback from peers and instructors, social reinforcement through praise, and training for generalization of the new skill to the children's natural environment. Environmental/policy strategies include school management activities to deal with student drug problems. These would include the implementation of school drug policies, drug-free school zones, and may involve parents and community agencies such as the police department. The impact on drug abuse and related behaviors of recent efforts to re-tool school environments (for example, by involving parents in classrooms, by increasing the use of schools for non-academic activities, and by encouraging supportive interactions among students about academic and non-academic problems) could also be studied. Finally, therapeutic strategies are designed for children who are already experiencing adjustment problems in school, the family, and, the community. These programs focus on early identification and referral and may also include alternative day school learning environments. The purpose of these programs is to keep children in school as long as possible while at the same time providing needed therapy in the form of special educational modules and individual and group counselling. A variety of techniques should be employed to realize the aims of these intervention approaches including peer group discussions, special classroom activities, dissemination of policy guidelines, special parent and community organizations, and, individual and group counselling. Both the intensity and methods of these interventions need to be evaluated with respect to immediate effectiveness in intervening factors (cognitive, behavioral, affective/interpersonal, environmental/policy and therapeutic) and to long-term drug using behaviors. Further study is needed to identify and determine the effects of risk and protective factors. Studies that assess long-term effects need to be carried out. The relationship between process and outcome requires examination. The effect of various strategies in combination with other strategies needs additional investigation. Health Services Research Research specifically targeted toward determining the effectiveness of school-based drug prevention programs as part of the health care services system is encouraged. These studies should assess the effectiveness of drug prevention programs under real world conditions. Prevention Research in Rural Communities Drug prevention research within rural communities is encouraged. Studies are needed to determine the efficacy and effectiveness of drug prevention programs uniquely suited to the needs of youth and young adults living in rural America. Research should ultimately address these questions: o what is the validity of the theoretical basis of the intervention? o does the intervention achieve the desired effects? o to what extent are these effects achieved? o for whom is the intervention most effective? o what process factors are associated with positive outcomes? o what is the cost effectiveness/cost benefit of the intervention? Application characteristics should include: o Specification of a theoretical or conceptual framework for the intervention and associated hypotheses o Specification of the intervention strategy being studied o Involvement of some community segment or agency as part of the intervention o Specification of target populations and intent of the intervention, e.g., knowledge, resistance skills, improved academic competence, measures of increased school/family/community bonding o Clarity as to the sampling unit and unit of analysis o Experimental or quasi-experimental research designs o Specification of period of follow-up both of the intervention and of the data collection effort o Identification of tracking and follow-up into the "at risk" years, i.e., late adolescence, early adulthood STUDY POPULATIONS 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 new 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 9, 1994 (FR 59 11146- 11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. 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. 9/91) and will be accepted at the standard application deadlines indicated in the application kit. Receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of this program announcement must be typed in Item 2a on the face page of the application form PHS 398. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Other NIDA program announcements may be obtained from the Grants Management Branch, National Institute on Drug Abuse, 5600 Fishers Lane, Room 8A54, Rockville, MD 20857, telephone 301/443-6710. The completed original and five legible copies of the application form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by initial review groups in accordance with the standard NIH peer review procedures. Following the scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Small grant applications (R03) do not receive a second-level review. AWARD CRITERIA Applications will compete for available funds with all other applications assigned to the NIDA. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Larry A. Seitz, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse Parklawn Building, Room 9A53 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1514 Direct inquiries regarding fiscal matters to: Gary P. Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," Title 45 CFR part 74 & 92, "Administration of Grants," and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2 "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Awards must be administered in accordance with the PHS Grants Policy Statement (rev. 10/90), which may be available from your office of sponsored research. .
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