Full Text PA-96-018 DRUG ABUSE PREVENTION INTERVENTION FOR WOMEN AND MINORITIES NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-018 P.T. 34, FF, II Keywords: Drugs/Drug Abuse Disease Prevention+ Risk Factors/Analysis National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to advance research to develop, refine, and test the efficacy and effectiveness of theory-based, universal, selective, and indicated drug abuse prevention interventions for minorities and women. These interventions should combine what is known from drug abuse prevention research with what is known, in particular, about culturally diverse and/or gender specific experiences. This scientific research initiative will seek to identify risk and protective factors that may be associated with core cultural and/or gender value systems and life experiences in order to design and test under controlled conditions comprehensive, theory-based preventive interventions that are sensitive to cultural and/or gender norms or needs. It is imperative that ethnic and/or gender status be treated as an explanatory variable and not just a descriptive one; that is, there must be a theoretical basis offered that lends guidance to the intervention designed and that will allow for discussions of outcomes in a manner that contributes to a detailed scientific understanding of prevention theory and program priorities that best meet the unique needs of minority sub-populations and women. 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 PA, Drug Abuse Prevention Intervention for Women and Minorities, is related to the priority area of alcohol and other drugs. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award. Because the type and scope of proposed research responsive to this PA may vary, it is anticipated that the size and period of the award will vary also. RESEARCH OBJECTIVES Background A major priority of the National Institute on Drug Abuse (NIDA) is to gather and expand the use of scientific information concerning the prevention of drug abuse and addiction that could lead to HIV infection and AIDS. NIDA support of such research rests on a general assumption that the negative consequences of drug abuse may have differential impact and may require targeted prevention intervention strategies for some of the population groups found within the United States. Although NIDA encourages research on the extent and nature of drug abuse among underserved groups, no existing research grant program addresses the unique risk and protective factors of specific underserved populations. Thus, the purpose of this program announcement is to develop, implement, refine, and test the efficacy and effectiveness of theory-based, comprehensive drug abuse prevention intervention models for minority populations and women. A gestalt position that has been embraced by many is that America is an umbrella social system where cultures and traditions blend into one all inclusive community, reflective of common goals, opportunities and experiences. While the various racial/ethnic groups in the United States may share a common culture with many similarities in areas such as values, spirituality, family functioning, and language, there are important sociodemographic differences, (e.g., country of origin, level of education, and acculturation level) which may explain why a consensus model of ethnic and cultural melding has remained theoretical and underdeveloped. To advance the field of prevention, researchers must first acknowledge and then accept that groups have retained their own value, belief, and behavior systems and that the cultural diversity within these groups has been generally overlooked. When classifying ethnic minority status, four general population categories have traditionally been defined as: (1) Blacks or African American; (2) Hispanics; (3) Native Americans or American Indians; (4) Asians or Pacific Islanders. This simplified division has produced epidemiologic and etiologic data delineating major sociodemographic differences across these communities and have enabled researchers to study each population as if it was an unvarying, cohesive whole -- a distinct culture. However, nested within each group are a variety of cultural variations, traditions and styles that are as distinct and different as constructs measured across populations. As such, there is no Black or African American community; there are individuals who are descendants of American slaves, foreign born blacks, and individuals that are racially mixed. The Hispanic group includes Puerto Ricans, Mexican Americans, Cubans, Central and Latin Americans, and individuals from Spain. Likewise, the Native-American group is not one homogenous community; there are a variety of Southwestern tribes, Northern Plains tribes, Eastern Woodlands and Pacific Northwestern groups. The most complex, and the least studied, is the Asian and Pacific Islander populations which consists of individuals from 26 countries/island groups and who have the fastest growth rate (82 percent) of any group in the 1980s. Prevention intervention research needs to address diverse culturally relevant contexts and drug abuse etiologies. For example, population studies indicate that American Indians, particularly those on reservations, have the highest rates of drug abuse compared with any other minority group. Is this statistic a commonality across all American Indians or is it specific to the Southwestern tribes? What are the implications for the design and testing of prevention interventions? Research focused on the role of acculturation suggests that Puerto Rican youth who identified less with Puerto Rican cultural values were more likely to abuse drugs than those who were more identified. Is acculturation strain equivocal across Hispanic groups (e.g., Mexican Americans) and does it impact on initiation of drug abuse to the same extent? What prevention interventions could be developed and tested to address social adaptation issues? Data show that African-Americans are more likely to use drugs intravenously. Is this pattern consistent for foreign born as well as American born Blacks? What are the key factors promoting IV drug abuse and are these factors amenable to change through prevention interventions? Attitudes regarding health and addiction within the Asian and Pacific Islander groups also vary greatly. For example, Samoans do not view drug abuse as an addiction but, rather, as an episodic mistake in the judgement of the user. This interpretation of the nature of addiction is incompatible with the beliefs of other Asian cultures who consider drug abuse as an imbalance in spiritual matters. To what extent can prevention interventions address drug related belief structures that are indigenous to a culture? Notwithstanding some shared, basic underlying cultural similarities across minority groups, their very real within group differences (e.g., rituals, values, attitudes, etc) make it critical to fine tune existing prevention intervention research efforts. There is a scarcity of prevention intervention research that addresses the unique set of physical, biological, social and psychological problems that are specific to women (the term woman is used to refer to females of all ages. Elsewhere, where appropriate, the terms 'girls' and 'adolescent females' are used). Although females comprise 51 percent of the population, they have been neglected in this field of research, and therefore, unserved as a group distinct from males. Gender differences in the epidemiology of drug abuse are quite apparent, with the number of male drug abusers and addicts exceeding that of females. The consequences of drug abuse by women, however, are more severe and data indicate that after initial use women may proceed more rapidly to drug abuse than men. The causes, correlates and consequences of drug abuse and addiction appear also to differ with respect to men and women. For women, for example, a fairly high correlation appears to exist between eating disorder and substance abuse. Preliminary data from NIDA research indicates that the more severely a woman diets and engages in binge eating the more likely she is to experience negative consequences from drinking alcohol, and the more likely she is to meet the criteria for substance abuse or dependence. Women's initiation into drug use also differs from that of men's. Preliminary results from a study on gender differences in cocaine initiation and abuse indicate that approximately 90 percent of women reported that men played some role in their involvement with crack cocaine. By contrast, only 17 percent of men reported that women were involved in their initiating or maintaining the use of crack cocaine. Women were more likely to begin or maintain cocaine use in order to develop more intimate relationships, while men were more likely to use the drug with male friends and in relation to the drug trade. With regard to antecedent conditions, while conduct disorders and other observable behaviors signal risk for males, the etiology of female drug abuse appears to lie in predisposing psychiatric disorders prior to abusing drugs. Preliminary data from studies of antecedents of crack cocaine abuse among African American women found preexisting psychiatric problems to be a major cofactor. Specifically, there was a strong correlation between the age of first drug use and the first depressive episode. Additionally, these women had conflicting relationships with, and less attachment to, their mothers. Women who have been victims of crime, likewise, appear to have increased vulnerability to substance abuse. Research conducted among a population of women in residential or outpatient drug treatment programs found that 80 percent had been crime victims. Additionally, female crime victims were more likely to have major drug and alcohol problems than nonvictims. Female crime victims who suffered from Post Traumatic Stress Disorder (PTSD) were almost 10 times more likely to have major alcohol problems and 17 times more likely to have major drug abuse problems than nonvictims. Numerous studies have shown PTSD to be a strong predictor of substance abuse. Many questions remain to be addressed regarding prevention intervention activities for females. For example, to what extent does initiation of drug use and progression from use to abuse and dependence differ for females when compared to males? To what degree this occurs, will provide important information which needs to be incorporated in targeted drug prevention intervention efforts. Different types of 'victimization' (e.g., sexual abuse, physical abuse, being the daughter of a drug abusing mother and/or father, etc.) create different patterns of subsequent drug abuse. How should prevention interventions differ as a function of this? Does the descent from various ethnic cultures promote specific native gender roles and to what extent are these congruent, complementary, or in conflict with society, at large? The scientific answers to these and many other questions are necessary to advance prevention intervention activities. Research Goals and Issues NIDA encourages research applications that test the efficacy and effectiveness of theory-based preventive interventions at the universal, selective, and indicated level. NIDA will also commit to investigating the relationship between the intrapersonal, interpersonal, familial, cultural community roles, and other larger societal factors upon the prevention of drug abuse among minorities and other underserved populations. This scientific research initiative seeks to identify risk and protective factors in order to design and test comprehensive, theory based preventive interventions that are sensitive to cultural norms and responsive to community needs. Prevention intervention research should focus upon the strengths of cultural systems as experienced and promulgated by the family and community. For example, research is needed to know how positive family sanctions and strong religious values may protect culturally diverse youth from drugs of abuse during their early school years. Prevention intervention research is needed to know how family values and community networks of friends, volunteers, and relatives interact. Research is needed to design and test promising drug prevention programs that build upon the cultural, social, family, and religious values that appear to protect or inoculate many culturally diverse youth from drug abuse and HIV/AIDS. Prevention intervention strategies for these groups should entail a comprehensive approach to their needs at the Universal, Selective and Indicated levels. Specifically, Universal prevention interventions are targeted to the general public or a whole population group that has not been identified on the basis of individual risk or resilience status. Selective prevention interventions are targeted to individuals or a subgroup of the population with well defined risk factors within their life profiles and whose risk to resilience status to developing substance abuse disorders is significantly higher than average. Indicated preventive interventions are targeted to individuals or subgroups who are identified as having minimal but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction, or with biological markers indicating predisposition for substance use disorders AND who have not met diagnostic levels according to DSM-IIIR or DSM-IV. For strategies to be potentially effective and interpretable, they must be guided by theory, take advantage of the cumulative progress in the field, and must target ethnic minority youth and young adults and/or women. How mechanisms of predisposition and/or protection are affected by intervention and how this is linked to outcome needs to be explored. Investigators should pay careful attention to operationalizing definitions and defining the independent variable that describe the intervention processes. Especially encouraged is research that investigates resiliency and other protective factors among underserved populations and women who may otherwise be at risk of abusing drugs but do not. Studies that aid in the development of methodologies which can lead to the early identification of those at risk for drug abuse and HIV/AIDS among the various ethnic/racial groups and females are particularly encouraged. All applicants are urged to address issues of project feasibility and collaborative arrangements at the community level. The research proposal should include a randomized or well-controlled quasi-experimental study design, as well as state of the art sampling procedures, instrumentation and measurement, data collection, quality control, client tracking and follow-up, and data analysis. It is essential that applicants discuss potential barriers to implementing this type of study as well as strategies to deal with relevant issues. Particularly critical to discuss are issues related to community collaboration, confidentiality, anticipated staff, and further types of sub-studies. Power analyses must be included to support proposed cell sizes of the research design and overall number of study participants. Tests to determine the potential effects of differential attrition should be included. Finally, state of the art econometric techniques for measuring the cost-benefit or cost-effectiveness of prevention interventions should be included in the proposed research. NIDA will accept prevention intervention research applications that: o Demonstrates knowledge of the culture, diversity and potential predispositions to risk behaviors and relevant risk/protective factors of minority populations and/or women and applies this knowledge to the proposed prevention research at the conceptual, design, and analyses level. Limitations pertaining to the adequacy to which culture and diversity are addressed should be identified. o Demonstrates familiarity with the approaches and problems associated with working with underserved populations. Knowledge of previous prevention intervention research, theories, methods, and measures is essential. Challenges from a specified problem or approach must be identified and solutions proposed. o Advances theoretical development by incorporating aspects of culture and risk/protective factors in the conceptual base used for the proposed prevention intervention(s). o Establishes working relationships with minority communities and professionals. o When appropriate, assessment of gender differences is encouraged. o Demonstrates focus on theory-based preventive intervention efforts that will address salient risk and protective factors specific to culturally diverse and ethnic minority sub-populations as well as women. Addresses questions pertaining to the fit or match of specific prevention approaches to the diversity of the underserved population under investigation. Prevention intervention strategies may demonstrate differential effects within various ethnic groups and socioeconomic populations. Multiple intervention strategies may be needed to deter and delay the initiation of drug use behavior and to impede progression to drug dependency and associated social, psychological, and physiological sequelae. o Demonstrates attention to the design and testing of theory- based prevention programs focused upon the prevention of the precursors to the drug abuse problem, such as early signs of aggression, violence, problems with interpersonal relationships, oppositional behavior, and changing risk factors to abuse that may emerge after drug use has been initiated. o Conducts and rigorously tests culturally sensitive drug abuse prevention intervention efforts previously developed but not empirically tested. o Proposes a randomized or well-controlled quasi-experimental research design, a technically sound measurement model that employees culturally relevant instruments, and advanced statistical procedures for hypotheses testing. o The dual epidemics of drug abuse and HIV infection have significantly heightened the urgency of developing effective prevention activities which target HIV risk behaviors. Drug abuse-related HIV transmission occurs through the sharing of contaminated injection equipment and high risk sexual behaviors (e.g., unprotected sex with multiple partners). Researchers are encouarged to specifically address these behaviors in the design and research of interventions. 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 28, 1994 (FR 59 14508-14513), 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. Confidentiality. The PHS has a formal policy concerning Certificates of Confidentiality and communicable disease reporting. In brief, the policy reflects the expectation that research projects will cooperate with State and local health departments to assure that the purposes of reporting are accomplished, and the expectation that health departments will develop relationships with research projects that assist their mission without thwarting the research goals. A description of the policy as well as Instructions for Applicants can be obtained after award. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: [email protected]. The title and number of this PA must be typed in Item 2 on the face page of the application. The completed original 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 (for courier/overnight 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 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 on board. Review Criteria o scientific or technical significance and originality of the proposed research; o appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff; o availability of resources necessary to the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o 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 and animal subjects, and safety of the research environment. AWARD CRITERIA Applicants will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ro Nemeth-Coslett, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-1514 Email: [email protected] Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are authorized under the Public Health Service Act, Section 301 and administered under PHS policies and Federal Regulations CFR 52 and 45 CFR Part 74. "Confidentiality of Alcohol and Drug Abuse Patient Records" may be applicable to these awards. Program is not subject to the inter-governmental review requirements of Executive Order 12372. 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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