Full Text PA-97-005 RESEARCH ON ADOLESCENT DRUG ABUSE NIH GUIDE, Volume 25, Number 37, November 1, 1996 PA NUMBER: PA-97-005 P.T. 34, AA Keywords: Drugs/Drug Abuse National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) is firmly committed to support of research in the area of adolescent drug abuse. The purpose of this program announcement (PA) is to encourage further investigations in this area, particularly with regard to gaps in current knowledge. 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, Research on Adolescent Drug Abuse, 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 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 institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT Mechanisms available for support of this program announcement are the research project grant (R01), the small grant (R03), and the FIRST award (R29). 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 vary also. RESEARCH OBJECTIVES Background Recently released data from the 1995 Monitoring the Future Study and the 1995 National Household Survey on Drug Abuse indicate drug use among youths has increased and the age at which drug use begins has declined. Additionally, among those surveyed there was a decrease in perceived risk-of-harm in using drugs and an increase in the perception that illicit drugs were easy to obtain. Although tobacco, alcohol, and marijuana were the substances most tried, the use of heroin, cocaine, amphetamine and inhalants was also on the rise, as was LSD and other hallucinogens (e.g., MDMA/ecstasy) among a growing number of adolescents who participate in the Rave scene. Studies have examined a wide range of variables, from biogenetic factors to purported macro-environmental influences, to determine what makes one adolescent and not another more vulnerable to initial and continued drug use. Research findings suggest that no one factor accounts for all known causes, consequences, and patterns of drug use. Rather, interacting biological (e.g., genetic influences), psychological (e.g., depression; learning problems), social (e.g., family instability; sexual/physical abuse; gang membership), and environmental (e.g., street violence; neighborhood drug trafficking; poverty) factors appear to put adolescents at risk. Consequently, multiple factors have been considered when interventions were developed that aimed at preventing initial exposure or further escalation of drug use in a teenage population, or at treating adolescents already affected by drug abuse. In terms of prevention, a number of effective universal-level programs have been developed that target adolescents sharing a general risk of drug use. Examples are found in drug-free schools and the national media. Effective selective-level programs, by contrast, have been designed for specific adolescent subgroups demonstrating one or more of the well defined risks or predispositional factors associated with later drug use. Community-sponsored activities such as the big brother/sister organizations are examples. At the indicated-level of prevention intervention, studies have examined programs that target adolescents identified as currently having minimal but detectable signs and symptoms that foreshadow drug abuse and addiction. Although most of these programs have focused on school truants and dropouts, future research is needed to develop effective interventions for the increasing number of drug-using adolescents identified in job corps training and juvenile-court detention programs. Unlike drug prevention efforts, treatment for drug abuse and addiction traditionally has focused on adult-age clients. With the exception of family-based therapy for adolescents, few programs admitted persons under 18 years of age. When they did, components of the program (e.g., methadone maintenance; individual counseling) were based on therapeutic models appropriate for adult addicts. Rarely were human developmental differences identified, then examined in terms of how they might enhance or adversely affect the process or outcome of treatment. Recently, however, a number of modified adult programs (e.g., adolescent therapeutic community) and innovative adolescent-focused behavioral strategies (e.g., life skills training) have been developed, assessed and found to be effective for reducing, but not eliminating drug use. Moderate progress has also been made in developing and assessing behavioral strategies to engage adolescents and their parents in treatment process. Given the increased number of young persons environmentally exposed to and/or directly involved in using drugs, there is currently insufficient scientific knowledge about therapeutic interventions which are cost-effective in treating drug abusing youths in a variety of settings (e.g., outpatient clinic; residential hospital; primary care office practice) or efficacious in treating adolescents with special needs, including those who are runaways or homeless, incarcerated or on probation, gang members, pregnant or parenting, gay or lesbian, HIV positive or diagnosed with a comorbid mental disorder. In addition, more must be learned about drug treatment access, availability and utilization, as well as methods to establish and maintain effective linkages among drug prevention and treatment programs, other health and social services, public education and juvenile justice. Based on the many important developmental differences between adolescents and adults that have been identified in terms of drug use patterns, prevention and treatment, considerable progress has been made over the past decade in developing valid and reliable screening, diagnostic, and survey tools appropriate for use with English speaking youth. Because less attention has been given to gender-, age-, and cultural specificity or to the multiple concomitant problems experienced by drug-involved youths, more studies are required to provide the field with the necessary assessment tools for research and practice. Research Areas of Interest This Program Announcement encourages submission of proposals to study the many remaining issues that relate to adolescent drug abuse. Research topics of interest include, but are not limited to, the following: o Relationship of adolescent drug use initiation, escalation, dependence, withdrawal and relapse to potential acute, intermediate and long-term neurotoxicity, neurological disease and cognitive deficits. o Relationship among adolescent drug use patterns, high HIV-risk sexual behaviors and the adolescent's exposure to drug abuse and violence in the family, peer group and community environment. o Gender- age-, and culture-related differences in the progression, initiation to, antecedents and consequences of, and preventive and therapeutic interventions for drug use, abuse, and dependency. o Personal, social, and environmental resiliency- and protective-factors as they relate to adolescent drug use and addiction. o Language-of-origin, acculturation, assimilation, cultural beliefs and traditional practices, alone or in combination as they affect the outcome of prevention and treatment. o Effectiveness of theory-based, developmentally sensitive, drug abuse prevention programs designed specifically for younger or for older adolescents. o Efficacy of individual, peer group and family behavioral therapies, or combined behavioral- and pharmacotherapies, when delivered in more versus least restrictive environments, designed solely for adolescents or for both youths and adults. o Efficacy of pre-treatment engagement strategies and orientation programs to increase retention in treatment, and post-treatment interventions to prevent relapse to drug use. o Impact of financing on service utilization and cost-effectiveness of adolescent drug treatment programs delivered in settings such as a residential therapeutic community, hospital inpatient ward, outpatient clinic, or integrated into primary care office practice, school-based and juvenile court programs, or social service agencies. o Psychological, familial, social, and environmental factors that affect adolescents' perception and natural history of drug use, unsafe sex, and other HIV-risk behaviors. o Innovative behavioral therapy approaches or multi-component community-based programs aimed at preventing adolescent drug use and other HIV-risk behaviors. o Availability, accessibility, and linkages between drug abuse treatment and related services as they may affect the adolescent's compliance with prescribed psychosocial and pharmacological treatment for HIV/AIDS. o Validity, reliability, and normative data on culture-, gender- and age-specific adolescent subgroups for currently available or newly developed drug-related survey, screening, diagnostic, and motivation-for-treatment assessment instruments. Where appropriate, investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. In high risk populations, investigators are encouraged to assess the effects of new interventions on the acquisition and transmission of HIV. A focus on the provision, organization, and management of HIV/AIDS-related services such as testing and counseling, and services to groups at high risk for HIV/AIDS is encouraged. Applicants are advised to review the existing literature on adolescent drug use and abuse. Applications should reflect appropriate research paradigms, and use most rigorous methodological and analytic designs that are feasible, given the primary research question of interest. Timely reporting of findings is emphasized. Applicants should be willing to participate in research coordination efforts to maximize the utility of the research, including review and dissemination activities. For information on other research topics related to adolescent drug abuse, applicants are encouraged to request copies of program announcements "School-based Prevention Intervention Research" (PA-94-061), "Comprehensive Prevention Research in Drug Abuse" (PA-94-056), and "Drug Abuse Prevention Through Family Intervention" (PA-96-013). 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, Volume 23, Number 11, March 18, 1994. 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. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 (rev. 5/95) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, 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 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 (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The completed original application and five legible copies of the PHS 398 form 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 to an appropriate peer review group convened in accordance with the standard 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. R03 applications do not undergo a second-level review. Review Criteria o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; 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 the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of 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: Elizabeth Rahdert, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: [email protected] Direct inquires regarding fiscal issues 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 made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects". This program is not subject to the 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, (revised 4/94), which may be available from your office of sponsored research. 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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