IMPROVING BEHAVIORAL HEALTH SERVICES AND TREATMENT FOR ADOLESCENT DRUG ABUSE RELEASE DATE: December 9, 2002 RFA: DA-03-003 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: March 14, 2003 APPLICATION RECEIPT DATE: April 14, 2003 THIS REQUEST FOR APPLICAIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THE RFA The National Institute on Drug Abuse invites grant applications for the conduct of behavioral health services and treatment research on adolescent drug abuse. This Request for Applications (RFA) strives to build on recent studies of drug abuse treatment for adolescents to improve and expand the delivery of efficacious treatments to drug abusing youth. Thus, applications are encouraged that (1) investigate ways to broaden youth access to treatment services; (2) examine improvements in treatment delivery, including breadth, integration, and targeting of services for adolescents at different developmental stages in both their own maturation and their drug use and treatment careers; (3) develop, modify, or test behavioral treatments, or combined behavioral and pharmacological treatments, targeting adolescent drug abusers; and (4) analyze strategies for translating efficacious clinical treatments into effective community interventions. RESEARCH OBJECTIVES Background Adolescent drug abuse continues to be a major public health concern. In recent years, this concern has triggered a spate of research on drug abuse treatment for adolescents, with promising results. Outcome studies have identified several treatments—including family-focused interventions, cognitive-behavioral strategies, contingency-management approaches, and therapeutic communities—that are efficacious in reducing drug use, criminal activity, family problems, and other risky behaviors in adolescents and in improving school and job functioning (Azrin, McMahon, et al., 1994; Hser, Grella, et al., 2001; Williams & Chang, 2000). These research advances notwithstanding, far too few communities provide sufficient treatment services for adolescents. Only about ten percent of adolescents who need substance abuse treatment currently receive it, and of those who do receive treatment, only about one-quarter receive enough (Substance Abuse and Mental Health Services Administration [SAMHSA], 2001). Underlying this nationwide deficit are misunderstandings about the nature of drug abuse and the unique needs of adolescent drug abusers. Other contributing factors include a growing but still small number of treatment models, limited access to intervention services, restricted breadth of services and inadequate means for targeting them, and limited translation of efficacious clinical treatments into effective community interventions. Nature of adolescent drug use and abuse. Not all adolescents who use drugs will develop behaviors and symptoms severe enough to diagnose as drug abuse or dependence, but drug use during adolescence may nonetheless interfere with healthy development. For adolescents whose drug use escalates to abuse, the traditional "acute care" model of drug abuse treatment and recovery may no longer be adequate. Rather, drug abuse researchers and clinicians describe a complex picture of recurring cycles involving drug use initiation, escalation to abuse, health services intervention, remission, lapse, and relapse. Once adolescents are diagnosed with a drug abuse disorder, several full cycles spanning many years may be the norm for drug treatment rather than the exception. Emerging work on the nature and course of drug abuse, alone and in combination with other mental and physical health problems, has implications for revising current intervention paradigms, amending conceptualizations of the effectiveness of treatment services, improving the organization and delivery of services, and planning for and appraising ways to finance services. Theory-based research is needed to examine adolescents' drug use trajectories in relation to their history of received services, including early psychiatric interventions, and drug abuse prevention, treatment, and aftercare services. A full understanding of how individual, social, and treatment factors interact to extend or curtail these drug use trajectories is important for developing and delivering optimally effective systems of intervention for adolescents at different developmental stages in their own maturation and in their drug use and treatment careers. Treatment needs of drug involved adolescents. Recent research on the topic of adolescent drug abuse treatment has spawned a wealth of empirical information that is being used to develop and deliver effective treatment. For years, most adolescent drug abusers were treated in programs designed for adults (White, 1998). The results were disappointing, and researchers soon determined that a firm understanding of the developmental issues of adolescence is critical for designing effective treatments for youth (Dennis, 2002). This led to a new focus on the ways in which adolescent drug users differ from their adult counterparts, and the implications these differences may have for treatment (Winters, Stinchfield, Opland, Weller, & Latimer, 2000). The importance of continued attention to the unique needs of adolescent drug abusers is further emphasized both by studies showing that treatments tailored for adolescents have been successful in reducing drug and alcohol abuse (Hser, et al., 2001), and by studies suggesting that at least one standard adult drug treatment modality—group treatment may have iatrogenic effects for some adolescents (Poulin, Dishion, & Burraston, 2001). In addition to differing from adults who use drugs, adolescents also differ from one another in potentially important ways, for instance in their gender and in their racial, ethnic, and cultural backgrounds. As more girls and more adolescents of diverse racial and ethnic backgrounds are identified to be in need of drug abuse treatment services, questions arise about the degree to which treatments need to be tailored for specific genders, or ethnic or cultural groups. Limited research has examined the effectiveness of culturally congruent assessment and treatment services on engagement, and for only a few cultural groups. Comparatively little research attention is given to gender, cultural, ethnic, and linguistic sensitivity and specificity in treatment and other health services. The extant research that does address these issues suggests that there are gender differences (Dakof, 2000) and cultural differences (Robbins, et al., 2002) in the patterns of comorbidity observed among drug abusing adolescents and in their treatment service needs. The understanding that adolescents who abuse drugs have problems and treatment needs unique from those of other populations raises the question of just who the providers delivering those treatment services should be. Given the critical nature of the therapeutic alliance in efficacious drug abuse treatment, knowledge about adolescent development and skill in relating to and counseling adolescents is of paramount importance. Moreover, given the many different systems that influence the lives of drug abusing youth (e.g., family, education, mental health, medical, welfare, criminal justice), treatment practitioners need both knowledge of these systems and skill in navigating them. Few studies have examined the adolescent treatment workforce (Pond, Aguirre-Molina, & Orleans, 2002), but there is evidence of a growing disparity between the demographic profiles of treatment providers and the adolescents they treat (Northwest Frontier Addiction Technology Transfer Center, 2000). No state in the U.S. currently offers provider certification specific to adolescents, and only five states stipulate that knowledge specific to the treatment of adolescents and youth is required for licensure (Pollio, 2002). These findings raise questions about the extent to which the cadre of practitioners currently treating adolescent drug abusers is sufficiently prepared to do so. Behavioral treatment. Advances made in behavioral treatment research for adolescent substance abuse provide a solid foundation for additional research needed to maximize treatment effects. Clinical researchers have developed individual, family, and group treatment approaches with demonstrated success in reducing drug use and improving school and social functioning. The family approaches have the most evidence of efficacy, with researchers such as Szapozcnik, Liddle, and Henggeler having designed and tested effective ways of engaging adolescents and their families in treatment, intervening with schools and juvenile justice systems, and producing robust reductions in substance use and other problematic behaviors. Individual and group approaches, while in earlier stages of development, have also shown promising results. Preliminary studies suggest that treatments based on cognitive- behavioral, 12-step, or contingency-management principles, may be effective treatments for adolescent drug abusers (Azrin, Donohue, et al., 2001; Kaminer, 2000; Winters, et al., 2000). Despite these exciting successes, rates of engagement, retention, and long- term positive outcomes are far from perfect, suggesting that more work is needed to produce maximally effective treatments. This work includes all stages of behavioral treatment development (i.e., developing and testing new treatments, adapting existing treatments, examining moderators and mediators of treatment efficacy, and testing strategies for training and supervising community providers in efficacious treatments). New treatments may take advantage of basic cognitive or developmental theory, provide clinicians with more treatment options, address the needs of special populations, etc. Adapting existing treatments for adolescents, or special populations of adolescents, may be an efficient application of potentially relevant previous work, may increase the feasibility of a treatment, and more. Identifying mediators and moderators of treatment outcomes provides crucial insight into the process of therapy development and testing. Designing clinical training and clinical supervision methods prepares an efficacious treatment for dissemination to community practice, the setting in which most adolescent treatment is delivered. This RFA addresses all stages of therapy development and places special emphasis on research investigating the degree to which treatments need to be tailored for adolescents, or for special populations of adolescents. Differences in age and developmental stage between adolescents and adults suggest that treatments developed for adult substance abusers may require significant adaptations in order to be effective with adolescents, perhaps by changing the content, scope, schedule, modality, personnel, or treatment setting. Treatments may also need to be tailored to address drugs of abuse more commonly observed among adolescents than adults, such as marijuana, ecstasy and other club drugs, and inhalants. Adolescents also differ from adults in the comorbidities observed with substance abuse; for example, both Conduct Disorder and Attention Deficit Hyperactivity Disorder are frequently observed adolescent comorbidities typically not found among adult substance abusers (Riggs & Whitmore, 1999). Special populations of adolescents, based on gender, ethnicity, or other cultural factors, may also require targeted treatments. More research is needed to determine whether targeted treatments are indicated for these and other special populations of adolescent drug abusers. Access to services. Only a fraction of adolescents who need drug abuse treatment services receive them. This fact raises questions about access and the factors, especially financing and existing pathways to treatment, that serve as facilitators and barriers to adolescents' receipt of treatment services. Over the past decade, financing for substance abuse treatment has not increased commensurately with the rise in the numbers of adolescents and their families affected by drug abuse (American Academy of Pediatrics, 2001; SAMHSA, 2001). Moreover, substantial changes in financing have included a shift in financing burden from the private to the public sector and a conversion to managed care. Financing of adolescent substance abuse treatment continues to be fragmented and inconsistent, depending largely on individuals' geographic area and type of insurance coverage. Medicaid benefits for substance abuse treatment vary widely across states (Johnson, 1999), and the emphasis continues to be on acute care services rather than on the services required for managing the chronic relapsing condition of drug abuse. New research is needed to examine the effects of private insurance, CHIPS, and Medicaid on the capacity, accessibility, breadth, integration, and effectiveness of service delivery systems for adolescent drug abusers within defined socioeconomic population sectors. Most youth who enter drug abuse treatment do so through the juvenile justice system once they have had a run-in with the law (Dennis, Dawud-Noursi, Muck, & McDermeit, 2002). Many other adolescents who use drugs are not identified until their drug behaviors escalate to abuse or dependence, or the severity of other drug-related behavioral problems catch the attention of a concerned adult with both the will and the means for responding appropriately. There are various patterns of drug use, however, among youth who need and could benefit from treatment services. New research is needed to identify and examine the range of pathways to treatment entry that will be required to provide access for adolescents at various, particularly earlier, developmental stages in their drug use careers, and to examine the factors that facilitate or impede access to treatment through these various pathways. NIDA welcomes applications to conduct health services research on improving access to treatment through innovative identification and referral systems, including, but not limited to, those supported under SAMHSA's initiative entitled, "Cooperative Agreements for Strengthening Communities in the Development of Comprehensive Drug and Alcohol Treatment Systems for Youth" (TI-03-002). By encouraging collaboration between NIDA and SAMHSA grantees, this RFA seeks to strengthen ongoing efforts to expand the range of pathways to treatment entry for adolescents. Breadth, integration, and targeting of services. Program comprehensiveness is predictive of better outcome in adolescents (Friedman & Glickman, 1986), as it is in adults (McLellan, Alterman, et al., 1994). However, the number of services provided to adolescents in treatment declined from the early 1980s to the early 1990s, and a greater proportion of adolescents in treatment perceived that their needs were not being met through the treatment services provided (Etheridge, Smith, Rounds-Bryant, & Hubbard, 2001). This decline in services has come during a time when the requirements for a broad array of services to effectively treat this population have been increasingly well-documented. Effective treatment of adolescent drug abusers often requires the collective contributions of psychological, family, educational, vocational, employment, legal, recreational, and financial services in addition to drug abuse treatment (Williams & Chang, 2000). High rates of comorbid mental health, social, and medical problems among drug abusing adolescent populations (Greenbaum, Foster-Johnson, & Petrila, 1996) are critical because co-occurring disorders can interact in ways to support problem behaviors in one or more of these domains. Those adolescents with drug abuse and mental health disorders are also at risk for sexually transmitted diseases (e.g., HIV, chlamydia, hepatitis C). Delivery of effective intervention services for these clinically complicated youth is especially challenging. The extent to which various services are fragmented or integrated may affect the degree to which they are both utilized and effective. Equally important is targeting the right services to the right adolescents at the right time in their drug use and treatment careers. Continuing care and recovery management services that support adolescents who have begun the recovery process have been underutilized and understudied. NIDA welcomes applications to conduct health services research on continuing care services, including, but not limited to, those supported under SAMHSA's initiative entitled, "Grants to Improve the Quality and Availability of Residential Treatment and its Continuing Care Component for Adolescents" (TI- 02-007). Collaboration between NIDA and SAMHSA grantees can fortify ongoing efforts to improve and expand the continuum of care provided to adolescent drug abusers. Translation of clinical treatments to community settings. Despite the growing wealth of promising scientific advances in the treatment of adolescent drug abuse (McLellan, 2002), far too little science-based treatment technology makes its way into community treatment settings in a timely manner (Liddle, Rowe, et al., 2002; McLellan, 2002). The Department of Health and Human Services has launched several efforts to speed the movement of scientific advances into the field, including the Addiction Technology Transfer Centers and the Practice Improvement Collaboratives, both supported by the Center for Substance Abuse Treatment (CSAT) of SAMHSA, and the Clinical Trials Network supported by the National Institute on Drug Abuse. Further research to strengthen the efforts to assess the impact of such work can contribute substantially to the delivery of addiction treatment services. Moreover, as advances in treatment technology continue at an accelerating pace, strategies are needed to help practitioners and community service agencies keep abreast of the research and make informed selections from among the different and promising technologies available to them. NIDA welcomes applications to conduct health services research on technology transfer initiatives, including, but not limited to, those to be supported under SAMHSA's initiative entitled, "Adoption/Expansion of Effective Adolescent Treatment Practice" (GFA No. TI-03-007). Collaboration between NIDA and SAMHSA grantees can enhance new efforts to improve the timely translation of science-based treatments into practice in community treatment settings. Research Areas of Interest This RFA is designed to support research that improves behavioral health services and treatment for adolescent drug abuse. Studies are encouraged that pay particular attention to the unique developmental needs of adolescents, including but not limited to studies in the areas listed below. Additionally, given that many adolescent developmental needs are gender-based and culturally/linguistically-based, and given the growing body of research indicating gender and ethnic differences in the trajectories to drug abuse and dependence, researchers are encouraged to take gender-based and culturally-based approaches in designing their research and proposing hypotheses. Health Services Research. Studies are encouraged in all areas of health services research on adolescent drug abuse, and the following are illustrative of the types of studies that might be proposed: o Testing and determining the utility of theoretical frameworks for examining adolescents' drug use trajectories in relation to their maturation and history of received services, including drug abuse, medical, and psychiatric interventions o Effects of different financing mechanisms—including private insurance, CHIPS, and Medicaid—on the capacity, accessibility, breadth, integration, and effectiveness of service delivery systems for adolescent drug abusers within defined socioeconomic population sectors o Availability, accessibility, organization, and financing of services, particularly as they relate to short-term and long-term public health outcomes for adolescents at different stages in their own maturation and in their drug use and treatment careers o Expansion of pathways to treatment for adolescents at various—particularly earlier—developmental stages in their drug use careers, including, but not limited to, identification and referral systems supported under SAMHSA's initiative entitled, "Cooperative Agreements for Strengthening Communities in the Development of Comprehensive Drug and Alcohol Treatment Systems for Youth" (TI-03-002); factors that facilitate or impede access to treatment through various pathways o Optimal ways to combine and deliver an expanded range of linked services, including individual and group counseling, for defined adolescent populations; comparative effects of these service models on long-term trajectories of drug use o Integrated systems for managing clinical assessments, treatment delivery, and performance monitoring, including how the use of integrated systems affects the quality, outcomes, and costs of services o Optimal continuum of care for defined populations of adolescents, including juvenile justice, HIV, and residential treatment populations, for whom reintegration into a normative life course is particularly challenging; delivery and outcomes of continuing care services, including, but not limited to, continuing care services supported under SAMHSA's initiative entitled, "Grants to Improve the Quality and Availability of Residential Treatment and its Continuing Care Component for Adolescents" (TI-02-007) o Processes and outcomes of targeting treatments for defined subgroups of adolescents based on individual, social, and environmental factors, and services characteristics o Effects of linguistically/culturally congruent, gender-sensitive, and gender-specific drug abuse treatment services on treatment retention and outcomes o Staff characteristics, knowledge, experience, and training required to maximize the effective delivery of treatment services to adolescent drug abusers o Cost efficient strategies to improve the preparedness of practicing treatment providers and train new providers o Provider strategies for developing a strong therapeutic alliance with Adolescents; effects of the therapeutic alliance on treatment outcomes o Role of state licensing requirements in improving and maintaining the preparedness of the workforce treating adolescent drug abusers o Strategies for practitioners and community service agencies to keep abreast of current research and to make informed decisions about adopting and translating science-based technologies o Processes and outcomes of technology transfer efforts, including, but not limited to, technology transfer efforts to be supported under SAMHSA's initiative entitled, "Adoption/Expansion of Effective Adolescent Treatment Practice" (GFA No. TI-03-007) o Role of technology translation in the financing, organization, and delivery of treatment services for adolescents Behavioral Treatment Research. Behavioral treatment studies are encouraged in all stages of therapy development. The following examples are illustrative of the types of research that might be proposed: o Studies developing new or refining existing behavioral treatments for adolescent substance abuse, including family, individual, and group treatment modalities; approaches based on basic cognitive or developmental science, clinical science, or theory; treatments accommodating adolescent-specific comorbidities, drugs of abuse, etc.; gender- or culturally-specific treatments o Studies developing new smoking cessation interventions for adolescents o Studies developing new behavioral interventions to reduce HIV and other infectious disease risk behavior in adolescents in drug abuse treatment o Studies clarifying the mechanisms by which adolescent treatment produces outcomes o Studies identifying mediators or moderators of treatment outcomes, such as adolescent age, developmental stage, comorbidity, gender, ethnicity, culture, drugs of abuse, etc. o Studies testing the efficacy of promising behavioral treatments or HIV risk-reduction interventions for adolescents in drug abuse treatment MECHANISMS OF SUPPORT This RFA will use NIH research project grant (R01), small grant (R03), and the exploratory/developmental grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, grantees submitting applications with direct costs in each year of $250,000 or less should use the modular format. Otherwise, follow the instructions for non-modular research grant applications. FUNDS AVAILABLE NIDA intends to commit approximately $2 million in FY 2003 to fund 5 to 8 new grants in response to this RFA. Furthermore, NIDA may give funding priority within this RFA to applications to conduct health services research on activities supported under the following SAMHSA initiatives: (a) "Adoption/Expansion of Effective Adolescent Treatment Practice" (GFA No. TI- 03-007), (b) "Cooperative Agreements for Strengthening Communities in the Development of Comprehensive Drug and Alcohol Treatment Systems for Youth" (TI-03-002), and (c) "Grants to Improve the Quality and Availability of Residential Treatment and its Continuing Care Component for Adolescents" (TI- 02-007). An applicant may request for the R01 a project period of up to 5 years and a budget for direct costs of up to $400,000 per year; for the R03 a project period of up to 2 years and a budget for direct costs of up to $50,000; and for the R21 a project period of up to 3 years and a budget for direct costs of up to $100,000. See the following program announcements at http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html and http://grants.nih.gov/grants/guide/pa-files/PA-02-171.html. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA 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 meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations Foreign applicants are not eligible for the small grant award (R03). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about health services scientific/research issues to: Beverly Pringle, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4219, MSC 9565 Bethesda, Maryland 20892-9565 Telephone: (301) 451-4998 FAX: (301) 443-6815 Email: bpringle@mail.nih.gov Direct inquiries regarding behavioral treatment scientific/research issues to: Melissa Racioppo, Ph.D. Division of Treatment Research and Development National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4230, MSC 9563 Bethesda, Maryland 20892-9563 Telephone: (301) 443-2261 FAX: (301) 443-8674 mail: mracioppo@mail.nih.gov o Direct your questions about peer review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 Fax: (301) 443-0538 Email: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131 MSC 9541 Bethesda, Maryland 20892-9541 Telephone: 301-443-6710 Fax: (301) 594-6849 E-mail: gfleming@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 Fax: (301) 443-0538 Email: tlevitin@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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/DHHS 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 Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by 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 in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse REVIEW CRITERIA The goals of NIH-supported research are to advance our 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? Innovation is particularly encouraged in conducting health services research on activities supported under the following SAMHSA initiatives: (a) "Adoption/Expansion of Effective Adolescent Treatment Practice" (GFA No. TI- 03-007), (b) "Cooperative Agreements for Strengthening Communities in the Development of Comprehensive Drug and Alcohol Treatment Systems for Youth" (TI-03-002), and (c) "Grants to Improve the Quality and Availability of Residential Treatment and its Continuing Care Component for Adolescents" (TI- 02-007). (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: 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. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 14, 2003 Application Receipt Date: April 14, 2003 Peer Review Date: July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html 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 under the Funding, or may be obtained by calling (301) 443-2755. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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. REFERENCES American Academy of Pediatrics. (2001). Improving substance abuse prevention, assessment, and treatment financing for children and adolescents. Pediatrics, 108, 1025-1029. Azrin, N. H, Donohue, B., Teichner, G. A., Crum, T., Howell, J., & DeCato, L. A. (2001). A controlled evaluation and description of individual-cognitive problem solving and family-behavior therapies in dually-diagnosed conduct- disordered and substance-dependent youth. Journal of Child & Adolescent Substance Abuse, 11, 1-43. Azrin, N. H., McMahon, P. T., Donohue, B., Besalel, V., Lapinski, K. J., Kogan, E., Acierno, R., & Galloway, E. (1994). Behavioral therapy for drug abuse: A controlled treatment outcome study. Behavioral Research & Therapy, 32, 857-866. Dakof, G. A. (2000). Understanding gender differences in adolescent drug abuse: Issues of comorbidity and family functioning. Journal of Psychoactive Drugs, 32, 25-32. Dennis, M. (2002). Treatment research on adolescent drug and alcohol abuse: Despite progress, many challenges remain. Connection. Washington, DC: AcademyHealth. Dennis, M. L., Dawud-Noursi, S., Muck, R., & McDermeit, M. (2002). The need for developing and evaluating adolescent treatment models. In S .J. Stevens and A. R. Morral (Eds.), Adolescent Substance Abuse Treatment in the United States: Exemplary Models from a National Evaluation Study. Binghamton, NY: Haworth Press. Etheridge, R. M., Smith, J. C., Rounds-Bryant, J. L., & Hubbard, R. L. (2001). Drug abuse treatment and comprehensive services for adolescents. Journal of Adolescent Research, 16(6), 563-589. Friedman, A. S., & Glickman, N. W. (1986). Program characteristics for successful treatment of adolescent drug abuse. Journal of Nervous and Mental Disease, 174, 669-679. Greenbaum, P. E., Foster-Johnson, L., & Petrila, A. (1996). Co-occurring addictive and mental disorders among adolescents; Prevalence research and future directions. American Journal of Orthopsychiatry, 66, 52-60. Hser, Y., Grella, C. E., Hubbard, R. L., Hsieh, S., Fletcher, B. W., Brown, B. S., & Anglin, D. (2001). An evaluation of drug treatments for adolescents in 4 U.S. cities. Archives of General Psychiatry, 58, 689-695. Johnson, P. (1999). Substance Abuse Treatment Coverage in State Medicaid Programs. Washington, DC: National Conference State Legislatures. Kaminer, Y. (2000). Contingency management reinforcement procedures for adolescent substance abuse. Journal of the American Academy of Child & Adolescent Psychiatry, 39, 1324-1325. Liddle, H. A., Rowe, C. L., Quille, T. J., Dakof, G. A., Mills, D. S., Sakran, E., & Biaggi, H. (2002). Transporting an adolescent drug treatment into practice. Journal of Substance Abuse Treatment, 22, 231-243. McLellan, A. T. (2002). Technology transfer and the treatment of addiction: What can research offer practice? Journal of Substance Abuse Treatment, 22, 169-170. McLellan, A. T., Alterman, A. I., Metzger, D. S., Grissom, G. R., Woody, G. E., Luborsky, L., & O'Brien, C. P. (1994). Similarity of outcome predictors across opiate, cocaine, and alcohol treatment: Role of treatment services. Journal of Consulting and Clinical Psychology, 62, 1141-1158. Northwest Frontier Addiction Technology Transfer Center. (2000). Substance abuse treatment workforce survey: A regional needs assessment. Prepared by RMC Research Corporation. ix-x, 7, 11-15, 19-20, 22-24. Pollio, D. E. (2002). States need to ensure expertise of adolescent providers through training and certification. Connection. Washington, DC: AcademyHealth. Pond, A. S., Aguirre-Molina, M., & Orleans, J. (2002). The adolescent substance abuse treatment workforce: Status, challenges, and strategies to address their particular needs. Paper prepared for the Robert Wood Johnson Foundation and presented for discussion at the Center for Substance Abuse Treatment's summit on adolescent systems of care (9/26-27/02). Poulin, F., Dishion, T. J., & Burraston, B. (2001). 3-Year iatrogenic effects associated with aggregating high-risk adolescents in cognitive- behavioral preventive interventions. Applied Developmental Science, 5, 214- 224. Riggs, P. D., & Whitmore, E. A. (1999). Substance use disorders and disruptive behavior disorders. In R. L. Hendren, (Ed), Disruptive behavior disorders in children and adolescents, 18(2). Review of psychiatry series (pp. 133-173). Robbins, M. S., Kumar, S., Walker-Barnes, C., Feaster, D. J., Briones, E., Szapocznik, J. (2002). Ethnic differences in comorbidity among substance abusing adolescents referred to outpatient therapy. Journal of the American Academy of Child and Adolescent Psychiatry, 41(4), 394-401. Substance Abuse and Mental Health Services Administration. (2001). SAMHSA fact sheet: National household survey on drug abuse, 2001. Retrieved October 8, 2002 from the World Wide Web. http://www.whitehousedrugpolicy.gov/drugfact/nhsda01.html. White, W. L. (1998). Chasing the Dragon: A History of Addiction and Recovery in America. Bloomington, IL: Lighthouse Institute Publications. (www.chestnut.org/li/publications). Williams, R. J., & Chang, S. Y. (2000). A comprehensive and comparative review of adolescent substance abuse treatment outcome. Clinical Psychology: Science and Practice, 7(2), 138-166. Winters, K. C., Stinchfield, R. D., Opland, E., Weller, C., & Latimer, W. W. (2000). The effectiveness of the Minnesota Model approach in the treatment of adolescent drug abusers. Addiction, 95(4), 601-612.


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