RFA-MH-00-005: DEVELOPING, TESTING AND IMPLEMENTING INNOVATIVE INTERVENTIONS FOR ADHD

Department of Health
and Human Services (HHS)

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DEVELOPING, TESTING AND IMPLEMENTING INNOVATIVE INTERVENTIONS FOR ADHD Release Date: January 21, 2000 RFA: MH-00-005 National Institute of Mental Health Letter of Intent Receipt Date: March 13, 2000 Application Receipt Date: April 27, 2000 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Mental Health (NIMH) invites research grant applications to study the development, refinement, or implementation of preventive, behavioral or other innovative interventions for children at risk for or diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD) and co- occurring disruptive behavior problems. Participants of the 1998 NIH Consensus Development Conference on the Diagnosis and Treatment of ADHD specifically recommended scientific research on behavioral interventions and their application to diverse service settings. In response to this recommendation, this RFA encourages highly focused research applications that build on emerging findings from treatment studies of ADHD, revealing how children with different symptom profiles and needs respond to different types of interventions. This RFA is meant to particularly encourage two new areas of research: (1) the development, testing and refinement of new intervention approaches, including preventive interventions, applicable to a range of settings, or (2) the study of the implementation or dissemination of already-tested and effective treatment or service interventions into diverse settings, with an emphasis on those factors that sustain those interventions over time. Given the degree of impairment noted in ADHD children additional to core symptoms, it is an NIMH priority to understand the impact of interventions on a range of outcomes, including functional improvements, such as academic achievement, learning, and attendance. Intervention development includes the conceptualization, development, standardization, and/or testing (pilot testing, field studies, or small scale experiments) of a theory-driven, empirically based intervention approach. Intervention implementation and dissemination refers to the study of the transportability of service or treatment interventions that have been shown to be effective under controlled conditions, and to those factors that impede or facilitate the widespread adoption of interventions into service systems. NIMH remains committed to supporting a broad program of research concerned with the etiology, diagnosis, assessment and treatment of ADHD that will be emphasized in subsequent research announcements. Collaboration between basic scientists and clinical researchers in response to this RFA, especially in the development of new interventions, are strongly encouraged. Furthermore, because approaches to identifying and intervening with children diagnosed with ADHD typically involve multiple points of contact (parents, educators, physicians, etc.) applications are encouraged from a wide range of disciplines and efforts to involve key stakeholders in different systems are especially encouraged. Because individual child variables (e.g., comorbid symptoms such as aggressive behavior, hyperactive and inattentive ADHD diagnostic subtypes, and age) are likely to affect the impact, implementation and sequencing of intervention strategies, the NIMH also strongly encourages applications to address these co-occurring problems in the development of new interventions or the implementation of established interventions, and to investigate the impact of such factors on treatment outcomes. 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 Request for Applications (RFA), Developing and Testing Innovative Interventions for ADHD, is related to the priority area of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for R03 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the following research grant mechanisms: Research Project Grants (RO1), Small Grants (R03), Exploratory/Developmental Grants for Mental Health Intervention Research (R21), and the Collaborative R01s for Clinical Studies of Mental Disorders award mechanisms. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. The Exploratory/Developmental Grant (R21) provides three years of funding with an average of $125,000 direct costs for each year, it is intended for pilot testing of interventions and other aspects of intervention development. The research Project Grant R01) provides up to five years of funding that is commensurate with the science proposed. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date for this RFA is September 29, 2000. For all competing R03, R21, and R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST IN TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Because the small grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. This is found at: http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html Special requirements and instructions for COLLABORATIVE R01s FOR CLINICAL STUDIES OF MENTAL DISORDERS may be found at http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html Special requirements and instructions for EXPLORATORY/DEVELOPMENT GRANTS FOR MENTAL HEALTH INTERVENTION RESEARCH may be found at http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html FUNDS AVAILABLE The NIMH intends to commit approximately $2,000,000 in FY 2000 to fund approximately 10 new and/or competitive continuation grants in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is expected that the direct costs for all R03s and R21s, as well as the R01 applications requesting up to $250,000 will be awarded in modules of $25,000, however, program and grants management adjustments may be necessary prior to award. Although the financial plans of the Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. R03s and R21s are not renewable. RESEARCH OBJECTIVES Background ADHD is a commonly diagnosed behavioral disorder of childhood that represents a costly major public health problem. There is an increasing awareness that some children diagnosed with ADHD also experience pronounced difficulties and impairment resulting from the disorder across multiple settings (home, school, and with peers). Children with ADHD often experience long-term adverse effects on academic performance, vocational success, and socio-emotional development. In addition, some of these children are at increased risk for oppositional behavior, antisocial behavior, conduct problems and/or violence, and are overly represented in the justice system. Consequently, it is critical that educators, parents, and service providers be equipped with the appropriate tools to help children with ADHD realize their learning potential and prevent a range of problem behaviors and later impairment in adolescence and adulthood. Core symptoms of ADHD include developmentally inappropriate levels of attention, concentration, activity, distractibility, and impulsivity. The fourth edition of the Diagnostic and Statistical Manual (DSM-IV) describes three different subtypes of ADHD: primarily hyperactive/impulsive, primarily inattentive, and a combined subtype. The majority of research on ADHD children has focused on the combined subtype of ADHD. Consequently, less is known about the course, diverse needs, and appropriate interventions for children diagnosed with the hyperactive/impulsive and inattentive subtypes. In addition, ADHD rarely presents itself in isolation. It is estimated that 40-90 percent of children with ADHD present with comorbid aggression or conduct problems, 25 percent with comorbid anxiety disorders, and 15-20 percent with comorbid mood disorders. Given the heterogeneous nature of ADHD, the presentation of ADHD symptoms and comorbid conditions vary widely across gender, ethnicity, and age. Consequently, effective diagnosis and intervention strategies will likely take symptom presentation, comorbidity, and demographic features into consideration. Effective treatments for ADHD have been evaluated 14-months post-intervention, however, the majority of studies examine treatment effects only for short term (approximately 3 months). Treatment outcome studies have included randomized clinical trials that have established the efficacy of stimulants for alleviating the core symptoms of ADHD, associated aggressiveness, and oppositional conduct problems, medication appears to have mixed effects on academic achievement. Initial findings of the NIMH sponsored multi-site treatment study of children diagnosed with ADHD (MTA) suggests that the combination of medication management and behavioral intervention may have a slightly greater impact on positive functioning outcomes (e.g., reading achievement, parent/child relations) than medication alone. Furthermore, the MTA provided evidence that ADHD children with various comorbid conditions likely respond differentially to treatment modalities. For instance, children with ADHD and comorbid anxiety may be less responsive to stimulant medications and more receptive to behavioral interventions. These findings suggest the importance of patient-tailored intervention strategies, however, there is still relatively little information on matching children and families to treatments to which they will be most responsive. Although evidence suggests that family variables (e.g., parental psychopathology, marital discord) and/or child variables (e.g., diagnostic subtype, comorbid symptoms) affect the implementation and sequencing of certain strategies, there is a need to further investigate these factors and their impact on treatment outcomes. This match between child characteristics, intervention components, and treatment needs has not been adequately studied. Little attention has been paid to development of preventive interventions for children who are at-risk for the development of attentional problems, yet these children are often seen in pediatric health clinics, in preschools, or in childcare settings, such as HeadStart programs. Attention to the development of early preventive interventions for young children with risk profiles are greatly needed. Information on service use and patterns of care indicate that the majority of children with ADHD who receive any services receive those that are school-based or medical, fewer families appear to pursue independent outpatient psychiatric or general mental health services. Survey reports indicate that teachers use a variety of interventions for children with ADHD in the classroom, including changing seat arrangement, behavior modification, shortened assignments, peer tutoring, parent/teacher daily report cards, and frequent breaks. Other school- based approaches include peer tutoring, social skills training and paraprofessional classroom aids. Research studies to expand the evidence base for the effectiveness of these interventions on academic and mental health outcomes for individual children are limited. For those interventions validated in controlled studies, there is a further need to study their generalizability across multiple school or pediatric settings as well as the factors that mediate their sustainability in these different contexts. In addition, other more broadly implemented school-based behavior modification interventions need to be further refined and systematically studied for their impact on children with ADHD. Care for children with ADHD in medical settings is presumed to be most typically medication management, with limited behavioral interventions. One quarter of pediatricians report never having referred their ADHD patients to tertiary medical centers or mental health clinics. Questions remain about the potential relationship between behavioral interventions in these settings and family or child treatment adherence and/or follow-up practices. Little is known about the types of behavioral interventions most amenable to implementation or collaboration within health care settings. Given the service use patterns of children with ADHD and their families, the development of innovative and flexible interventions with applications to school and medical settings are especially important. The NIH consensus conference found little evidence of coordination across public or private service sectors, such that care for children with ADHD and their families is often fragmented across social, educational, justice and health service systems. Furthermore, there appeared to be poor consistency in the treatment and follow-up for children with ADHD, and these factors impede the widespread adoption of treatment strategies for these children and their families. The conference also noted a lack of connection between basic science research and interventions. Models are therefore needed which facilitate the communication of medical practitioners, school personnel and families with regard to medication management and the incorporation of behavioral interventions and their follow-up. With this RFA, NIMH is encouraging researchers to collaborate with a variety of service providers and professionals (teachers, pediatricians, day care professionals, etc.) in developing, testing, refining, or implementing interventions for children with ADHD and co-occurring disruptive behaviors. Particularly with respect to intervention development, this RFA is encouraging collaboration between basic behavioral scientists and clinical researchers to facilitate the translation of basic science research on the cognitive/neurological processes related to ADHD (such as information processing, attention regulation, memory) into new, theory-driven intervention approaches. Listed below are examples of research areas and questions that could advance scientific knowledge on intervention development and implementation for children with ADHD. The list is not exhaustive, and it is expected that additional important research topics may be identified by those who respond to the announcement. Potential applicants are strongly encouraged to contact program staff listed at the end of this document for further information regarding the following research areas. Studies in these areas can include, but are not limited to: o Studies that pursue the development and testing of new interventions for ADHD children grounded in principles drawn from research in the basic sciences. Research questions might include: Given our understanding of basic attention regulation, general executive functioning, or long and short-term memory, how might a classroom environment or teaching strategies be structured to facilitate learning or social development for a child with ADHD? What tools or performance tasks appropriately measure outcomes in this context? How would intervention strategies differ for the different diagnostic subtypes of ADHD and comorbidity clusters? o Studies on the development of indicated prevention interventions for children at risk for developing ADHD (e.g., preschool children demonstrating early-onset ADHD symptoms). Such work may draw upon findings from the basic sciences on early attentional regulation or upon epidemiological studies of at-risk populations that identify malleable risk factors for the development of ADHD and co-occurring disruptive behavior problems. Research questions may include: What risk factors can be targeted for early prevention efforts? What kinds of preventive programs can be tested to develop new parenting strategies that pre- empt the development of problems? What strategies in home or school environments strengthen the opportunities for positive behavior change? o Studies which pursue the development and testing of novel behavioral interventions designed for pre-school, school, home, or medical settings with clinically complex and diverse children. Potential research questions might include: What are the short term effects of these interventions on child symptoms as well as functional outcomes, particularly academic achievement, family relationships, and peer group status? What new intervention strategies are needed for the different diagnostic subtypes of ADHD and comorbidity clusters? o The development and testing of new or refined school-wide, classroom, individual, or some combination of school interventions designed to increase academic achievement, appropriate social development and decrease conduct problems among ADHD children. Research projects might examine the effects of novel classroom strategies on a range of functional, symptom, and service outcomes. Research questions might include: What are the effects of these new interventions on functional improvement, subtype-specific ADHD symptoms, and comorbid symptoms? What are the effects on individual children, in particular on symptom reduction for children with ADHD and associated conduct problems? What are the effects on child-related symptom or functional improvement of new interventions designed to target school or classroom context? o Studies of the implementation process for efficacious interventions with attention to the effects of the sequencing of intervention components on outcomes. For example, if an intervention that has been demonstrated to be effective under controlled conditions is implemented in an applied setting, what effect does the implementation have upon current practice parameters in that setting? Does the implementation of a tested behavioral intervention influence follow-up procedures or patient medication adherence? o Studies of the implementation or dissemination process whereby interdisciplinary interventions or established treatments, such as medication monitoring procedures, are used to facilitate collaboration among physicians, school professionals, and families of children with ADHD. Research questions could include: What are the effects of pediatric consultation to schools on family service utilization, medication management strategies, physician practices, school referrals for ADHD evaluation, teacher practices, and child symptom and functional outcomes? What types of short-form symptom assessment tools are particularly useful and valid in medication management across school, home, and physician settings? What frequency and type of school/physician contact is necessary to adequately monitor child response to medication? 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Heather Ringeisen at the address listed under INQUIRIES by March 13, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398 (rev 4/98). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form. It is not required nor will it be accepted at the time of application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and must display the RFA number MH-00-005. A sample modified mailing label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. 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, Developing and Testing Innovative Interventions for ADHD MH-00-005, must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Heather Ringeisen, Ph.D. National Institute of Mental Health Division of Mental Disorders, Behavioral Research and AIDS Developmental Psychopathology and Prevention Research Branch 6001 Executive Boulevard, Room 6200 MSC 9617 Bethesda, MD 20892-9617 Applications must be received by April 27, 2000. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH staff. 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 NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council or Board. 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator 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 this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. Schedule Letter of Intent Receipt Date: March 13, 2000 Application Receipt Date: April 27, 2000 Peer Review Date: June/July 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: For questions regarding the development, testing, or refinement of preventive and/or treatment interventions, contact: Heather Ringeisen, Ph.D. National Institute of Mental Health Division of Mental Disorders, Behavioral Research and AIDS Developmental Psychopathology and Prevention Research Branch 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-9263 FAX: (301) 480-4415 Email: hringeis@mail.nih.gov For questions regarding the implementation or dissemination of efficacious interventions contact: Kimberly Hoagwood, Ph.D. Associate Director of Child and Adolescent Research National Institute of Mental Health 6001 Executive Boulevard, Room 7131, MSC 9131 Bethesda, MD 20892-9131 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: khoagwoo@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service 5600 Fishers Lane Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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