IMPLEMENTATION OF INTERVENTION STRATEGIES FOR CHILDREN WITH DISRUPTIVE BEHAVIORS Release Date: January 18, 2000 RFA: MH-00-011 National Institute of Mental Health Letter of Intent Receipt Date: May 15, 2000 Application Receipt Date: June 13, 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 examine the implementation of prevention strategies in real world settings for disruptive behavior disorders in children and adolescents. Practice settings include schools, pediatric healthcare settings, mental health clinics, foster care settings, detention facilities, to name just a few. The purpose of this initiative is to foster studies of implementation approaches, barriers to and facilitators of implementation, and cost-effectiveness of tested preventive programs or strategies, with a focus on elucidating those elements of implementation that are necessary for sustaining preventive approaches within diverse real-world settings. Disruptive behavior disorders comprise a host of syndromes, typically including ADHD, oppositional defiant disorders, and conduct disorders. Together these disorders represent costly public health problems. Children and adolescents with these disorders often have co-occurring symptoms, such as depression or anxiety, and may display severe impairments in many domains of functioning. These impairments can lead to long-term adverse consequences, such as diminished academic performance, vocational limitations, and difficulties in social and emotional development. The purpose of this RFA is to encourage research applications that extend the evidence base on preventive interventions by taking them to a new level. That is, this RFA encourages studies of (a) implementation, replication, and deployment strategies for sustaining prevention programs targeted towards reducing risks for or the onset of disruptive behavior problems, and (b) key factors associated with successful implementation of or barriers to implementation in multiple practice settings. Since approaches to intervening with children typically involve multiple gateways or points of contact (e.g., parents/caregivers, teachers, pediatricians, etc), applications are encouraged from a wide range of disciplines and efforts to involve key stakeholders in different systems are especially encouraged. While a range of efficacious strategies for ameliorating disruptive behavior problems have been developed in the past decade, no concerted attention has yet been paid to replication of these strategies in ethnically-diverse communities nor to implementation approaches to ensure sustainability of preventive services within communities. Studies addressing these issues are encouraged. 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), Implementation of Intervention Strategies for Children with Disruptive Disorders 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and the Collaborative R01s for Clinical Studies of Mental Disorders award mechanisms. 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 a 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 is September 29, 2000. For all competing 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 a 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. Applicants interested in applying for Collaborative R01 award are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain appropriate additional information concerning the program. PAR-98-017, Collaborative R01s for Clinical Studies of Mental Disorders, is available at http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html FUNDS AVAILABLE The NIMH intends to commit approximately $1,500,000 in FY 2000 to fund 4 to 6 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years. 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 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. RESEARCH OBJECTIVES Background A robust body of research emanating from psychology, the behavioral sciences, epidemiology, education, and psychiatry has yielded over the past decade an impressive literature on risk factors for the development of disruptive behavior problems in children and adolescents. This research has produced a wealth of descriptive information about the causes and consequences of disruptive behavior problems, and has identified a range of preventive strategies for ameliorating these problems. A general consensus now exists concerning the characteristics of children, their families, and environments that are associated with the development of disruptive behavior problems, the more persistent and challenging nature of those syndromes that emerge in early childhood, and the clinical and public health importance of focusing prevention efforts on this group. There is increasing awareness that many risks influence children early in life, through events such as child abuse or neglect, and that early onset of antisocial propensities may be a key variable leading to the development of later disruptive behavior problems. The risks for older children are no less potent but involve socializing influences of deviant peers, harsh or punitive parenting approaches, and the pernicious influence of negative environments. Furthermore, it is now known that many children with disruptive behavior problems experience pronounced difficulties and impairments across multiple settings (home, school, and with peers). Children with these symptoms often experience long-term adverse effects on academic performance, vocational success, and socio-emotional development. In addition, these children are at increased risk for oppositional behavior, antisocial behavior, conduct problems and/or violence, and are overly represented in the justice system. Over the past decade, prevention science has harnessed research on risk factors to develop a range of strategies for reducing risks associated with disruptive problems of youth and for offsetting these risks by promoting positive behaviors and skills. However few of these programs are in widespread use at the local level. Communities are eager to apply effective programming but recognize that there are numerous barriers to implementing research based models in local community settings. Some of the approaches that have been developed to target precursors of these problems include home-based programs, school-based intervention models, and outreach programs through, for example, cooperative extension services. For example, a range of social skills programs, coping strategies, parent training and education, mentoring, and family support programs exist that target reduction in risks associated with the development of disruptive behavior problems. However, to date, no concerted efforts have been made to take such preventive strategies, services or programs to their logical limit: to test their implementation and deployment in multiple practice settings, including pediatric health care settings, and to identify factors that are critical for the uptake, sustainability, and longevity of these programs over time. The purpose of this RFA is to study implementation practices, barriers to implementation, costs, organizational or environmental factors related to implementation, and replication of prevention programs for diverse ethnic populations. Implementation practices refer to a range of approaches for sustaining promising programs, such as dosage effects, training issues, organizational culture and climate, and fidelity of program implementation. Barriers to effective implementation include such factors as accessibility of program for its intended audience, ethnic or cultural perspectives that limit access, and organizational or structural/administrative barriers that restrict access. Because the costs of implementing preventive programs are an important aspect of its ultimate disseminability, studies of the cost effectiveness or implementation costs are needed. Factors related to community, healthcare, school, or other organizational environments that are hypothesized to be important to the successful implementation of preventive strategies need to be studied. Finally, because there are special issues related to the replication of preventive strategies, services, or programs in different ethnic groups, such replication studies are strongly encouraged under this RFA. Information on service use and patterns of care indicate that the majority of children with disruptive behavior problems who receive any services receive them in schools. Teachers use a variety of interventions in the classroom including changing seat arrangement, behavior modification, shortened assignments, peer tutoring, parent/teacher daily report cards, and frequent breaks, however, the generalizability of these interventions across school districts or counties, the factors that mediate their sustainability in different contexts, and the cost effectiveness of them have not been studied. Available research on classroom behavioral interventions are composed largely of single-subject designs with limited generalizability. In addition, other more broadly implemented school- based interventions such as social or cognitive skills training need to be systematically evaluated for their replicability across systems. Strategies and programs such as parent management and classroom-based behavioral techniques, to name a few, have been found to improve outcomes for children with disruptive behavior disorders and their families. The broader implementation and diffusion of these approaches into different community settings will require attention to implementation practices (e.g., training, dosage, fidelity), as well as barriers to implementation and the process of service access. Data on implementation of programs in pediatric health care settings is very limited. While the second most frequent setting in which children with these problems are seen is pediatricians offices, very little attention has been focused on implementing preventive strategies within health care settings. Pediatricians may be among the first to see children who are at risk for developing disruptive behavior problems. Models for the implementation and evaluation of preventive interventions in the primary care setting are needed. With this RFA, NIMH is encouraging researchers to collaborate with service providers (teachers, pediatricians, day care professionals, etc.) to study the implementation and deployment of preventive strategies for children with disruptive behaviors. It is likely that this collaboration will stem from existing relationships or the evaluation of pre-existing interventions within these diverse settings. Interdisciplinary interventions are particularly encouraged. Listed below are examples of research areas and questions that could advance scientific knowledge about implementation and deployment. The list is not exhaustive, and it is expected that additional important research topics may be identified by those who respond to the announcement. Studies in these areas can include, but are not limited to: o Studies of the structure or organization of practice environments that facilitate or impede diffusion of preventive programs within different settings o Studies of aspects of the organizational culture or climate that affect motivational, attitudinal, or skills of direct care providers and which may be associated with the uptake and sustainability of preventive strategies into different environments o Studies of the cost effectiveness of preventive strategies when implemented in different settings o Studies of models for facilitating collaboration among service professionals that lead to sustainability of preventive strategies o Replication studies of established preventive strategies within ethnically- diverse communities, with attention to the tailoring of such programs to reflect cultural differences o Research on community-level or environmental variables that impede or strengthen training programs aimed at ensuring fidelity to implementation of research-based preventive approaches 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). It is also NIH 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 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. Kimberly Hoagwood, listed under INQUIRIES, by May 15, 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 up to a maximum of $250,000) 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. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the 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-00-011. 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, Implementation of Intervention Strategies for Children with Disruptive Disorders, MH-00-011, 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: Henry Haigler, Ph.D. National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892 Applications must be received by June 13, 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. 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: May 15, 2000 Application Receipt Date: June 13, 2000 Peer Review Date: August 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 implementation, deployment, and cost-effectiveness to: Kimberly Hoagwood, Ph.D. Services Research Branch Division of Services and Intervention Research 6001 Executive Boulevard Bethesda, MD 20892 Telephone: 301-443-3364 FAX: 301-443-4045 Email: khoagwoo@nih.gov Direct inquiries regarding new intervention development to: Farris Tuma, Sc.D. Developmental Psychopathology and Prevention Research Branch 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892 Telephone: (301) 443-9232 FAX: 301-480-4415 Email: ftuma@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 The National Center for Injury Prevention and Control (NCIPC) of CDC expects to announce availability of funds in March of 2000 to support Academic Centers of Excellence in the area of Youth Violence Prevention. The intent of these Centers will be, in part, to provide infrastructure for conducting program development and intervention oriented research. Information about the request for proposals is expected to be available on the NCIPC internet site (<http://www.cdc.gov/ncipc/ncipchm.htm>) in February. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH). 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 NIH 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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