RESEARCH ON DEPRESSION COMORBID WITH EXTERNALIZING PROBLEMS IN CHILDREN Release Date: May 24, 2000 RFA: MH-01-002 National Institute of Mental Health National Institute on Drug Abuse Letter of Intent Receipt Date: August 18, 2000 Application Receipt Date: September 18, 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 This Request for Applications (RFA) solicits Research Grant Award applications from qualified applicants for research on early identification of depression (Dysthymic Disorder and/or Major Depressive Disorder) comorbid with disruptive behavior problems or disorders (persistent antisocial behavior, attention deficit hyperactivity disorder, oppositional-defiant disorder, and conduct disorder) in children under 12 years of age in pre-school, school, pediatric care, and other settings and for intervention research designed to treat or prevent these comorbid conditions. Encouraged is research using dimensional (in addition to categorical) approaches to identify risk for the development of comorbid depressive and disruptive disorders, protective factors, and opportunities for intervention. Also of interest are applications relating comorbid depressive and disruptive disorders to risk for later substance abuse outcomes. 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 Request for Applications (RFA), Research on Depression Comorbid with Externalizing Disorders in Children, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for projects to be funded for this program. 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) Small Grant (R03), Exploratory/Development Grant for MH Intervention Research (R21), or Research Project Grant (R01) award mechanism. The total project period for an application submitted in response to this RFA may not exceed two years for the R03 application (funding limited to $50,000 in direct costs per year), three years for the R21 application (funding up to $125,000 per year) and five years for the R01 application (funding limited to $350,000 per year). 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 earliest award date is March 1, 2001. For all competing R03, R21, and R01 applications, 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: Special requirements and instructions for R03 applications may be found at Special requirements and instructions for R21 applications may be found at: FUNDS AVAILABLE The NIMH intends to commit approximately $2,000,000 in FY 2001 to fund approximately six new and/or competitive continuation grants in response to this RFA. NIDA will also commit $200,000 in FY 2001 to support and co-fund grants that address substance use/abuse as well as mental health questions. An applicant may request a project period of up to two years and a budget up to $50,000 in direct costs per year for an R03, up to three years and a budget of up to $125,000 in direct costs per year for an R21, and up to five years and a budget up to $350,000 in direct costs per year for an R01. 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 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 In child psychopathology, comorbidity of disorders seems to be the rule rather than the exception, and depressive disorders tend to predominate in comorbidity profiles. Depressive disorders co-occur not only at high rates with other affective disorders (i.e., anxiety disorders), but also at high rates with disruptive disorders, such as Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), and Conduct Disorder (CD). There is evidence that childhood-onset depression conveys significant risk for continuing major depression and depression-related impairment, as well as for other clinical disorders. However, the relative clinical significance of comorbid depressive disorders and particularly those comorbid with disruptive disorders for course and outcome is unclear. Studies have found that individuals with comorbid affective and externalizing disorders face significantly elevated risk for substance use disorder outcomes. Outstanding questions include the following: whether comorbid depressive conditions are etiologically distinct from non-comorbid depressive conditions, whether different patterns of comorbidity represent different subtypes, and whether variation in developmental paths depends on age at onset of the comorbid disorders (is the onset of ADHD or ODD likely to precede or to co-occur with the onset of depression and onset of CD more likely to follow the onset of depression). Also outstanding are the following questions related to substance use outcomes: which children with comorbid conditions are at risk, what is the mechanism of risk, and what is the developmental course for those children with comorbid conditions who go on to develop problems with substance use. Evaluation of these comorbid conditions and their impact on course and outcome clearly presents a major challenge. Distinction between symptoms of disorders that portend long-term difficulties, for peer relationships and success in school, and substance use, abuse, and dependence, from those indicative of serious, but transient problems would be particularly useful. Similarly, comorbidity of depressive and disruptive disorders poses a challenge for treatment and preventive interventions. Issues include questions of which psychosocial and/or psychopharmacological treatments, alone or in combination, or which services targeting depression and/or disruptive behavior are most effective for patients with these comorbid conditions, and for the prevention of later sequelae, including substance abuse. Research Goals and Topics Studies responsive to this RFA should focus on depression comorbid with disruptive disorders in children under 12 years of age, e.g., on sequential comorbidity or concurrent comorbidity, including etiology, functional impairment, course, treatment, and outcome. Of particular interest is the clinical course of psychopathology, i.e. the significance of elevated symptom levels over time, as well as the way that depressive symptoms may precede or follow disruptive behavior problems and/or disorders as a cause, consequence or concomitant of disruptive behavior problems and/or disorders. Approaches that examine basic processes on cognition, emotions, attention, and motivation and their role in risk taking, aggressive and disruptive behavior, suicidality, and later substance use are encouraged. Also of interest are the early identification of risk and protective factors (e.g., mediating and moderating influences of life events and social contexts, such as family, school peer group) and development of strategies for intervention and prevention, including the prevention of recurrence. The following illustrate suitable approaches: o Short-term longitudinal assessment of the course of depressive disorders in children who have significant disruptive behavior problems or of course of disruptive disorders in children who have significant symptoms of depression o Secondary analysis of longitudinal data sets from studies of childhood psychopathology that contain information on comorbidity of depressive and disruptive symptoms and/or disorders and adverse outcomes, including substance use disorders o Identification and examination of risk factors and sequencing of risk factors for comorbid internalizing and externalizing behavior problems and/or disorders o Expansion of ongoing large-scale longitudinal studies on disruptive behavior or depressive disorders to include assessments that will allow examination of comorbid depressive and disruptive disorders o Development and evaluation of early recognition and intervention programs in preschool and pediatric primary care settings (e.g., social problem solving skills training) o Clinical trials testing the effects of treatment interventions for children suffering from comorbid depressive and disruptive behavior psychopathology o Studies testing the impact of mental health services for children suffering from comorbid depressive and disruptive behavior psychopathology on current functioning and later adverse outcomes, including substance use 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: 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: 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. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 the program staff listed under INQUIRIES by August 18, 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: The application is also available at 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 $350,000 per year. 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 $350,000) 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 (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 and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (see 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 role 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 arrangement 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. 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: - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, in 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-01-002. A sample modified mailing label is available at: 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, RESEARCH ON DEPRESSION COMORBID WITH EXTERNALIZING PROBLEMS IN CHILDEREN, MH-01-002, 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 J. Haigler, Jr., Ph.D. Division of Extramural Activities National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 6154, MSC 9607 Bethesda, MD 20892-9607 Bethesda, MD 20852 (for express/courier service) Applications must be received by September 18, 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 all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of depression comorbid with externalizing behavior problems in children. 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, 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? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Schedule Letter of Intent Receipt Date: August 18, 2000 Application Receipt Date: September 18, 2000 Peer Review Date: October/November 2000 Council Review: May 2001 Earliest Anticipated Start Date: July 2001 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 other than application/testing of existing interventions to: Editha D. Nottelmann, Ph.D. Division of Mental Disorders, Behavioral Research & AIDS National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9617 (or Rockville, MD 20852 for express/courier) Telephone: (301) 443-9734 FAX: (301) 480-4415 Email: Direct inquiries regarding programmatic issues of application/testing of existing interventions to: Benedetto Vitiello, M.D. Division of Services and Intervention Research National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 7149, MSC 9633 Bethesda, MD 20892-9633 (or Rockville, MD 20852 for express/courier) Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: Direct inquiries regarding programmatic issues related to drug abuse outcomes to: Naimah Weinberg, M.D. Division of Epidemiology, Services & Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 (or Rockville, MD 20852 for express/courier) Telephone: (301) 402-1908 FAX: (301) 443-2636 Email: Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 (or Rockville, MD 20852 for express/courier) Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 (or Rockville, MD 20852 for express/courier) Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) or 93.279 (NIDA). 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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