RISK FACTORS FOR PSYCHOPATHOLOGY USING EXISTING DATA SETS Release Date: June 23, 1999 (see reissuance PA-03-044) PA NUMBER: PA-99-121 National Institute of Mental Health THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE Under this Program Announcement (PA), the National Institute of Mental Health (NIMH) encourages extensive and innovative use of existing data sets to study the development of psychopathology or resilience in order to guide the development of prevention and early intervention strategies. The aims of the announcement are to mine the full potential of public use and other extant data sets to increase our knowledge of risk and protective factors for the development of psychopathology or resilience in community-based and clinical populations, and to encourage applications from new investigators to examine these research areas using state-of-the-art data analytic procedures. Under this PA, NIMH encourages proposals to conduct analyses using mental health research data that is in public use format or that is privately held by a principal investigator. Applicants are encouraged to integrate the intent of the recent NIMH PA "Methodology and Measurement in the Behavioral and Social Sciences" (PA-98- 031) in their proposals. Section E "Analytic Methods," emphasizes the goal of developing new and improved analytic methods to help make estimation, hypothesis testing, and causal modeling as sound as possible. This PA may be found at http://www.nih.gov/grants/guide/pa-files/PA-98-031.html. 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 Program Announcement, Risk for Psychopathology: Analyses of Existing Data Sets, 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, although foreign institutions are not eligible for NIMH R03 awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. New investigators are also encouraged to apply. MECHANISM OF SUPPORT Applicants under this PA should use either the National Institutes of Health (NIH) Small Grant (R03) award mechanism or the Research Project Grant (R01). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://www.nih.gov/grants/funding/modular/modular.htm Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R03 application may not exceed two years and funding is limited to $50,000 in direct costs per year. The R01 should be used for proposals in which additional project time and cost are clearly justifiable. It is recommended that applicants discuss the appropriate award mechanism for their study with program staff (listed under INQUIRIES). The Small Grant (R03) application includes special eligibility requirements and review criteria. The R03 also has a special application format and the narrative portion of the application is limited to ten pages. Information about the R03 may be obtained at http://www.nih.gov/grants/guide/pa-files/PAR-99-140.html . Applicants should obtain the appropriate announcement and application forms for the grant mechanism being used and are encouraged to consult with program staff listed under INQUIRIES about any questions regarding the responsiveness of their proposed project to the goals of this PA. RESEARCH OBJECTIVES The overarching goal of this program announcement is to elucidate risk factors and processes for the development of mental health problems in order to guide the development of prevention and early intervention strategies. The immediate objective is to support focused analytical research using existing data from clinical or community-based studies. These studies may have been cross-sectional or longitudinal in scope, and may be available to researchers as public use data sets, or through negotiations with principal investigators of privately held data sets. The data sets selected should have sufficient mental health data to establish a categorical or dimensional measure of mental disorder or psychopathology for the age range being studied. Analyses of cultural and ethnic variations in developmental patterns and processes leading from risk to psychopathology or resilience are encouraged. Applications for analyses of studies conducted in foreign countries will be acceptable if there is significant relevance for the U.S. population. Proposals are particularly encouraged for analyses of longitudinal data sets which have followed a cohort prospectively over time and which would allow for the application of state-of-the-art statistical analyses to evaluate the sequencing and potency of environmental, socio-economic and psychobiological risk factors in association with the developmental course of psychopathology. Innovative case control studies based on prospectively followed cohorts would be a high priority. Applicants should carefully evaluate the sampling design and rate of attrition over time of these studies to determine the feasibility of using these data sets and the generalizability of the results of the proposed analyses. Proposals involving cross-sectional data sets should include analyses aimed at the development of hypotheses about the etiology of disorders and the roles of specific risk and protective factors and processes. Proposals are encouraged which are innovative in studying the association of psychopathology to a range of potential risk factors which may be understudied. Applicants are encouraged to arrange with Principal Investigators (PIs) of ongoing or recently completed studies to use their privately held data sets for analyses. Proposals which include analyses of risk factors and models using comparable variables and assessment measures across more than one data set are also encouraged. The NIMH will provide funding to support costs for collaboration between the applicant and the PI, including relevant statistical and database support. If the PI and the applicant are not associated with the same University, the relationship may be funded through a small subcontract or consultant fee. The PI who holds the privately held data set should provide a statement of commitment to the applicant and the research being proposed, a statement of anticipated work on the project, and a budget and budget justification. Data Analyses: The data analyses proposed should include state-of-the-art biostatistical strategies suitable for complex sampling designs. These may include, but are not limited to the following: survival, life table, and hazard rate analyses; latent class variable and growth curve analyses; logistic regression; cluster analyses; structural equation modeling; random effects modeling, and methods for handling non-response and missing data. Proposals from new investigators should include consultants in biostatistical approaches to analyses of complex data sets. Examples of research topics for analyses of existing data sets include, but are not limited to, the following: o Analyses of the developmental pathways into and out of mental disorders and psychopathological symptomatology over the life span; o Analyses of adaptive factors related to positive outcomes for high risk children; analyses of factors and processes that alter negative trajectories; o Innovative person-oriented analyses to identify different configurations of risk and alternative pathways to psychopathology or resilience; o Analyses of dimensions of behavioral expression, (i.e. impulse control, executive function, affect regulation) as they inform understanding of the development, course, or outcomes of psychopathology; o Analyses of levels and patterns of symptomatology and impairment, as these relate to the nosology of mental disorders, categorical and dimensional diagnoses of psychopathology and use of mental health services, with an emphasis on child and adolescent populations; o Modeling of risk and protective processes in mediating symptoms of psychopathology, impairment and functioning; analyses of components or mechanisms underlying mediating processes; o Identification of risk factors which interact with an existing mental disorder to predict the development of subsequent, comorbid disorders; identification of patterns of risk and symptomatology that increase the likelihood of developing multiple disorders; o Analyses of processes underlying different patterns of co-occurring mental health symptomatology, substance abuse and risk-taking behaviors, particularly in adolescents and young adults; o Analyses of attributable risk associated with the development of psychopathology; o Analyses examining the role of adolescent psychopathology (including depression and antisocial behavior) on intermittent or chronic participation in violence, high risk sexual behavior, and other problem behaviors; o Analyses examining the mechanisms underlying long-term effects of abuse, neglect or other trauma; o Secondary analyses of longitudinal research, including prevention/intervention trials, to evaluate mechanisms accounting for variation in response to intervention (including social class disparities); moderating effects of contextual factors such as neighborhood, classroom structure, family changes and level of ongoing environmental stress on psychological processes and mental health symptoms; and o Analyses across data sets of assessment measures and risk and protective factors for disorders with low base rates in community populations, such as suicidal behaviors. Existing Data Sets: Information about several public use data sets which applicants may wish to consider may be obtained on the Internet. These data sets include, but are not limited to, the following: National Health and Nutrition Examination Survey III, National Center for Health Statistics (NCHS). Mental disorders of depression and mania were assessed for ages 15-39. Web address: http://www.cdc.gov/nchswww/products/catalogs/subject/nhanes3/nhanes3.htm. The 1994-1997 National Household Survey on Drug Abuse (NHSDA), Substance Abuse and Mental Health Services Administration (SAMHSA). Mental disorders assessed for adults age 18 and over were major depressive episode, generalized anxiety disorder, panic attack, and agoraphobia. Youth ages 12-17 were assessed with the Achenbach Youth Self Report Scale from 1994-1996, but this Scale was dropped from the NHSDA for 1997. A SAMSHA report on the 1994 NHSDA is available entitled "Mental Health Estimates from the 1994 National Household Survey on Drug Abuse, Advanced Report Number 15," July 1996. For further information on this survey, contact Joan Epstein, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies, (301) 443-1038. Web address: http://lion.icpsr.umich.edu/SAMHDA/studies.html. The National Longitudinal Study of Adolescent Health (ADD Health). This was an in-home survey of 27,000 adolescents. Web address: http://www.cpc.unc.edu/projects/addhealth. The National Comorbidity Survey (NCS). This was a one-wave epidemiological study of the prevalence and correlates of DSM III-R mental disorders and service use. Web addresses: http://lion.icpsr.umich.edu/SAMHDA/ncs.html; and http://www.hcp.med.harvard.edu/ncs. The National Institute of Mental Health Epidemiologic Catchment Area Survey. This study was a two-wave, five-site community-based survey of mental disorders in a sample of 20,000 adults ages 18 and over, using DSM-III diagnostic criteria. The public use data set and documentation may be purchased from the National Technical Information Service (NTIS), telephone (703) 487-4650. The National Vietnam Veterans Readjustment Survey (NVVRS) database. This is a comprehensive source of information about Vietnam and Vietnam-era veterans carried out by the Research Triangle Institute and supported by the Department of Veterans Affairs and the NIMH. It includes modules of the NIMH Diagnostic Interview Schedule for PTSD, Anxiety, Affective Disorders, Substance Abuse and Personality Disorder. A subset of the sample was selected for a clinical study using the Structured Clinical Interview for DSM-III-R. The complete database for the survey and clinical components is available from the VA Medical Center in Perry Point, MD. The contact person is Thomas Murtaugh, Ph.D., telephone (410) 642-1100, FAX (410) 642-1101, E-mail at email@example.com The 1988 National Maternal and Infant Health Survey (NMIHS) and the 1991 Longitudinal Follow-up (LF), NCHS. Both surveys contain the CES-D for the mothers, and the LF contains a brief problem behavior index on the children. Data tapes may be purchased from NTIS. Web addresses: http://www.cdc.gov/nchswww/about/major/nmihs/abnmihs.htm http://www.cdc.gov/nchswww/products/catalogs/subject/mihs/mihs.htm http://www.cdc.gov/nchs/about/major/nmihs/abnmihs.htm. The National Collaborative Perinatal Project (NCPP) sponsored by the National Institute of Neurological Disorders and Stroke (1959-1974). Data files may be ordered from the National Archives and Records Administration Center for Electronic Records, College Park, MD, telephone (301) 713-6645. Web information may be found at: http://www.archives.gov/research_room/center_for_electronic _records/national_institutes_of_health.html and http://www.nara.gov/nara/electronic/dhh.html#nih. The National Longitudinal Survey of Youth (NLSY) Child Supplements. The sample includes children born to a national sample of women from the NLSY. The women and children have been interviewed annually between 1986 and 1994 and again in 1996. The young child's behavior, temperament, and social and motor development were assessed. Youth were assessed for substance use and other behaviors. A public use data set is available from the Center for Human Resource Research, Ohio State University, 921 Chatham Lane, Suite 200, Columbus, Ohio, 43221, telephone: (614) 442-7366 or E-mail at McClaskie.firstname.lastname@example.org. The 1997 National Health Interview Survey is expected to be available in August, 1999. This survey included modules from the CIDI for adults for major depression, panic, and generalized anxiety disorders. Mental health items were included for children. The availability of this data set will be announced on the NCHS Web site at http://www.cdc.gov/nchswww. The NCHS data request telephone line is (301) 436-8500. The Murray Research Center of Radcliffe College has established an archive of longitudinal mental health data to provide research opportunities for those interested in reanalyzing longitudinal data. Web address: http://murray.hmdc.harvard.edu/mra/index.jsp. The Inter-University Consortium for Political and Social Research (CPSR). This Consortium is located within the Institute for Social Research at the University of Michigan and provides access to a large archive of computerized social science data. Web Address: http://www.icpsr.umich.edu. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application kits 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, E-mail: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: http://www.nih.gov/grants/forms.htm. 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://www.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://www.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. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://www.nih.gov/grants/guide/notice-files/not98-030.html Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. The title and number of the program announcement 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 five 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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: 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 method? 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Karen H. Bourdon, M.A. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200 MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-5944 FAX: (301) 480-4415 Email: email@example.com 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 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. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). The PHS strongly encourages all grant and contract 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, and 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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