EARLY IDENTIFICATION AND TREATMENT OF MENTAL DISORDERS IN CHILDREN AND ADOLESCENTS Release Date: May 17, 2000 PA NUMBER: PA-00-094 (This PA has been reissued as PA-06-442) 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 The National Institute of Mental Health (NIMH) invites research grant applications for research on early identification and treatment of mental disorders in children and adolescents. In particular, this announcement intends to encourage research on disorders such as schizophrenia, schizoaffective disorder, bipolar disorder, major depression, obsessive- compulsive disorder, and anorexia nervosa, alone or comorbid with other common mental or substance abuse disorders. These disorders are considered to be in special need of investigation because of their chronicity, high morbidity, and relative dearth of data in children and adolescents. Research on autism and other pervasive developmental disorders is specifically addressed by a separate program announcement ( Research in Autism and Autism Spectrum Disorders , PA-98-108), which is located at http://grants.nih.gov/grants/guide/pa-files/PA-98-108.html. Mental disorders often start early in the life course. Early detection and treatment of the disorders may result in a better prognosis and functional outcome in adult life. Little is known on how to identify promptly and accurately children and adolescents suffering from early signs of mental illness. The diagnostic interpretation of behavioral symptoms, such as extreme mood lability, social withdrawal, and disturbances in perception and cognition, is often difficult and at times controversial. In parallel, the available data on the efficacy and safety of treatment interventions for these children are very limited. This initiative calls for more research on the (1) validation of early diagnosis of mental disorders in youths, and especially in young children, (2) development of new interventions to treat mental disorders and prevent the exacerbation of, and functional impairments associated with, these disorders, (3) testing of the efficacy and safety of treatments, both new and already in use among young patients with mental illness, (4) study of access or barriers to services and effectiveness of services for these patients, (5) testing of the long-term effectiveness and safety of treatment interventions for young patients with chronic or recurrent disorders, (6) assessment of the long-term impact of early intervention, especially on disease progression and prognosis, (7) identification of early signs of anorexia nervosa that could serve as targets for interventions, and (8) identification and evaluation of predictors of treatment response for new and existing interventions for children and adolescents with mental illness. Intervention strategies to be studied can include pharmacological, psychosocial, and rehabilitative interventions, separately or in combination. 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 Program Announcement (PA), Early Identification and Treatment of Mental Disorders in Children and Adolescents , is related to the priority areas of the Mental Health and Mental Disorders Objectives. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ 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 PA will use the National Institutes of Health (NIH) R01, collaborative R01, and R21 grant 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 PA may not exceed five years (three years for the R21). For all competing R01 applications requesting up to $250,000 per year in direct costs and all R21 applications, specific applications 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. Because the R21 grants have a special application format and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Special instructions and information for the Exploratory/Development Grants for MH Intervention Research, can be found at http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html. Information on Collaborative R01 applications may be found at Collaborative R01s for Clinical Studies of Mental Disorders, PAR-98-017, which is located at http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html RESEARCH OBJECTIVES Background Mental disorders often become evident in adolescence. Some disorders, such as obsessive-compulsive disorder, bipolar disorder, and major depression, not uncommonly emerge even earlier in life. The diagnosis of schizophrenia is seldom made in prepubertal years. In part, this is due to the current uncertainty in interpreting symptoms of abnormal cognitive and behavioral functioning in childhood. A few studies on prodromal signs of psychosis in children and adolescents have been initiated. This research may shed light on the therapeutic value of very early treatment interventions. Bipolar disorder can be usually recognized during adolescence, but, in many cases, it may be difficult to formulate a definitive diagnosis in prepubertal years. Controversy exists among experts on how to interpret extreme volatility of mood, temper, and behavior in children, and especially in young children. Arriving at a valid and prompt diagnosis of mental disorder in children is essential. Early diagnosis can lead to appropriate treatment interventions and, possibly, to a better prognosis for the patient. If the disorder is not properly recognized, children may be left untreated or exposed to inappropriate treatments that may worsen the underlying disorder. On the other hand, an inaccurate diagnosis can lead to unnecessary exposure to medications, such as antipsychotics, mood stabilizers, or antidepressants, which have potential negative side effects. Thus, research aimed at increasing the ability to arrive at valid and early diagnoses of disorders such as schizophrenia, bipolar disorder, and other chronic and impairing mental disorders is urgently needed. No adequate information exists on the efficacy and safety of antipsychotic medications prescribed to youths with schizophrenia and other psychotic disorders. This dearth is particularly evident for the atypical antipsychotics. Likewise, limited data are available on the efficacy and safety of commonly used mood stabilizers for the treatment of bipolar disorder. Extrapolation of data from adult studies is in general not appropriate, especially with respect to safety data, as children may be more prone to certain medication side effects than adults. Controlled studies are needed to address these issues, with special emphasis on the long-term impact of these treatments on symptoms, disorder prognosis, cognitive functions, and development in general. In the case of obsessive-compulsive disorders, treatments exist, but for many patients their impact is limited, as reflected by an average response rate of about 60 percent. This indicates that at least one-third of patients with this chronic condition cannot be successfully treated with the current modalities. Novel and more effective interventions are needed. For anorexia nervosa, there is very little known about how to intervene on early symptoms in order to change the course of the illness. Important ethical issues emerge when considering, planning, and conducting early treatment research in the prodromal phase of mental disorders. A distinction must be clearly made between treatment of existing symptoms that are accompanied by clinical dysfunction, on one hand, and preventive interventions for subjects currently at risk but not clinically impaired, on the other. This program announcement focuses on research on clinically impairing psychopathology and not on asymptomatic subjects who are at risk for mental illness. Researchers considering studies on prevention of psychotic disorders through study of early symptomatic manifestations are referred to PA-99-090, Prevention and Early Intervention in Psychotic Disorders , which is located at http://grants.nih.gov/grants/guide/pa-files/PA-99-090.html. Some illustrative examples of research topics that may be addressed under this program announcement are: o Improving the validity of the diagnosis of mental disorders in children and adolescents. o Understanding the diagnostic predictive value of early manifestations of mood and behavioral dysfunction as presented by children and adolescents, and especially young children. o Improving the ability to differentiate among possible alternative diagnoses, especially for those clinical situations where alternative diagnoses can lead to substantially different treatment approaches (e.g., bipolar disorder vs. attention deficit hyperactivity disorder or conduct disorder). o Determining the potential impact of early treatment on the course of illness. o Testing the efficacy and safety of antipsychotic medications in youths with psychosis. o Testing the efficacy and safety of mood stabilizing medications in youths with bipolar disorder. o Testing the efficacy and safety of psychosocial treatment interventions for youths with disorders such as schizophrenia, bipolar disorder, depression, and anorexia nervosa. o Studying the long-term efficacy and safety of pharmacological and psychosocial treatments for youths with schizophrenia, bipolar disorder, depression and other mental disorders. o Studying the possible impact on child development of exposure to medications commonly used in the treatment of mental disorders, particularly when treatment is long-term and starts in early childhood. o Testing the efficacy and safety of psychosocial and pharmacological interventions for youths with mental disorders such as schizophrenia, bipolar disorder, depression, and anorexia nervosa, when these disorders are comorbid with other common psychopathology, such as attention deficit hyperactivity disorder and substance abuse. o Examining access or barriers to services or models of service delivery that optimize treatment access, adherence, or satisfaction with services. o Investigating the impact of school, health services or models of coordination of delivery systems on outcomes for youth with chronic and impairing mental disorders. o Developing and testing treatment approaches for youths with chronic and impairing psychopathology that can be adequately described and quantified, even if it does not meet full diagnostic criteria for a disorder as defined in the current nosology. o Developing new treatment approaches for youths with severe forms of obsessive-compulsive disorder that have proven unresponsive to usual treatments. o Elucidating and addressing the ethical implications of early treatment vs. non-treatment in situations of diagnostic uncertainty. o Comparing the effects of alternative, promising treatment strategies. o Determining the risk/benefit ratio of treating children and adolescents with early manifestations of psychosis, bipolar disorder, and recurrent depression and other chronic and impairing mental disorders. o Identifying and characterizing individual, family, and/or cultural factors that facilitate or impede early identification, detection, and treatment of chronic and impairing mental illness in youth. o Identifying and characterizing current practice patterns for youths with chronic and impairing mental illness, studying variables that affect quality of care, and developing and testing interventions designed to improve quality of care for youths with these psychiatric disorders. 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 have been 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 the following URL address: 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 these policies 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. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. 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, Email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: http://grants.nih.gov/grants/forms.htm. 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 ($125,000 for R21). (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 or $125,000 for R21) 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. o 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. o 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. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further 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://grants.nih.gov/grants/guide/notice-files/not98-030.html Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without 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 by NIH 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: 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? 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 assigned to the Institute. 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 about diagnosis and detection of mental disorders to: Editha D. Nottelmann, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6193, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-9734 FAX: (301) 480-4415 Email: enottelm@nih.gov Direct inquiries regarding programmatic issues about testing effects of treatment interventions to: Benedetto Vitiello, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7147, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: bvitiell@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 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 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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