VALIDATION OF CHILD MENTAL HEALTH DIAGNOSTIC MEASURES Release Date: August 13, 2001 RFA: RFA-MH-02-005 National Institute of Mental Health (http://www.nimh.nih.gov/) Letter of Intent Receipt Date: November 14, 2001 Application Receipt Date: December 14, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. USE THE MODULAR BUDGET INSTRUCTIONS THAT BEGIN ON PAGE 13 IN THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. THE INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS MUST BE USED WHEN RESPONDING TO THIS RFA. PURPOSE The purpose of this Request For Applications (RFA) is to invite applications examining the psychometric characteristics of existing diagnostic instruments for assessing the mental health of children and adolescents. Valid and reliable diagnostic tools are essential in order to document the prevalence of mental disorders in child and adolescent populations and to describe the clustering and comorbidity of symptomatology in key developmental stages. A number of assessment instruments have been developed which include structured and semi-structured diagnostic interviews and dimensional measures of psychopathology. State-of-the-art validation studies of these instruments are needed to provide accurate psychometric data on their performance in clinical as well as community-based research studies. Applications for studies that examine the usefulness of mental health screening instruments and studies that expand on ongoing clinical or community-based samples are particularly encouraged. 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 RFA, Validation of Child Mental Health Diagnostic Measures, is related to one or more of the priority areas. 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 RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. 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 many not exceed five years. This RFA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 2002. Specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (Rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NIMH intends to commit approximately $1 million in FY 2002 to fund three to five new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $350,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIMH 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 meritorious applications. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background In the absence of biological markers, which could help define the exact nature of a mental disorder and disentangle issues of comorbid symptomatology, diagnostic procedures have emphasized naming symptom clusters and identifying criteria for syndromes and mental disorders. It is essential that valid and reliable assessment instruments are available to study the prevalence and clustering of these symptoms and syndromes in child and adolescent populations. These instruments should also accurately assess external criteria for disorder, such as service use or need, and impairment and deficits in functioning at home, in school, and with peers. This information is needed from early childhood through adolescence in order to more accurately define the nosology for child and adolescent disorders while taking into account key periods in child development. Over the last 20 years, the confluence of advances in the nosology of mental disorders, interview design, computer technology and survey methods led to the construction of a variety of diagnostic measures for use with children and adolescents. These include fully-structured and semi-structured instruments such as the Children’s Assessment Schedule (CAS), the Diagnostic Interview for Children and Adolescents (DICA), the Diagnostic Interview Schedule for Children (DISC), the Interview Schedule for Children (ISC), the Child and Adolescent Psychiatric Assessment (CAPA), and the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). Assessment tools, such as these, offer the promise that the research field can describe the distribution of the major mental disorders for children and adolescents and improve the accuracy of the identification of risk factors for the occurrence and maintenance of those disorders. These instruments are also used to identify children who may need specialized mental health treatment, and it is imperative that they provide an accurate measure of the child’s symptomatology. The development of these instruments encountered a variety of methodological challenges that affect reliability and validity of diagnosis. These include: (1) the child’s developmental stage and ability to understand the meaning of questions about emotions and behaviors, (2) ongoing developmental changes in the child and in the child’s diagnostic-relevant behaviors which may or may not be part of normal development, (3) discrepant reports about the child’s behavior offered by parents, teachers, and the child, (4) the lack of a diagnostic gold standard with which to make precise comparisons of instruments, and (5) changes in the diagnostic criteria for child and adolescent disorders from editions III, IIIR, to IV of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM). Diagnostic validity of mental disorders is difficult to assess. Applicants may wish to address the different types of validity in their proposals: content validity, predictive validity, construct validity, and discriminant validity. Of particular interest are proposals which provide innovative and creative methods to move the research field forward in ascertaining validity of diagnosis, diagnostic criteria and dimensional measures of child and adolescent psychopathology. In order to distinguish between the validity of a disorder and the criteria that define it, applicants may wish to propose the identification of independent measures for disorders, which are distinct from phenomenological criteria. Research Themes and Questions Listed below are examples of research topic areas that focus on the documentation of the psychometric properties of diagnostic instruments for assessing the mental health of children and adolescents. The list of examples is illustrative, not exhaustive, it is expected that additional topics will be identified by researchers who respond to this RFA. o Predictive validity of diagnoses and dimensional measures of behavior with measures of clinical status, service use or need, functioning and impairment (at home, school, and with peers), and with severity/chronicity of mental disorder o Studies of the content, predictive, and construct validation of diagnostic instruments in understudied populations including young children, children or adolescents from diverse socioeconomic, racial/ethnic backgrounds, or geographical settings (i.e., rural/urban) o Assessments of the content, predictive, and construct validation of mental health screening instruments in relation to full instrument/assessment batteries which have adequate psychometric data o Studies that expand on existing clinical or community-based research to examine the validity of child and adolescent mental health instruments and diagnostic status over time taking into account treatment status and treatment effects o Studies that examine the construct validity of instruments that include assessing competencies and impairments associated with mental disorders and syndromes o Examination of the congruence and divergence between and among structured and semi-structured mental health diagnostic interviews, dimensional measures, check-lists, and rating-scales across child developmental periods, and for children from diverse backgrounds and ethnic groups o Develop optimum methods for determining diagnosis or clinical status as a function of different informants (e.g., parent, child, teacher, social worker, clinician) or modalities (e.g., interview, paper-pencil, computer, behavioral observation o Studies that examine factors that can affect interpretation of diagnostic classifications such as developmental mental status, measures of age-related competencies, temperament, adaptive health, and personality. o Comparing and validating alternative rules, criteria sets and diagnostic algorithms for combining and scoring information to establish diagnoses, level of functioning, severity and clinical significance SPECIAL REQUIREMENTS It is anticipated that investigators receiving these awards will attend a two-day annual meeting in Bethesda, Maryland, to discuss project progress and results. Proposed budgets should reflect these costs for the principal investigator. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 NIMH staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Karen H. Bourdon, MA, at the address shown under INQUIRIES, by the letter of intent receipt date listed. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions beginning on page 13 of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Applications must be received by the application receipt date listed in the heading of this RFA. 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 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 the NIMH in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Mental Health 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 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? 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. o The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: November 14, 2001 Application Receipt Date: December 14, 2001 Peer Review Date: March 2002 Council Review: May, 2002 Earliest Anticipated Start Date: July, 2002 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 answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Karen H. Bourdon, MA Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6198, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-5944 FAX: (301) 480-4415 Email: kbourdon@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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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