EXPLORATORY/DEVELOPMENT GRANTS FOR MH INTERVENTION RESEARCH Release Date: August 5, 1999 (see replacement PAR-03-078) PA NUMBER: PA-99-134 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 This Program Announcement (PA) replaces PA-93-093, which was was published in the NIH Guide, Vol. 22, No. 21, June 11, 1993. The National Institute of Mental Health (NIMH) is requesting research grant applications to (a) develop somatic, pharmacologic, psychosocial, or combination interventions for the prevention, rehabilitation, treatment and/or management of mental disorders, emotional or behavioral problems, the co- occurrence of mental, physical and substance abuse problems, and the functional consequences of these problems across the life span; and (b) perform preliminary tests of feasibility, acceptability, and efficacy/effectiveness of interventions. This program announcement is designed to support phases of intervention development that are prerequisite to (but do not include) conducting a full-scale intervention trial. This program announcement is intended to encourage intervention research applications in understudied disorders or problematic behaviors, populations, and settings, as described in two recent NIMH National Advisory Mental Health Council reports, "Priorities for Prevention Research at NIMH" and "Bridging Science and Service," both of which can be obtained at http://www.nimh.nih.gov/research/reportmenu.cfm. 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 PA, Exploratory/Development Grants for MH Intervention Research, is related to the priority area of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Exploratory/Development Grant R21 mechanism. The Exploratory/Development Grant is limited to an average of $125,000 in direct costs per year for up to 3 years. While variations from year to year are permissible, in no case may any year be more than $200,000 in direct costs, and total direct costs for the entire project period may not exceed $375,000. If less than 3 years are requested, the maximum amount of the total direct costs may not exceed $125,000 per year. Individual grants are not renewable. Annual awards will be made, subject to continued availability of funds and progress achieved. Applicants with sufficient pilot data to demonstrate feasibility of an intervention study are not eligible for this award and should pursue an alternative grant mechanism, such as the 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 RESEARCH OBJECTIVES Summary Exploratory/Development grants for Mental Health interventions research are designed to support the early phases of intervention development or adaptation, preliminary to and leading up to a full-scale (e.g., randomized controlled, interrupted time series) trial that could take place in a clinical or community setting. Intervention is broadly defined to include efforts to prevent disorder, as well as efforts to treat disorder in the acute and later phases, such as continuation, maintenance, relapse prevention and to rehabilitate by reducing residual symptoms and enhancing function. Although applicants may utilize procedures that maximize internal validity when developing new interventions, Exploratory/Development Intervention Grant applications should state their relevance to public health intervention approaches and outcomes. Intervention studies with a public health focus are designed to maximize generalizability of findings to broad populations, providers, and settings. They have broad sample inclusion and relatively few exclusion criteria. Exclusion criteria are based more on concerns for participants' safety than on achieving tight control over extraneous sources of variation that may complicate causal interpretations of intervention effects. Age, gender, and comorbidity are seen as important dimensions on which to ensure sample representativeness and generalizability, rather than as bases for participant exclusion. Potential intervention outcomes are broadly construed and evaluated, to include performance (school, work, etc.), relationship functioning (family, interpersonal, etc.), disability, quality of life, morbidity (including diagnostic status), mortality, institutionalization, and health care resource use. In developing an intervention with public health relevance its potential application to, and adaptation by an applied setting (e.g., specialty or primary care, school or work-site) should be described. Testing the effectiveness of commonly used but relatively unproven self treatments (e.g., self-help, support groups) are encouraged. Development of intervention approaches applicable to understudied high risk behaviors and events (e.g., suicide attempts, exposure to traumatic events) and understudied mental disorders and behavioral problems (e.g., obsessive-compulsive disorder, anorexia nervosa) is encouraged. Intervention development can be considered to have three stages: 1) conceptualizing an intervention approach based on theory and empirical research, 2) developing and standardizing the intervention, and 3) pilot testing. This mechanism will fund research conducted at the second and/or third stages. (Stage 1 needs to be completed prior to submission of the application). Investigators are not expected to necessarily complete all phases of intervention development during the 3-year duration of the award. They should propose feasible and systematic goals that can be accomplished within the time and funding constraints of this award while considering the final aim of completing the prerequisites for conducting a controlled study. The stage of the proposed work should be consistent with the stage of scientific research thus far accomplished with regard to the population or disorder to which it is to be applied. Intervention standardization (Stage 2) includes components such as the following: development of a treatment protocol, operationally defining intervention components for use in creating a manual (e.g., psychosocial intervention manual, initial medication dosing level), development or adaptation of relevant measures, including diagnostic, cost and outcome measurement); formulation of measures of provider competency, acceptance and adherence to the protocol, and participant behavior change, acceptance and adherence to treatment. Pilot and feasibility studies (Stage 3) may include: testing and further refining of initial intervention manual and measures developed during Stage 2; gathering data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) and performing preliminary power analyses; evaluating feasibility of procedures for implementing and evaluating the intervention in a controlled outcome study (e.g., participant and provider recruitment, sample definition, intervention assignment, and outcome measures). Sample sizes for Stage 3 should be appropriately estimated to answer the relevant questions about the adequacy of the intervention development, or to establish reliable estimates of intervention effect parameters prior to trials, as applicable. Types of Exploratory/Development Grants for Intervention Research Interventions under consideration may be delivered independently of other previously funded services, as an enhancement of these services, or as part of a package of services. Interventions may target either risk or protective factors, or both. Such factors may be either unique to a disorder, or common to a number of disorders. For preventive interventions, sample populations may be asymptomatic, symptomatic, previously symptomatic and/or diagnosed. Preventive interventions may be aimed at minimizing relapse, recurrence, side effects, or preventing comorbid symptoms or disorder. Integrated preventive, rehabilitative, and treatment strategies should consider the timing and sequencing of interventions, as well as the development of incremental outcome measures that could reflect cumulative effects of multiple interventions. Outcomes may be defined at the individual, group, system, or populations levels, or any of these in combination. The following are illustrative, but not restrictive, topics for consideration for Exploratory/Development studies: o Develop approaches to defining and standardizing a credible, active placebo, or other control treatment condition (e.g., treatment as usual), including patient preferences, in order to improve intervention designs o Develop and test experimental methods for training providers, and develop less burdensome approaches to assessing provider and participant adherence o Operationalize and manualize treatments that are often used but rarely tested for effectiveness (e.g., play therapy for children with disruptive behavior) o Develop off-label or innovative applications of established treatments o Develop novel interventions for treatment resistant patients, including those with comorbid symptoms or disorders o Adapt specific interventions already established as efficacious with adults for children and adolescents (e.g., treatments for anxiety disorders, including PTSD) o Develop approaches to transporting efficacious interventions to culturally diverse settings, including the testing of fidelity of adapted interventions o Determine the feasibility and likely effect size of multiple setting (e.g., school, family, peer, and after-school child care) interventions to prevent symptoms or disorder and promote functional competencies o Propose research to determine optimal combinations of pharmacologic and psychosocial interventions to improve functioning (e.g., psychostimulants and psychosocial treatment of ADHD with titration of stimulants) o Develop family-based education, maintenance and rehabilitative strategies that can be added and tested in conjunction with individual intervention approaches o Determine the feasibility and dosing range of new or existing interventions to prevent or minimize consequent symptoms (e.g., brief psychosocial and/or pharmacologic treatment of trauma victims seen in emergency rooms to prevent later PTSD) o Develop innovative interventions for disorders for which few efficacious interventions exist (e.g., hypochondriasis, anorexia, trichotillomania and other self-mutilating disorders, dissociative disorders, borderline personality disorder, childhood feeding disorders, autism) o Propose methods for analyzing existing intervention data from multiple studies as a step in developing more refined intervention approaches (e.g., improving fidelity, identifying predictors of response and failure, defining alternative outcome measures) o Pilot test strategies to modify the physical and social aspects (e.g., family, community support or institutional care staff skills) of patients environments to improve symptom management and individual functioning o Pilot test the feasibility of interventions in practice settings and assess the needs of stakeholders (patients, specialty providers, primary care providers, insurance payers, employers who purchase insurance, government provided insurance, etc.) o Develop and test methods for the adoption, diffusion, and long term use of administrative and/or technical innovations in treatment or service settings o Develop system level interventions to improve practitioners (e.g., day care providers, foster care cases workers, school psychologists, nurse practitioners) abilities to provide effective care and implement indicated interventions o Pilot test interventions that promote functional competence and identify and treat early signs of disorder in high-risk groups (e.g., offspring of parents with mental disorders or substance abuse, older persons being transferred from acute to long-term care settings) o Develop innovative rehabilitative strategies to address neurocognitive (memory, language, executive function), neuromotor (motor retardation, visuo- motor dysfunction, perceptual (visuo-spatial, sensory integration, body image) and homeostatic, or other regulatory deficits which contribute to functional impairment or treatment compliance o Develop innovative rehabilitative interventions to address particular strengths or plasticity For Exploratory/Development grants, the goals of the study should be clearly outlined and related to specific aims and procedures pertinent to whichever phase(s) (i.e., stages 2 or 3) of intervention development will be pursued. It is acknowledged that boundaries between the stages outlined above are non- discrete and therefore, investigators may propose ideas or methods including subsets of one or more categories. Importantly, however, the application should include a clearly operationalized description of each component step, with decision points indicating when each has been successfully completed and when to move on to subsequent components. The development of both empirically indicated and theory-driven interventions is encouraged. Adaptation of existing treatments to new populations, settings, etc. is considered innovative within a public health model. Applications will be assigned within the National Institute of Mental Health according to the following guidelines: Proposals for standardizing or manualizing new non-pharmacologic interventions, assessing safety, feasibility, and acceptability of new interventions and collecting pilot data prerequisite for a full-scale trial of a novel intervention will be assigned to the Division of Mental Disorders, Behavioral Research, and AIDS. Proposals for pilot testing existing clinical services in broader populations (e.g., additional patient groups or disorders) or new settings, pilot testing or refinement of existing treatments (e.g., shortened or extended periods of treatment), standardizing protocols for routine clinical care or services, new approaches to combining, sequencing, or timing existing interventions, and experimental approaches to training providers to deliver proven interventions with better fidelity, will be assigned to the Division of Interventions and Services Research. 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://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.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://www.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. APPLICATION PROCEDURES 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. See MECHANISM OF SUPPORT, above, for the amounts which may be requested. 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) 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. 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: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. 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. See final two paragraphs under "RESEARCH OBJECTIVES," which discuss the assignment of applications within the National Institute of Mental Health. Direct inquiries regarding programmatic issues to: Peter Muehrer, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6190, MSC 9615 Bethesda, MD 20892-9615 Telephone: (301) 443-4708 FAX: (301) 443-4611 Email: pmuehrer@nih.gov Linda L. Street, Ph.D. Division of Intervention and Services Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: Lstreet@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 inter-governmental 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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