INTEGRATING MH SERVICES RESEARCH AND BEHAVIORAL SCIENCE Release Date: March 18, 1999 PA NUMBER: PA-99-073 P.T. National Institute of Mental Health PURPOSE The purpose of this program announcement (PA) is to solicit applications for multidisciplinary research that integrate the theory and methods of the social and behavioral sciences with the questions of mental health services research. This PA is issued in response to the growing evidence that mental health services research has reached a stage in its development where the assumptions and approaches of the last decade are not significantly improving the quality of care, knowledge assimilation, or outcomes. The goals of this PA are to encourage services researchers to collaborate with basic social and behavioral scientists and to incorporate the theory and methods of their fields of study into the fundamental questions of mental health services research. 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, Integrating Mental Health Services Research and Behavioral Science, is related to the priority areas of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html 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. Foreign institutions are not eligible for Small (R03) awards. 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) individual research project grant (R01) and small grant (R03) 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 R01 application submitted in response to this PA may not exceed five years. Small Grants are for no longer than 2 years and no more than $50,000 direct costs per year. There are additional eligibility requirements, application formats, and review criteria for R03 grants. Applicants are strongly encouraged to consult with program staff listed under INQUIRIES and to obtain the appropriate additional program announcement for the R03 grant mechanism http://grants.nih.gov/grants/guide/pa-files/PAR-97-015.html. Specific application instructions have been modified to reflect the "MODULAR GRANT APPLICATION AND AWARD" process which has been adopted by the NIH (see the NIH Guide, December 15, 1998). For this PA, funds must be requested in $25,000 direct cost modules. A feature of the modular grant is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information is required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. 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 RESEARCH OBJECTIVES Mental health services research has traditionally focused on the study of the impact of the organizational structure, financing, and management of mental health services on the quality, cost, access to, and outcomes of those services. Efforts to improve services have focused on tests of various structural, financial, and management strategies. Recently, results have become available from large-scale, randomized, controlled trials of these strategies, they show that changes in structure and financing alone fail to make significantly greater improvements in clinical outcomes for those in the experimental group than for those in the treatment-as-usual group. With this program announcement, NIMH is encouraging services researchers and social and behavioral scientists to work together to try to understand these findings and address the fundamental question underlying all of mental health services research: How can we improve the mental health care provided to those suffering from mental disorders so that their functioning and quality of life improve? All of the social and behavioral sciences -- psychology, sociology, economics, anthropology, decision and management sciences, communications, social work, history, political science -- have perspectives, assumptions, theory, and methods that can be used to address this critical question. Input from the social and behavioral sciences will make it possible to examine how characteristics of the individual, his or her family, and his or her social and cultural environment affect how, when, where, and if that individual will seek care, what types of care are chosen or provided, what happens during the delivery of care, and what outcomes result. It will be possible to address how the social, cultural, and psychological characteristics of the provider interact with those of the patient or client and to examine how the variable nature of the economic, social, political, and cultural environments in which services are delivered affect (a) the organization, financing, management, and delivery of services, (b) access to services, and (c) the process, cost, and outcomes of care. The social and behavioral sciences will provide frameworks for services researchers to ask old questions in new ways. The literatures on emotion and motivation, personality development, perception, attention, learning and memory, reasoning, judgment, and communication, social influence and social cognition, family processes and social networks, and sociocultural and environmental processes may all lead to questions that services researchers would not have considered but may provide avenues for understanding what types of care work for whom, under what circumstances, and why. Listed below are examples of questions that integrate the issues of mental health services research with those of behavioral and social science. The list of examples is illustrative, not exhaustive, it is expected that additional important research questions will be identified by investigators who respond to this announcement. Questions include: o How is intrinsic motivation associated with functioning and behavior maintenance during treatment and recovery? Does this differ across disorders or cultural groups? Can intrinsic motivation be modified? What factors (e.g., culture, friends, family, personal experiences, socio-economic status) are most critical in shaping and modifying motivation? o How does the type of motivation (intrinsic or extrinsic or even coercive) influence clinical and economic outcomes of treatment? o To what extent is motivation to participate in treatment and/or family therapy associated with the degree to which the nature of the illness and its long term course are understood, at least initially? o How do stable personality traits influence the process and outcomes of treatment and rehab? Which are most valuable? Do personality traits actually remain stable after a psychotic episode? How do the clinically perceived changes in personality affect treatment responsiveness and outcomes? o How do coping (active/assertive vs. passive) and relational (e.g., openness, capacity to interact, reciprocity, attention) styles affect ability to benefit from treatment and rehabilitation? o Is high self-esteem necessary for improvement in functioning or are the treatment technologies sufficient? Does it matter if the source of the esteem is competency at tasks or relational closeness to another person? Are there other constructs of self concept (e.g., locus of control) that better predict outcomes? o What role do deficits in cognitive (perceptual, attentional, learning) and emotional functioning have in ability to benefit (improve functioning) from what types of treatment and rehabilitation? o How do patient/client experiences or histories (positive vs. negative) in the mental health system affect behavior related to treatment and rehabilitation (e.g., interaction with clinician, continuation of treatment, approach to problems encountered? o Which cognitive and emotional deficits are subject to improvement through treatment and which ones of these are most important for increasing participation in treatment and improving functioning? o What are the dominant components of perception that influence patient satisfaction - a commonly used outcome variable? o How do decision making biases influence the diagnostic abilities and treatment decisions chosen by clinicians? Are some biases more common than others with particular populations of patients/clients and/or with particular types of physicians? o Does problem solving ability (including both affective and instrumental tasks/problems) affect willingness to participate in treatment, response to treatment, functioning/disability, and other outcomes? o How do interpersonal communication styles of clinicians (e.g., authoritarian, egalitarian) and patient preferences for particular styles interact to affect willingness to participate in treatment, response to treatment, functioning/disability, and other outcomes? Are patient preferences for clinical style consistent across mental health professionals? o How can clinicians be influenced to adopt, in their treatment of patients/clients with mental disorders, the information from efficacy trials? Does issuing official practice guidelines make it more or less likely that clinicians will use best practices? What other strategies might be used to improve practice? o What mechanisms can be used to get people to seek care for themselves or family members, when they need it, even if their social or cultural environment discourages it? o What dynamics within families, other than negative constructs like expressed emotion, are important in understanding patient/client recovery? How do those dynamics interact with personality and disorder characteristics? What mechanisms or patterns of relating within families best help patients/clients cope with stresses in the environment, such as emotional, financial, work, treatment, and legal? Are successful patterns culture- specific or person-specific? o Do psychoeducational approaches work for all types of families? For what types of families should individual family psychoeducation be used instead of group? How can psychoeducation and other family therapies be modified to address the cultural and educational diversity of various family groups? o Does acceptance or non-acceptance of the dominant culture by the patient/client and/or his/her family affect use of services, patient/client goals, response to clinical providers, degree of independence achieved, and improvement in functioning during and after treatment? o How do the perceptions of caretaker burden (psychological and economic) differ by family structure, family dynamics, and culture? o How do cultural explanations for disorder affect receptivity and response to treatment, particularly when patient/client and family explanations differ from those of the mental health clinicians? o Do culture and socioeconomic status influence the decision-making strategies used by patient/clients, their families, and clinicians? If these approaches differ, does this increase the risk of distrust, confusion, noncompliance, and/or treatment dropout? 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/0grants/guide/1994/94.03.18/notice-nih-guideline008.html NIH POLICY AND GUIDELINES ON THE 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. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted on the standard receipt dates 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. BUDGET INSTRUCTIONS 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 - Use 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. 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. 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. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. 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 current position(s) and then previous positions, - List selected peer-reviewed publications, with full citations, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. o OTHER SUPPORT - Form Page 7. This form must be completed for applications in response to this PA to allow awards to be negotiated and made on or before September 30, 1999. 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. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. 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 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 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 that are complete will be evaluated for scientific and technical merit by an appropriate peer 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, when applicable. 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. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved 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: Emeline Otey, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Blvd., Room 6180 MSC 9625 Bethesda, MD 20892-9625 Telephone: 301-443-9284 FAX: 301-443-4611 Email: eotey@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) 443-3065 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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