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Note: This RFA has been superceded and is maintained for archival purposes only. Select the new Program Announcement at http://grants.nih.gov/grants/guide/pa-files/PA-07-243.html for current information on children's issues.
Agency for Health Care Policy and Research
The Agency for Health Care Policy and Research (AHCPR), in cooperation with the: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH); the National Institute of Mental Health (NIMH), NIH; and the Substance Abuse and Mental Health Services Administration (SAMHSA), invites applications for research on the effectiveness and/or cost-effectiveness of child mental health and substance abuse treatment interventions and guideline-based treatment strategies for children, adolescents, and youth in the general health sector. Guideline and other evidence- based aids for clinical decisionmaking may go beyond specific treatment interventions to include possible combinations of specific treatments. Guideline and other evidence-based aids may include algorithms, practice guidelines, treatment protocols, and practice parameters.
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. Applicants are encouraged to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone: (202) 512-1800.
Applications may be submitted by domestic or foreign, public or private organizations, including universities, clinics, units of State and local governments, firms, and foundations. AHCPR, by statute, can make grants only to nonprofit organizations; however, for-profit organizations may participate as members of consortia or subcontractors. NIH can make R01 grants to for-profit organizations. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible.
Women, members of minority groups, and persons with disabilities are encouraged to apply as Principal Investigators.
Mechanism of Support
The RFA mechanism of support is the research project grant R01. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant.
AHCPR is particularly interested in research and evaluation projects that will produce results within 1 to 3 years, although longer projects will also be supported.
Project support may not exceed 5 years (awards to foreign applicants are limited to 3 years).
AHCPR expects to award up to $1.5 million in fiscal year 1998 to support the first year of approximately 3-5 projects under this RFA. The number of awards is dependent on the number of high-quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. The earliest anticipated AHCPR award date is July 1, 1998.
NIDA expects to award up to $0.5 million in fiscal year 1998,dependent on the quality of the applications relevant to drug abuse and the availability of funds. NIMH expects to award up to $1.0 million, and SAMHSA up to $0.5 million, in fiscal year 1998, dependent upon the quality of the applications and the availability of funds.
Funding beyond the initial budget period will depend upon annual progress reviews and the availability of funds.
In order to better leverage public funds, and to address important health issues that cross both the public and private spheres, creative public-private research partnerships are encouraged. Researchers have found that such partnerships help to more quickly translate the findings of their research into real world information for physicians and other health professionals. Applicants are free to seek additional funding sources or research collaborators for these projects. Where additional parties are anticipated, their proposed role should be described in both the project narrative and the financial portions of the application. In addition, private sector entities are encouraged to consider providing additional support for meritorious applications.
Substantial numbers of children and youth are estimated to need treatment for mental health and substance abuse problems. Many of the affected children go untreated, but among those who receive care, a large percentage obtain it in general health sector settings, and that proportion may be growing.
Continuing dramatic changes in the financing, organization, and delivery of health care in the United States have put increasing emphasis on the delivery of services by nonspecialists. New cost-cutting demands have also generated renewed emphasis on the need for scientific evidence on the effectiveness of health interventions. In the arena of child mental health and substance abuse, such evidence will be useful for a variety of purposes, including: the design of systems of care for children, adolescents, and youth; prospective evaluation of proposed alternative approaches to treatment; evaluation of care provided; and examination, monitoring, and improvement of the efficiency and quality of care. Additional evidence about the effectiveness of child substance abuse and mental health services will be important to inform policymakers on issues of access to these services.
To date, most effectiveness research on child mental health and substance abuse has not examined the effectiveness of specific treatments in real world clinical settings. Rather, much of the work has focused on the effects of systems aspects such as settings and comprehensiveness of services. While systems considerations are integral to designing and providing mental health and substance abuse services to children, understanding the effectiveness of the specific treatments provided within those systems of care is also critical. Once a problem is detected or diagnosed, treatment is an essential system component. Only a small percentage of mental health services research has taken place in primary care and other general health sector settings.
Objectives and Scope
Research conducted under this solicitation will be expected to help build the evidence base on the effectiveness and cost-effectiveness of mental health and substance abuse treatments for children, adolescents, and youth in general health sector settings.
Research under this solicitation can be used to test the effectiveness of specific treatments (e.g., single pharmacotherapies or psychosocial treatments) or evidence- based treatment guidelines for specific disorders or combinations of disorders. For purposes of this solicitation, the term "specific treatments" includes both psychosocial and psychopharmacological treatments. Evidence-based treatment guidelines can include comprehensive strategies that involve multiple interventions and the procedures for their integration into a single plan of treatment.
Applications should describe all treatments (including comparison treatments) in enough detail so that they would be reproducible by other practitioners or researchers in other settings. The use of generic terms that are sometimes found in the literature (e.g., "office-based brief intervention"), with no further explanation, should be avoided.
NIMH is interested in studies of the effectiveness of treatments for specific diagnosable mental disorders, such as attention-deficit hyperactivity disorder, affective disorders, anxiety disorders, obsessive-compulsive disorders, autism, and disruptive behavior disorders.
SAMHSA is particularly interested in supporting projects that examine the effectiveness of interventions targeted to children with, or at risk for, serious emotional disturbances, and their families. Children with serious emotional disturbances have a diagnosable disorder which affects the degree or level of functioning in the family, school, and/or community, with an expected duration of more than 1 year.
This solicitation does not cover the development of guidelines or protocols for treatments; thus, only treatment guidelines that have been developed by the time of the award should be used in the research.
Screening and diagnostic services are not included under this RFA.
The research conducted under this solicitation is expected to take place in real world settings such as pediatric or family practice office or clinic settings, hospital or other emergency facilities, and managed care organizations. Effectiveness is defined as the extent to which medical (including psychosocial and psychopharmacological) interventions achieve health and/or functional improvements in real world practice settings. Real world settings include university-affiliated health care settings.
This RFA strongly encourages experimental effectiveness research (i.e., randomized and controlled studies).
Health and/or functional outcomes should be used to measure the expected effects of the treatment interventions. The use of previously validated outcome measures is strongly encouraged, as is the use of measures using children's own self-reports.
Health outcomes are the end results of the structure and processes of health care on the health and well-being of patients and populations. Examples of relevant health outcomes include reduction in symptoms, improved scores on validated mental health or substance abuse assessment instruments, and reductions in mortality or morbidity associated with mental health or substance abuse problems.
Functional outcome measures incorporate a multidimensional definition of health that encompasses physical, psychological, behavioral, and social aspects, and attempt to capture the broader impact of disease and treatment from a patient's (or parent's) own perspective. For example, can children participate in normal school activities? Can they play with friends? Can they avoid juvenile justice/law enforcement involvement? Can they live a life free of painful symptoms?
Any cost-effectiveness studies should use health and/or functional outcome measures as described above, and use as a guide suggestions found in the report of the task force on cost-effectiveness in health and medicine, "Cost-Effectiveness in Health and Medicine," published in 1996.
Interdisciplinary Research Consortia and Real World Settings
In order to improve the generalizability of findings, consortia of interdisciplinary research teams and real world clinical settings are encouraged. Existing examples of real world settings in which research is conducted include, but may not be limited to, the Practice Research Networks of the American Psychiatric Association and the Pediatric Research in Office Settings of the American Academy of Pediatrics. Interdisciplinary research teams should include physician-researchers, nurse-researchers, psychologists, sociologists, economists, and other researchers, as appropriate.
The costs of clinical care provided to any research participants will not be paid out of grant funds.
Confidentiality of Data
Information obtained in the course of a study supported by AHCPR that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers will be safeguarded.
To the extent informed consent regulations will apply to the proposed research, applicants are expected to comply fully with those requirements and to outline their proposed efforts as part of their applications.
Rights in Data
AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use these products and materials for AHCPR purposes. AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers; and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publishes research findings but relies on grantee efforts to market grant-supported products. In keeping with AHCPR's legislative mandates to make both research results and data available, copies of all products and materials developed under a grant supported in whole or in part by AHCPR funds are to be made available to AHCPR promptly and without restriction, upon request by AHCPR.
The special terms of award described above are in addition to and not in lieu of otherwise applicable PHS grant policies and Federal regulations.
Inclusion of Women, Minorities, and Children in Research Study Populations Involving Human Subjects
It is the policy of AHCPR and NIH that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Because this RFA applies solely to children, the policy on women applies to female children, adolescents, and youth.
The NIH policy resulting from the NIH Revitalization Act of 1993 (section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register on March 28, 1994 (FR 59 14508-14513), and printed in the NIH Guide for Grants and Contracts on March 11, 1994, Volume 23, Number 10. AHCPR follows the revised NIH Guidelines, as applicable.
Investigators may obtain copies from those sources or from the AHCPR Publications Clearinghouse, listed under "Inquiries."
In general, AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. Clearly, this RFA focuses exclusively on children. AHCPR announced in the NIH Guide for Grants and Contracts, Volume 26, Number 15, May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This notice is also available through AHCPR InstantFAX (see instructions under "Inquiries"). NIH published a similar notice on the inclusion of children as subjects in clinical research, in the NIH Guide for Grants and Contracts, Volume 26, Number 3, January 31, 1997. Program staff may also provide information concerning these policies (see "Inquiries").
Letter of Intent
Prospective applicants are asked to submit, by November 13, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the proposed Principal Investigator and other key personnel; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent.
The letter of intent is to be addressed to:
The research grant application form PHS 398 (rev. 5/95) is to be used when applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20857-7910, telephone: (301) 435-0714 (E-mail: ASKNIH@odrockm1.od.nih.gov).
The RFA label available in the form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the original applicants. Failure to do so 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.
Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to:
Center for Scientific Review
At the time of submission, two additional copies of the application must be sent to:
Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by January 6, 1998. If an application is received after that date, it will be returned to the applicant without review.
Conference for Prospective Applicants
AHCPR, NIDA, NIMH, and SAMHSA plan to convene a special technical assistance workshop to assist potential applicants. The purpose of this conference is to give background information and respond to any questions about the preparation of an application in response to this RFA. The workshop will be held in the Rockville/Bethesda, Maryland, area approximately 3-4 months after the publication of this announcement. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. The workshop will be open to any individual or organization intending to apply. A synthesis of pertinent Questions and Answers discussed at the prospective applicants' meeting will be available from the AHCPR Publications Clearinghouse, listed under "Inquiries." For further information on the conference, contact: Margaret Coopey or Charlotte Mullican, AHCPR; Dorynne Czechowicz, M.D., NIDA; Kimberly Hoagwood, Ph.D., NIMH; or Diane L. Sondheimer, SAMHSA, also listed under "Inquiries."
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with established peer review procedures. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score.
General Review Criteria
Review criteria for grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or proposed plan to collect data required for the project; adequacy of the plan for organizing and carrying out the project and achieving outcome measures; qualifications and experience of the Principal Investigator and proposed staff; reasonableness of the proposed budget; adequacy of the facilities and resources available to the applicant; the extent to which women and minorities are adequately represented in study populations; and when applicable, the adequacy of the proposed means for protecting human subjects.
Special Review Criteria
In addition to the general criteria above, the reviewers will assess the application's responsiveness to the RFA; generalizability of results; feasibility of answering the proposed research question(s) within the project period; research design; and the validity of outcome(s) measures.
Applications will compete for available funds with all other applications under this RFA. The following will be considered in making the funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds.
Preference in funding will be accorded by AHCPR to meritorious applications which focus on issues concerning minority populations.
Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women (females), minorities, and children in study populations, to:
Dorynne Czechowicz, M.D.
Kimberly Hoagwood, Ph.D.
Diane L. Sondheimer
Direct inquiries regarding fiscal matters to:
Mable L. Lam
Gary Fleming, J.D.
Diana S. Trunnell
Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance, Numbers 93.104, 93.180, 93.226, 93.230, 93.242, and 93.279. Awards are made under authorization of: for AHCPR, Title IX of the PHS Act (42 U.S.C. 299-299c-6) and section 1142 of the Social Security Act (42 U.S.C. 1320b-12); for NIDA and NIMH, PHS Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 U.S.C. 241 and 285); and for SAMHSA, PHS Act, Title V, section 561 et seq (42 U.S.C. 290 ff et seq), and section 501(d)(5) (42 U.S.C. 290aa). Awards are administered under the PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A; 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 and contract recipients to provide a smoke-free workplace and promote the nonuse 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.
AHCPR Publication No. 97-R067
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