Note: This RFA has been superceded and is maintained for archival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
National Institute on Drug
Abuse, NIH
National Institute of Mental Health, NIH
Substance Abuse and
Mental Health Services Administration
RFA: HS-98-004
PT: 34
Purpose
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.
Eligibility Requirements
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).
Funds Available
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.
Public-Private Partnerships
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.
Research Objectives
Background
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.
- Definition of children, and children with special life situations.
Children, adolescents, and youth are defined using the definition of the
American Academy of Pediatrics; that is, those individuals from birth to
roughly age 21. Children of both genders, all racial and ethnic origins, and
financial circumstances can be affected by mental health or substance abuse
problems. It is recognized that problems may be exacerbated by specific life
circumstances. Such situations include, but are not limited to: transitions
from pre- to early adolescence; school environments and transitions, including
transitions to college; pregnancy and parenting; academic problems; trouble
with the law; neighborhood environments; and other illnesses and disabilities.
- General health sector. The general health sector is defined as
health care settings other than specialty mental health and substance abuse
settings. General health sector settings include, but may not be limited to:
integrated delivery systems (i.e., managed care other than mental health
carveouts); primary care settings such as offices and clinics where
pediatricians, family practitioners, internal medicine specialists, nurses,
nurse practitioners, and physician assistants provide health services to
children, adolescents, and youth; other ambulatory and outpatient facilities;
general acute care inpatient hospitals; and general acute care hospital
emergency departments. This RFA's reference to specific practitioners does not
exclude from potential study treatments provided by teams that include
mental-health and substance-abuse specialists (e.g., social workers,
psychologists, licensed drug abuse counselors, licensed professional
counselors, psychiatrists), as long as they work in general health sector
settings and with nonspecialist providers.
- Treatments. Mental health and substance abuse treatments are those
services designed to maintain (if improvement is not possible), or improve
identified (diagnosed or subclinical) mental health and substance abuse
problems, such as those described in the American Psychiatric Association's
Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) or the American
Academy of Pediatrics' Classification of Child and Adolescent Mental Diagnoses
in Primary Care: Diagnostic and Statistical Manual for Primary Care, Child and
Adolescent Version (DSM-PC).
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.
Research Methods
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.
Special Requirements
Budget Preparation
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.
Informed Consent
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:
Charlotte Mullican
Center for Outcomes and Effectiveness
540 Gaither
Road, Suite 2000
Rockville, MD 20850
Telephone: (301) 427-1495
E-mail:
CMullica@ahrq.gov
Application Procedures
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 20892-7910, 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
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:
Charlotte Mullican
Center for Outcomes and Effectiveness
540 Gaither
Road, Suite 2000
Rockville, MD 20850
Telephone: (301) 427-1495
E-mail:
CMullica@ahrq.gov
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."
Review Considerations
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.
Award Criteria
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.
Inquiries
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:
AHCPR
Margaret Coopey
Center for Outcomes and Effectiveness
540 Gaither Road,
Suite 6000
Rockville, MD 20850
Telephone: (301) 427-1618
E-mail:
MCoopey@ahrq.gov
or
Charlotte Mullican
Center for Outcomes and Effectiveness
540 Gaither
Road, Suite 2000
Rockville, MD 20850
Telephone: (301) 427-1495
E-mail:
CMullica@ahrq.gov
NIDA
Dorynne Czechowicz, M.D.
Division of Clinical and Services
Research
National Institute on Drug Abuse, NIH
Room 10A-10
5600 Fishers
Lane
Rockville, Maryland 20857
Telephone: (301) 443-0107
Fax: (301)
443-8674
E-mail: dc97@nih.gov
NIMH
Kimberly Hoagwood, Ph.D.
Division of Epidemiology Services
Research
National Institute of Mental Health, NIH
Room 10C-06
5600
Fishers Lane
Rockville, Maryland 20857
Telephone: (301) 443-3364
Fax:
(301) 443-4045
E-mail: khoagwoo@nih.gov
SAMHSA
Diane L. Sondheimer
Division of Knowledge Development and Systems
Change
Center for Mental Health Services
Substance Abuse and Mental Health
Services Administration
Room 18-49
5600 Fishers Lane
Rockville,
Maryland 20857
Telephone: (301) 443-1333
Fax: (301) 443-3693
E-mail:
dsondhei@samhsa.gov
Direct inquiries regarding fiscal matters to:
AHCPR
Mable L. Lam
Office of Grants Management
540 Gaither Road, Suite
4000
Rockville, MD 20850
Telephone: (301) 427-1448
E-mail:
MLam@ahrq.gov
NIDA
Gary Fleming, J.D.
Grants Management Branch
National Institute on Drug
Abuse, NIH
Room 8A-54
5600 Fishers Lane
Rockville, Maryland
20857
Telephone: (301) 443-6710
Fax: (301) 594-6847
E-mail:
gf6s@nih.gov
NIMH
Diana S. Trunnell
Grants Management Branch
National Institute of Mental
Health, NIH
Room 7C-08
5600 Fishers Lane
Rockville, Maryland
20857
Telephone: (301) 443-2805
Fax: (301) 443-6885
E-mail:
dt21a@nih.gov
SAMHSA
Christine Chen
Division of Grants Management
Office of Program
Services
RKWLII/618
5600 Fishers Lane
Rockville, Maryland
20857
Telephone: (301) 443-8926
Fax: (301) 443-1358
E-mail:
cchen@samhsa.gov
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
Current as of October
1999
Send Questions and Comments to: http://www.ahrq.gov/info/customer.htm
540 Gaither Road Rockville, MD 20850