Full Text HS-98-004
NIH GUIDE, Volume 26, Number 20, June 13, 1997
RFA:  HS-98-004
P.T. 34, AA

  Emotional/Mental Health 
  Drugs/Drug Abuse 
  Rehabilitation/Therapy, Emotional 
  Treatment, Medical+ 

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
Letter of Intent Receipt Date: November 13, 1997
Application Receipt Date: January 6, 1998
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.
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 non-profit 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.
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 three 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 policy makers 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.
o  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.
o  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 non- specialist providers.
o  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
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
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 one 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
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
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.
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
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
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.  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 on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which were published in the Federal
Register of March 28, 1994 (FR 59 14508-14513), and in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.
AHCPR follows the revised NIH Guidelines, as applicable.
Investigators may obtain copies from those sources or from the AHCPR
contractor, Global Exchange, Inc., 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, 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 available through AHCPR's WEB site
(http://www.ahcpr.gov) and InstantFAX (see instructions under
INQUIRIES).  NIH published a similar Notice on the inclusion of
children as subjects in clinical research, in the NIH Guide, Volume
26, Number 3, January 31, 1997.
Program staff may also provide information concerning these policies
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 Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Telephone:  (301) 594-1485, ext. 1201
FAX:  (301) 594-3211
Email:  chdmhrfa@ahcpr.gov
The research grant application form PHS 398 (rev. 5/95) is to be used
in 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 (email:
AHCPR applicants should obtain application materials from the AHCPR
contractor:  Global Exchange, Inc. (see INQUIRIES).
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 YES must be
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
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 Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Telephone:  (301) 594-1485, ext. 1201
FAX:  (301) 594-3211
Email: chdmhrfa@ahcpr.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.
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
contractor, Global Exchange, Inc., 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
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
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.
Copies of the RFA should be obtained from:
Global Exchange Inc.
7910 Woodmont Avenue, Suite 400
Bethesda, MD  20814-3015
Telephone 301/656-3100
FAX 301/652-5264
The RFA is also available on AHCPR's website, http://www.ahcpr.gov
and through AHCPR InstantFAX at 301/ 594-2800.
To use InstantFAX, you must call from a facsimile (FAX) machine with
a telephone handset.  Follow the voice prompt in order to obtain a
copy of the table of contents, which has the document order number
(not the same as the RFA number).  The RFA will be sent at the end of
the ordering process.  AHCPR InstantFAX operates 24 hours a day, 7
days a week.  For questions about this service, call AHCPR's Division
of Communications at 301/594-1364, ext. 1389.
Direct inquiries regarding programmatic issues, including information
on the policy of inclusion of women (females), minorities, and
children in study populations, to:
Margaret Coopey
Office of the Forum for Quality and Effectiveness in Health Care
Agency for Health Care Policy and Research
6000 Executive Boulevard, Suite 310
Rockville, MD  20852
Telephone:  (301) 594-4015, ext.1788
FAX:  (301) 594-4027
Email: chdmhrfa@ahcpr.gov
Charlotte Mullican
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Telephone:  (301) 594-1485, ext. 1201
FAX:  (301) 594-3211
Email: chdmhrfa@ahcpr.gov
Dorynne Czechowicz, M.D.
Division of Clinical and Services Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-10
Rockville, MD  20857
Telephone:  (301) 443-0107
FAX:  (301) 443-8674
Email:  dc97@nih.gov
Kimberly Hoagwood, Ph.D.
Division of Epidemiology Services Research
National Institute of Mental Health
5600 Fishers Lane, Room 10C-06
Rockville, MD  20857
Telephone: (301) 443-3364, ext.
FAX:  (301) 443-4045
Email:  khoagwoo@nih.gov
Diane L. Sondheimer
Center for Mental Health Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, Room 18-49
Rockville, MD  20857
Telephone:  (301) 443-1333
FAX:  (301) 443-3693
Email:  dsondhei@samhsa.gov
Direct inquiries regarding fiscal matters to:
Mable L. Lam
Office of Grants Management
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone:  (301) 594-1447, ext. 1165
FAX:  (301) 594-3210
Email:  mlam@ahcpr.gov
Gary Fleming, J.D.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  dt21a@nih.gov
Christine Chen
Division of Grants Management
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, Room 618
Rockville, MD  20857
Telephone:  (301) 443-8926
FAX:  (301) 443-1358
Email:  cchen@samhsa.gov
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)(i) (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 non-use of all tobacco
products.  In addition, Public Law 103-227, The Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

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