EXPLORATORY/DEVELOPMENT GRANTS FOR MH INTERVENTION RESEARCH

Release Date:  August 5, 1999 (see replacement PAR-03-078)

PA NUMBER:  PA-99-134

National Institute of Mental Health

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS PA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

This Program Announcement (PA) replaces PA-93-093, which was was published in
the NIH Guide, Vol. 22, No. 21, June 11, 1993.

The National Institute of Mental Health (NIMH) is requesting research grant
applications to (a) develop somatic, pharmacologic, psychosocial, or
combination interventions for the prevention, rehabilitation, treatment and/or
management of mental disorders, emotional or behavioral problems, the co-
occurrence of mental, physical and substance abuse problems, and the
functional consequences of these problems across the life span; and (b)
perform preliminary tests of feasibility, acceptability, and
efficacy/effectiveness of interventions.  This program announcement is
designed to support phases of intervention development that are prerequisite
to (but do not include) conducting a full-scale intervention trial.  This
program announcement is intended to encourage intervention research
applications in understudied disorders or problematic behaviors, populations,
and settings, as described in two recent NIMH National Advisory Mental Health
Council reports, "Priorities for Prevention Research at NIMH" and "Bridging
Science and Service," both of which can be obtained at
http://www.nimh.nih.gov/research/reportmenu.cfm.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This PA, Exploratory/Development Grants
for MH Intervention Research, is related to the priority area of Mental Health
and Mental Disorders.  Potential applicants may obtain a copy of "Healthy
People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH)
Exploratory/Development Grant R21 mechanism.  The Exploratory/Development
Grant is limited to an average of $125,000 in direct costs per year for up to
3 years.  While variations from year to year are permissible, in no case may
any year be more than $200,000 in direct costs, and total direct costs for the
entire project period may not exceed $375,000.  If less than 3 years are
requested, the maximum amount of the total direct costs may not exceed
$125,000 per year.  Individual grants are not renewable.  Annual awards will
be made, subject to continued availability of funds and progress achieved. 
Applicants with sufficient pilot data to demonstrate feasibility of an
intervention study are not eligible for this award and should pursue an
alternative grant mechanism, such as the R01.

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://www.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Summary

Exploratory/Development grants for Mental Health interventions research are
designed to support the early phases of intervention development or
adaptation, preliminary to and leading up to a full-scale (e.g., randomized
controlled, interrupted time series) trial that could take place in a clinical
or community setting.  Intervention is broadly defined to include efforts to
prevent disorder, as well as efforts to treat disorder in the acute and later
phases, such as continuation, maintenance, relapse prevention and to
rehabilitate by reducing residual symptoms and enhancing function.

Although applicants may utilize procedures that maximize internal validity
when developing new interventions, Exploratory/Development Intervention Grant
applications should state their relevance to public health intervention
approaches and outcomes.  Intervention studies with a public health focus are
designed to maximize generalizability of findings to broad populations,
providers, and settings.  They have broad sample inclusion and relatively few
exclusion criteria.  Exclusion criteria are based more on concerns for
participants' safety than on achieving tight control over extraneous sources
of variation that may complicate causal interpretations of intervention
effects.  Age, gender, and comorbidity are seen as important dimensions on
which to ensure sample representativeness and generalizability, rather than as
bases for participant exclusion.  Potential intervention outcomes are broadly
construed and evaluated, to include performance (school, work, etc.),
relationship functioning (family, interpersonal, etc.), disability, quality of
life, morbidity (including diagnostic status), mortality,
institutionalization, and health care resource use.  In developing an
intervention with public health relevance its potential application to, and
adaptation by an applied setting (e.g., specialty or primary care, school or
work-site) should be described.

Testing the effectiveness of commonly used but relatively unproven self
treatments (e.g., self-help, support groups) are encouraged.  Development of
intervention approaches applicable to understudied high risk behaviors and
events (e.g., suicide attempts, exposure to traumatic events) and understudied
mental disorders and behavioral problems (e.g., obsessive-compulsive disorder,
anorexia nervosa) is encouraged.

Intervention development can be considered to have three stages: 1)
conceptualizing an intervention approach based on theory and empirical
research, 2) developing and standardizing the intervention, and 3) pilot
testing.  This mechanism will fund research conducted at the second and/or
third stages.  (Stage 1 needs to be completed prior to submission of the
application).  Investigators are not expected to necessarily complete all
phases of intervention development during the 3-year duration of the award. 
They should propose feasible and systematic goals that can be accomplished
within the time and funding constraints of this award while considering the
final aim of completing the prerequisites for conducting a controlled study. 
The stage of the proposed work should be consistent with the stage of
scientific research thus far accomplished with regard to the population or
disorder to which it is to be applied.

Intervention standardization (Stage 2) includes components such as the
following: development of a treatment protocol, operationally defining
intervention components for use in creating a manual (e.g., psychosocial
intervention manual, initial medication dosing level), development or
adaptation of relevant measures, including diagnostic, cost and outcome
measurement); formulation of measures of provider competency, acceptance and
adherence to the protocol, and participant behavior change, acceptance and
adherence to treatment.

Pilot and feasibility studies (Stage 3) may include: testing and further
refining of initial intervention manual and measures developed during Stage 2;
gathering data to estimate intervention parameters (e.g., effect size,
attrition rates, response rates) and performing preliminary power analyses;
evaluating feasibility of procedures for implementing and evaluating the
intervention in a controlled outcome study (e.g., participant and provider
recruitment, sample definition, intervention assignment, and outcome
measures).  Sample sizes for Stage 3 should be appropriately estimated to
answer the relevant questions about the adequacy of the intervention
development, or to establish reliable estimates of intervention effect
parameters prior to trials, as applicable.

Types of Exploratory/Development Grants for Intervention Research

Interventions under consideration may be delivered independently of other
previously funded services, as an enhancement of these services, or as part of
a package of services.  Interventions may target either risk or protective
factors, or both.  Such factors may be either unique to a disorder, or common
to a number of disorders.  For preventive interventions, sample populations
may be asymptomatic, symptomatic, previously symptomatic and/or diagnosed. 
Preventive interventions may be aimed at minimizing relapse, recurrence, side
effects, or preventing comorbid symptoms or disorder.  Integrated preventive,
rehabilitative, and treatment strategies should consider the timing and
sequencing of interventions, as well as the development of incremental outcome
measures that could reflect cumulative effects of multiple interventions. 
Outcomes may be defined at the individual, group, system, or populations
levels, or any of these in combination.

The following are illustrative, but not restrictive, topics for consideration
for Exploratory/Development studies:

o  Develop approaches to defining and standardizing a credible, active
placebo, or other control treatment condition (e.g., treatment as usual),
including patient preferences, in order to improve intervention designs

o  Develop and test experimental methods for training providers, and develop
less burdensome approaches to assessing provider and participant adherence

o  Operationalize and manualize treatments that are often used but rarely
tested for effectiveness (e.g., play therapy for children with disruptive
behavior)

o  Develop off-label or innovative applications of established treatments

o  Develop novel interventions for treatment resistant patients, including
those with comorbid symptoms or disorders

o  Adapt specific interventions already established as efficacious with adults
for children and adolescents (e.g., treatments for anxiety disorders,
including PTSD)

o  Develop approaches to transporting efficacious interventions to culturally
diverse settings, including the testing of fidelity of adapted interventions

o  Determine the feasibility and likely effect size of multiple setting (e.g.,
school, family, peer, and after-school child care) interventions to prevent
symptoms or disorder and promote functional competencies

o  Propose research to determine optimal combinations of pharmacologic and
psychosocial interventions to improve functioning (e.g., psychostimulants and
psychosocial treatment of ADHD with titration of stimulants)

o  Develop family-based education, maintenance and rehabilitative strategies
that can be added and tested in conjunction with individual intervention
approaches

o  Determine the feasibility and dosing range of new or existing interventions
to prevent or minimize consequent symptoms (e.g., brief psychosocial and/or
pharmacologic treatment of trauma victims seen in emergency rooms to prevent
later PTSD)

o  Develop innovative interventions for disorders for which few efficacious
interventions exist (e.g., hypochondriasis, anorexia, trichotillomania and
other self-mutilating disorders, dissociative disorders, borderline
personality disorder, childhood feeding disorders, autism)

o  Propose methods for analyzing existing intervention data from multiple
studies as a step in developing more refined intervention approaches (e.g.,
improving fidelity, identifying predictors of response and failure, defining
alternative outcome measures)

o  Pilot test strategies to modify the physical and social aspects (e.g.,
family, community support or institutional care staff skills) of patientsþ
environments to improve symptom management and individual functioning

o  Pilot test the feasibility of interventions in practice settings and assess
the needs of stakeholders (patients, specialty providers, primary care
providers, insurance payers, employers who purchase insurance, government
provided insurance, etc.)

o  Develop and test methods for the adoption, diffusion, and long term use of
administrative and/or technical innovations in treatment or service settings

o  Develop system level interventions to improve practitioners (e.g., day care
providers, foster care cases workers, school psychologists, nurse
practitioners) abilities to provide effective care and implement indicated
interventions

o  Pilot test interventions that promote functional competence and identify
and treat early signs of disorder in high-risk groups (e.g., offspring of
parents with mental disorders or substance abuse, older persons being
transferred from acute to long-term care settings)

o  Develop innovative rehabilitative strategies to address neurocognitive
(memory, language, executive function), neuromotor (motor retardation, visuo-
motor dysfunction, perceptual (visuo-spatial, sensory integration, body image)
and homeostatic, or other regulatory deficits which contribute to functional
impairment or treatment compliance

o  Develop innovative rehabilitative interventions to address particular
strengths or plasticity

For Exploratory/Development grants, the goals of the study should be clearly
outlined and related to specific aims and procedures pertinent to whichever
phase(s) (i.e., stages 2 or 3) of intervention development will be pursued. 
It is acknowledged that boundaries between the stages outlined above are non-
discrete and therefore, investigators may propose ideas or methods including
subsets of one or more categories.  Importantly, however, the application
should include a clearly operationalized description of each component step,
with decision points indicating when each has been successfully completed and
when to move on to subsequent components.  The development of both empirically
indicated and theory-driven interventions is encouraged.  Adaptation of
existing treatments to new populations, settings, etc. is considered
innovative within a public health model.

Applications will be assigned within the National Institute of Mental Health
according to the following guidelines:

Proposals for standardizing or manualizing new non-pharmacologic
interventions, assessing safety, feasibility, and acceptability of new
interventions and collecting pilot data prerequisite for a full-scale trial of
a novel intervention will be assigned to the Division of Mental Disorders,
Behavioral Research, and AIDS.

Proposals for pilot testing existing clinical services in broader populations
(e.g., additional patient groups or disorders) or new settings, pilot testing
or refinement of existing treatments (e.g., shortened or extended periods of
treatment), standardizing protocols for routine clinical care or services, new
approaches to combining, sequencing, or timing existing interventions, and
experimental approaches to training providers to deliver proven interventions
with better fidelity, will be assigned to the Division of Interventions and
Services Research.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994 available on the web at the following URL address: 
http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets.  Only
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award.  It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules.  See
þMECHANISM OF SUPPORT,þ above, for the amounts which may be requested.  The
total direct costs must be requested in accordance with the program guidelines
and the modifications made to the standard PHS 398 application instructions
described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and
Administrative (F&A) costs] for the initial budget period Items 8a and 8b
should be completed indicating the Direct and Total Costs for the entire
proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page.  (See http://www.nih.gov/grants/funding/modular/modular.htm for sample
pages.)  At the top of the page, enter the total direct costs requested for
each year.  This is not a Form page.

o Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project.  No individual salary information should
be provided.  However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000.  List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project.  Indicate whether the collaborating institution
is foreign or domestic.  The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount. 
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A biographical sketch is required for
all key personnel, following the instructions below.  No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the initial budget period and all
future budget years.

o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further review.

The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate national
advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative?  Does the project challenge
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements?  Is there evidence of institutional
support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will also be
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications assigned to the Institute.  The following will be considered in
making funding decisions:  Quality of the proposed project as determined by
peer review, availability of funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.  See final two paragraphs under
"RESEARCH OBJECTIVES," which discuss the assignment of applications within the
National Institute of Mental Health.

Direct inquiries regarding programmatic issues to:

Peter Muehrer, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6190, MSC 9615
Bethesda, MD  20892-9615
Telephone: (301) 443-4708
FAX:  (301) 443-4611
Email: pmuehrer@nih.gov

Linda L. Street, Ph.D.
Division of Intervention and Services Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Telephone: (301) 443-1185
FAX:  (301) 594-6784
Email: Lstreet@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.242.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject to the
inter-governmental review requirements of Executive Order 12372 or Health
Systems Agency review.  Awards will be administered under PHS grants policy as
stated in the NIH Grants Policy Statement (October 1, 1998).

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, and portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

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