Subject: RFA AA-91-01 from NIH Guide 9/2l/90
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 19 Sep 90 16:36 EST

Hello Again,
  This is the third and last for today.  Please post to the NIH
Listserver as:    RFAAA-91-01.092190
      Thanks.
             Dottie
 ---------------------------- Text of forwarded message -----------------------
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Public Health Service
Alcohol, Drug Abuse, and Mental Health Administration
National Institute on Alcohol Abuse and Alcoholism
Office for Substance Abuse Prevention
 
Request for Applications
RFA:  AA-91-01
 
COMMUNITY-BASED RESEARCH ON THE PREVENTION OF
ALCOHOL-RELATED PROBLEMS
 
Application Receipt Date:  February 12, 1991
 
P.T. 34; K.W. 0404003, 0745027, 0403004, 0404000
 
(Catalog of Federal Domestic Assistance No. 13.273)
 
INTRODUCTION
 
The National Institute on Alcohol Abuse and Alcoholism
(NIAAA) and the Office for Substance Abuse Prevention (OSAP)
are sharing sponsorship of research in the area of
community-based intervention trials for the prevention of
alcohol-related problems.  NIAAA promotes prevention
research on a broad range of populations, including the
high-risk youth groups and young adults of special interest
to OSAP.  NIAAA is especially experienced in the design,
review, and monitoring of outcome-oriented research, while
OSAP has focused on the implementation of community
intervention programs and service demonstration projects.
These convergences of interest and expertise make it
mutually advantageous for NIAAA and OSAP to combine
resources to encourage and facilitate community-based
research of an appropriate scale. This joint Request for
Applications (RFA) describes the area of community-based
prevention research, indicates directions of needed
research, and discusses some design considerations.
 
The procedures for submission and review of grant
applications and the terms and conditions for grant support
are given below.  Applications received in
response to the RFA will be assigned for review and funding
consideration in accordance with established Public Health
Service (PHS) guidelines.  The statutory authorities for
these grant awards are sections 301 and 510 of the Public
Health Service Act (42 USC 241 and 290bb) and section
508(b)(10) of the Public Health Service Act (42 USC
290aa6(b)(10).  This is a collaborative effort, jointly
funded by NIAAA and OSAP.
 
BACKGROUND
 
A. The Social and Economic Costs of Alcohol-Related Problems
 
Alcohol use and abuse play a major role in numerous medical
and social problems in the United States.  Alcohol problems
do not result only from alcoholism.  The adverse
consequences of alcohol use arise as a result of single
episodes of drinking, episodic drinking, persistent alcohol
abuse, and alcohol dependence.  These consequences can
affect not only the drinker but the drinker's family,
friends, and associates, as well as others with whom the
drinker may come in contact.  Moreover, the cost to society
of the adverse outcomes of alcohol use is high.  In
addition to alcohol-involved motor vehicle crashes, alcohol
use and abuse have been linked to other types of accidental
injuries and fatalities, including drownings, falls, and
burns.  Individuals with alcohol-related problems require
more general health care, may be less productive at their
jobs than individuals who do not abuse alcohol, and are also
over-represented among criminals and persons who commit
suicide.  The negative impact that these and other alcohol
related problems have on the quality of life of society is
paralleled by considerable economic cost.
 
B.  The Public Health Model
 
The growing body of epidemiological and etiological studies
on alcohol use and abuse has led researchers to see that
alcohol problems arise through a complex interaction of
individual, interpersonal, and social factors.  This
perspective has been expressed in the public health model, a
conception of the causation of alcohol-related problems that
specifies three major elements acting together either to
produce or attenuate specific problems. These elements are:
 
o  the agent -- alcohol beverages or ethanol itself;
 
o  the individual (host) -- traits that affect a person's
susceptibility or vulnerability to the effects of alcoholic
beverages; and
 
o  the environment -- physical, interpersonal, or social
milieu surrounding the use of alcohol that either regulates
the individual's exposure to the agent or mediates the risk
that the agent poses to the individual.[1]
 
The strength of the public health perspective is that it
directs attention to interactions between the individual and
the environment that result in a specific problem. It
facilitates the development of promising interventions by
identifying different elements in the etiology of alcohol
problems to which the interventions may be directed.  It
also helps one visualize points that may be only
peripherally related to the etiology of a specific problem
but that nevertheless can be effective opportunities for
interventions.  "Whether bars and taverns cause someone to
become intoxicated, for example, is not as important as
whether they can be designed or modified to prevent
intoxication."[2]
 
The public health perspective thus provides guidance for the
development of multifaceted, integrated prevention
strategies that more closely match the complexity of alcohol
problems and the heterogeneity of drinkers and drinking
situations.
 
C.  Community-based Prevention Programs
 
Research in varied fields of health and illness has
indicated that comprehensive prevention programs informed by
the public health model can achieve significant results when
they are implemented so as to involve total communities.  In
the area of cardiovascular disease (CVD), systematic
intervention programs targeted at reducing cigarette
consumption, controlling high blood pressure, and modifying
unhealthy eating habits have resulted in community-wide
health risk reductions that can be linked to a lowered
incidence of disease and early death.
 
In general, community-based CVD
prevention programs are characterized by the following
features:
 
o  the target populations usually consist of a few
geographically or administratively defined communities;
 
o  the chief prevention strategy is to change behavior
through information and attitude change;
 
o  the chief interventions are directed at entire
populations rather than selected groups or individuals;
 
o  the health interventions are incorporated into the
existing health services system and economic structure of
the community; and
 
o  the interventions are based on community involvement and
participation and take advantage of existing social
networks.[3]
 
Brief descriptions of some of the more influential studies
appear in Appendix A.
 
Several important strategic conclusions have been drawn from
these community studies.  These are:
 
o  it is possible to change the health habits of entire
communities and to mobilize community resources to achieve
these changes;
 
o  it is possible to transfer responsibility for program
maintenance to local organizations; and
 
o  community-based intervention programs offer the
possibility of cost-effective replication of programs in
other communities.[4]
 
It should be noted, however, that the results of these
community-based studies must be interpreted with caution
because of various weaknesses in research design and
practice.  It has generally not been feasible to select the
communities studied randomly or to assign them to
interventions randomly.  In addition, it is always difficult
to control the effects of extraneous factors occurring
during the course of field research, and it is especially
problematic with long-term field studies such as these.
However, the analogous research findings of the various
studies have supported the notion that this type of
community approach may be generalizable, not only to
cardiovascular disease, but, with appropriate modifications,
to the prevention of alcohol-related problems as well.[5]
 
There are several community-level research projects focused
on alcohol-related problems. Most of these have been
directly stimulated by community research in the area of
heart disease.  Brief descriptions of some of the most often
cited studies appear in Appendix B. These studies reflect
the general state of community level prevention research in
the alcohol field.  Like the CVD studies discussed above,
this research has been limited by problems in research
design and practice, and the efforts have shown only
equivocal success.
 
Few community-based alcohol studies have adopted
environmentally oriented intervention strategies or
multifaceted, integrated strategies.  Following the CVD
community-based studies, most of the alcohol studies have
employed mass media information campaigns as their chief
strategy, sometimes combined with a secondary, supporting
strategy.  Such efforts have mainly emphasized the role of
education and training to modify individual behavior.
Extensive reviews of the alcohol and drug-related literature
have concluded that media informational and educational
programs by themselves have been largely ineffective in
preventing substance use or abuse.[6]  Although some
programs have succeeded in increasing alcohol or drug
knowledge, few have influenced attitudes and even fewer have
influenced behavior.
 
However, given the current state of the art, there are good
reasons to believe that many of the technical and strategic
limitations can be overcome and that methodologically sound,
community-based prevention research in alcohol use and abuse
can be designed and carried out.  The over-all experience
with comprehensive, community-based prevention research, in
the alcohol field as well as the heart field, justifies a
significant investment of energy and resources in such
studies in alcohol prevention research.
 
RESEARCH OBJECTIVES OF THE NIAAA/OSAP INITIATIVE
 
The primary objective of this RFA is to encourage long-term,
controlled experimentation to test community-based,
multifaceted, integrated programs for the prevention of
alcohol-related problems.  The focus of this announcement is
alcohol, but a broader perspective may facilitate this
emphasis.  In some circumstances it may be expedient to
include interventions that bear on other drug abuse as well
(e.g., the use of tobacco).
 
A.  Characteristics of the Research
 
There are two basic characteristics of community-based
research:
 
1.  Communities are the primary units of analysis; and
 
2.  Interventions are targeted at entire sectors of the
community, e.g., pregnant women, automobile drivers, and
groups or organizations such as schools or worksites.
Rates of effect would thus be calculated on a community-
based population denominator.
 
In addition to these characteristics, the research programs
envisioned here are expected to have the following
properties:
 
1.  The chief prevention strategies should be based on
environmental factors, such as:
 
o  normative factors (e.g., standards of behavior, general
attitudes and beliefs regarding alcohol, mass media
effects);
 
o  legal elements (e.g., alcohol beverage control (ABC)
laws, laws regarding driving under the influence of alcohol,
minimum purchase age laws, zoning);  and
 
o  economic factors (e.g., pricing, factors that affect the
cost of consumption).
 
The array of interventions may also include strategies that
are not considered environmental (e.g., educational programs)
even if they have not by themselves been shown to be
effective.  Such interventions may prove to be more
effective when they are combined with environmental
approaches, and they might enhance the effectiveness of the
other interventions.
 
2.  The targeted outcomes of the interventions should be
changes in the behaviors that contribute to the existence of
alcohol-related problems or changes in the incidence or
prevalence of the problems themselves.  Examples of the
former include the consumption of alcoholic beverages by
pregnant women, binge drinking, driving while intoxicated or
under the influence of alcohol, and experimental drinking by
people under the age of 21.  Examples of target problems are
alcohol-related traffic crashes, alcohol-related violence,
morbidity and mortality from alcohol-caused cirrhosis,
alcohol-related birth defects, some cancers, and alcohol
dependency.
 
3.  The target groups must include youth and/or young
adults, but need not by any means be limited to these
populations.
 
B.  Research Alternatives
 
Three distinctive community-based research alternatives are
described below.   Each of these focuses on an aspect of
community-based intervention programs that is believed to
bear directly on their effectiveness.  Option 1 refers to
programs investigating the effect of comprehensive programs,
i.e., multifaceted, integrated intervention programs.
Option 2 refers to programs assessing the effects of
integrated intervention programs.  Option 3 refers to
research investigating the influence of community
participation and involvement on the effects of intervention
programs.
 
Support will be available for research projects pursuing one
or more of these options.  Applications which do not address
one of the three options will be considered non-responsive
to the RFA and will be returned to the applicant.
Applications proposing to investigate more than one option
will probably require extra resources.  Such applications
will be considered if the potential scientific value of the
research justifies the cost.
 
The three research alternatives are as follows:
 
1.  Testing effective comprehensive programs.  A
comprehensive intervention program is one that implements
multiple interventions aimed at several outcomes.  The
objective of this option is to implement a "critical mass"
of interventions, a combination of interventions that has
the greatest anticipated effect possible with the resources
available.  The focus here is on the total effect with no
concern at this time with determining the effects of the
separate interventions.  The application should provide a
rationale for the selection of interventions and present a
reasoned estimation of the magnitude of effects expected.
 
Research using this approach should include comparisons
between communities in which the interventions were
implemented and communities in which they were not
implemented.  There should be at least two communities in
each condition.
 
2.  Assessing the interactive effects of an integrated set
of interventions.  An integrated program is one that
implements a combination of interventions targeted at the
same outcome.  For example, a set of interventions targeted
at reducing alcohol-related traffic crashes might include a
responsible server training program, strict enforcement of
driving while intoxicated and/or per se laws, and a mass
media informational campaign telling the public about the
increased enforcement.  It seems reasonable to expect that
the total impact of an integrated set of interventions will
at least equal the sum of the effects of those interventions
implemented separately.  It is possible, however, that the
combination of interventions might produce a total effect
less than the sum of the individual effects.  This may be
because the different interventions are in some degree
redundant. Or it may be that with communities, as is often
the case with individuals, there is a diminishing return or
satiation mechanism at work.
 
There is also the possibility that an integrated set of
interventions will produce synergistic effects, i.e., joint
effects that are greater than the sum of the effects of the
individual interventions.  The existence of such effects is
predicted by systems perspectives of the etiology of alcohol
problems.[7,8,9]  The rationale is that each program
component reinforces and strengthens other program
components.  There are some very encouraging results
employing computer simulation to validate a dynamic systems
model of factors determining drinking and driving and
alcohol consumption.[10]
 
At present, there appears to be no experimental research
providing answers to any of these questions in the field of
alcohol prevention research.
 
3.  The effects of community involvement.  This approach
invites research designs that employ community involvement
as an independent variable, either in a simple
present/absent design or in a more elaborate design
implementing varieties of community involvement.
 
Community involvement in the planning and delivery of
program elements is regarded as an essential facilitating
component of community-based research.[11,12,13,14]  It has
been an integral part of a number of studies, including the
influential Stanford Heart Disease Studies, and COMMIT, a
new, very large program aimed at reducing the amount of
smoking by the smoking public in general and by heavy
smokers in particular.  (The Stanford Heart Disease Studies
and COMMIT are described in Appendix A.)  However,
community involvement is not a systematically varied
experimental factor in any of these studies.  Despite the
great importance assigned to it in the literature, there
appears to be no research that treats community involvement
as an experimentally varied factor. The critical task of
research in this option will be to explicate the role of
community involvement as a causal factor in the experimental
design.
 
METHODOLOGICAL ISSUES
 
The research programs envisioned in this RFA will
investigate prevention strategies applied to entire
communities as the basic units of analysis.  In published
research reports, school districts, small cities, towns, and
regions have been considered communities for the purposes of
intervention research.  What appears to be common to the
operational conception of community is:  a definite
geographic and public identity, and a set of
administrative, political, and associational organizations
that together span the geographic entity.
 
Using communities as units of analysis poses difficulties
and challenges in the design and execution of research
programs that satisfy strong criteria of scientific merit.
Some of the more critical of these problems are discussed
below.
 
A. Design Issues
 
Research directed at assessing the impact of a prevention
strategy is inherently causal research.  Community-based
intervention trials are field experiments testing particular
intervention strategies and, as such, have to satisfy
criteria relating to internal validity.
 
The classical paradigm for causal research is the randomized
controlled experiment.  A randomized controlled experiment
may yield unbiased estimates of program effects even in the
absence of knowledge about the relationships between
exogenous variables, interventions, and mediating and
outcome variables.  Such experiments can be thought of as
"black box" research.[15]  However, black box
experimentation does not yield an understanding of
prevention programs or inform their development.  A well-
articulated theoretical framework can assist the researcher
develop and test hypotheses about mediating mechanisms and
develop or select appropriate interventions, program
evaluation procedures, and intermediate and longer term
outcome measures.[16]  Randomized experiments testing
theoretically relevant hypotheses about intervention effects
not only yield estimates of those effects but have a bearing
on the tenability of the theory as well.
 
Few reported community studies have used random assignment
of communities to intervention, and those that do have
included too few communities to achieve much protection
against alternative explanations by the procedure.  (The
project COMMIT, described in Appendix A, is one significant
exception.)  The cost in material and human resources of
community-based trials is no doubt a significant contributor
to this deficiency.  Nevertheless, randomization can be a
powerful procedure, and applicants are urged to consider its
application in community-based research.  Where it is not
feasible, other procedures such as quasi-experimental
designs and time-series analyses may provide valid
information.[17]
 
Randomization by itself does not ensure internal
validity.[18]  Strong efforts have to be made to ensure that
the compared communities do not have different histories
(except for intervention) during the course of the
experiment.  This requires comprehensive, close, and
repeated observation of all communities, experimental and
control, to document their continuing comparability and to
assist in the impact assessment of unusual or dramatic
events.[19]
 
B.  Sampling Issues
 
It is rarely feasible, on financial and other practical
grounds, to obtain random samples of communities large
enough for statistical generalization.  Researchers must
usually provide grounds other than statistical ones for
generalizing the results of a community study.  Efforts
should be made to select communities that are similar on at
least such cogent characteristics as size, cultural
tradition, demographic features, economic base, and
regulation of alcoholic beverage distribution and sales.
 
For a variety of reasons, samples of individuals within a
community might be used to obtain information in any of the
evaluation processes to be discussed below.  These samples
should be drawn by probability methods.  Using convenience
samples or allowing subjects to volunteer (select
themselves) for study vitiates statistical generalization.
Similarly, sample attrition in longitudinal studies makes it
difficult to draw accurate conclusions on statistical
grounds.  The researcher must avoid these problems or find
ways to compensate for them.
 
C.  Evaluation
 
The research plan must include comprehensive evaluation
components that are conceptually and procedurally integrated
with the over-all research program.  The three areas of
evaluation -- formative, procedural, and outcome -- provide
information relevant to the interpretation of the research
findings.  Evaluation bears directly upon the verification
of the research hypotheses connecting implementations to
outcomes.
 
1.  Formative evaluation assesses the degree to which the
instruments and procedures employed in the project have the
properties necessary for the interventions of which they are
a part.  For example, a responsible alcoholic beverage
intervention requires a training program that instructs
servers how to detect when a patron has reached a specified
limit of alcohol consumption.  The training program must be
developed and tested before it is employed in the research
program.
 
2.  Procedural evaluation refers to the periodic monitoring
of the implementation of interventions during the course of
the experiments to assure adherence to protocol and to
document what actually was being done.  Using the same
responsible server example, it is necessary to ascertain
whether the servers utilize their training effectively and
dependably on the job.  This phase of evaluation is
essential to assessing the appropriate execution of the
intervention.
 
3.  Outcome evaluation refers to observations on the
targeted outcomes, i.e., on the events and behaviors
predicted to be consequences of the various interventions.
The observations must reflect an explicit and verifiable
causal linkage between the intervention and the targeted
outcomes.  In the responsible server example, the
expectation is that patrons refused service after ingesting
a critical amount of alcohol will be less likely to be
involved in an automobile crash within an appropriate time
period after leaving the establishment.  This assumes, at
least, that at the time they leave establishments that do
and do not have responsible server programs, patrons will
have different levels of alcohol impairment.  A recent
review of server training programs indicates that all
programs were evaluated on factors relevant to this
assumption, e.g., on the impact of the training program on
servers' behavior or on their customers' consumption of
alcohol.[20]  The accident prevention effectiveness of the
intervention, however, requires other observations.  Changes
in aggregate rates of alcohol-related traffic incidents over
the life of the intervention could be used as indicators of
this aspect of intervention effectiveness.  Perhaps the most
cogent evidence would be the rates of alcohol-related
traffic incidents of these same groups.
 
D.  Measurement issues
 
The conceptualization and procedures of observation of key
variables and attributes must satisfy conventional standards
of validity and reliability.  Direct observations or
measurements are generally preferable to indirect ones, but
if the latter are employed, the causal linkage between the
surrogate measure and the target variable must be explicated
and established.
 
The consumption of alcohol is a key variable.  It is
specified as both a cause and an effect in the etiology of a
wide variety of alcohol-related problems.  Self reports are
very often used as indicators of alcohol consumption,
primarily because they have face validity and are convenient
to obtain, but there is persistent concern that they
substantially underestimate actual consumption.[21]  This
problem may be less severe in comparing individuals' reports
before and after an intervention or in subgroup comparisons,
assuming that the bias toward underestimation is reasonably
similar across groups.
 
Blood alcohol concentration (BAC) measurements are more
reliable and objective measures of consumption than self
reports, even though there may be some significant
individual response variation and error due to specific
methods of test administration.[22]  However, they cannot
substitute for self-reports in all situations, such as
retrospective accounts and large-scale surveys, for example.
 
Aggregate measures of consumption are particularly
convenient in community-based research, although they are
subject to various biases.  Alcohol sales reported for
purposes of taxation have been used as indirect estimates of
consumption in a number of studies relating price variations
to motor vehicle crash rates and cirrhosis mortality
rates.[23,24]  Indices based on reported sales are subject
to a number of biasing factors, but they appear to vary
appropriately with other relevant variables.  The Fatal
Accident Reporting System (FARS) is an often used measure of
the involvement of alcohol in traffic crashes, injuries, and
fatalities.  This approach allocates a proportion of all
crashes reported to those in which alcohol is involved, but
that proportion is an empirical estimate and requires
systematic updating.[25]
 
Community-based research programs will require research
teams with diverse experience and expertise.  Applicants
must demonstrate that the research team possesses the
methodological and technical skills requisite to carry out
community-based prevention research.  This area of research
also will require a substantial commitment of time and
resources.
 
The research plan must specify the time needed to develop
and implement the interventions and the schedule of
activities.  The research program must be scheduled to
operate long enough for the anticipated effects to have
an opportunity to occur and to give evidence as to whether
these effects are transitory or enduring.
 
ELIGIBILITY
 
Applications may be submitted by public or private nonprofit
organizations such as universities, colleges, hospitals,
research institutes and organizations, units of State or
local governments, and eligible agencies of the Federal
Government.  Women and minority investigators are encouraged
to apply.
 
INCLUSION OF MINORITIES IN STUDY POPULATIONS
 
NIAAA/OSAP requires that applicants give added attention
(where feasible and appropriate) to the inclusion of
minorities in study populations for research into the
etiology of diseases, research in behavioral and social
sciences, clinical studies of treatment and treatment
outcomes, research on the dynamics of health care and its
impact on disease, and appropriate interventions for
disease prevention and health promotion.  If minorities are
not included in a given study, a clear rationale for their
exclusion should be provided.
 
INCLUSION OF WOMEN IN STUDY POPULATIONS
 
NIAAA/OSAP requires that applicants consider the inclusion
of women in the study populations for all clinical research
efforts.  Exceptions would be studies of diseases which
exclusively affect males or where involvement of pregnant
women may expose the fetus to undue risks.  Gender
differences should be noted and evaluated.  If women are not
to be included, a clear rationale should be provided for
their exclusion.
 
In order to provide more precise information to the
treatment community, it is recommended that publications
resulting from NIAAA/OSAP-supported research in which the
study population was limited to one sex for any reason other
than that the disease or condition studied exclusively
affects that sex, should state, in the abstract summary, the
gender of the population studied, e.g., "male patients,"
"male volunteers," "female patients," "female volunteers."
 
APPLICATION RECEIPT AND REVIEW SCHEDULE
 
Receipt         Initial        Advisory         Earliest
Date            Review      Council Review     Start Date
 
Feb. 12, 1991   May/June 1991   Sept. 1991       Sept. 1991
 
Applications received after the specified receipt date will
be returned to the applicant.
 
APPLICATION PROCESS
 
Applicants should use the grant application form PHS 398
(revised 10/88).  The number and title of this
RFA, "AA-91-01, Community-Based Research on
the Prevention of Alcohol-Related Problems," should be typed
in item number 2 on the face page of the PHS 398 application
form.
 
When using the PHS 398 application form to respond to an
RFA, applicants must affix the RFA label, available in the
application kit, to the bottom of the face page.  Failure to
use this label could result in delayed processing of the
application, such that it may not reach the review committee
in time for review.
 
Application kits containing the necessary forms and
instructions may be obtained from business offices or
offices of sponsored research at most universities,
colleges, medical schools, and other major research
facilities.  If such a source is not available, the
following office may be contacted for the necessary
application material:
 
National Clearing House for Alcohol and Drug Information
Post Office Box 2345
Rockville, MD  20852
Telephone:  (301) 468-2600
 
The signed original and six (6) legible copies of
the completed application should be sent to:
 
Division of Research Grants, NIH
Westwood Building, Room 240
Bethesda, MD  20892**
 
REVIEW PROCEDURES
 
The Division of Research Grants, NIH, serves as the central
point for receipt of applications under this RFA.
Applications received will be assigned to the Initial Review
Group (IRG) in accordance with established Public Health
Service Referral Guidelines.  The IRG, consisting primarily
of non-Federal scientific and technical experts, will review
applications for scientific and technical merit.
Notification of the review recommendations will be sent to
the applicant after the initial review.  Applications will
receive a second-level review by the National Advisory
Council on Alcohol Abuse and Alcoholism and the Advisory
Committee on Substance Abuse Prevention, where reviews may
be based on policy considerations as well as scientific
merit considerations.  Only applications recommended for
approval by these advisory bodies may be considered for
funding.
 
Applications submitted in response to this announcement are
not subject to the intergovernmental review requirements of
Executive Order 12372, as implemented through the Department
of Health and Human Services regulations at 45 CFR Part 100,
and are not subject to Health Systems Agency review.
 
REVIEW CRITERIA
 
Criteria to be used in the scientific and technical review
of applications will include the following:
 
o  potential contribution of the proposed research to
enhancing the scientific basis of community-based alcohol
abuse prevention programs;
 
o  significance of the proposed research for the
objectives, options, and characteristics of research
identified above;
 
o  inclusion of youth and/or young adults as one of the
targeted populations;
 
o  evidence that the investigators are familiar with the
state-of-the-art and existing knowledge gaps in their
proposed area of study;
 
o  degree of scientific rigor in the design and
implementation of the study;
 
o  responsiveness to the design issues discussed above;
 
o  adequacy of the methodology proposed to collect and
analyze data;
 
o  qualifications and research experience of the principal
investigator and other key research personnel;
 
o  availability of adequate facilities, other resources, and
collaborative arrangements necessary for the research,
including evidence of community cooperation;
 
o  appropriateness of budget estimates for the proposed
research activities; and
 
o  adequacy of provisions for the protection of human
subjects.
 
AWARD CRITERIA
 
Applications recommended for approval by the appropriate
advisory bodies will be considered for funding on the basis
of the overall scientific and technical merit of the
proposal as determined by peer review, NIAAA/OSAP program
needs and balance, and the availability of funds.
 
TERMS AND CONDITIONS OF SUPPORT
 
Grant funds may be used for expenses clearly related and
necessary to carry out research projects, including both
direct costs, which can be specifically identified with the
project, and allowable indirect costs of the institution.
Research grant support may not be used to establish, add a
component to, or operate a prevention, rehabilitation, or
treatment service program.  Support for research-related
prevention, rehabilitation, or treatment services and
programs may be requested only for costs required by the
research.  These costs must be justified in terms of
research objectives, methods, and designs that promise to
yield generalizable knowledge and/or make a significant
contribution to theoretical concepts.
 
In order to expand a research project to more communities or
to increase the number or complexity of the interventions to
be tested, applicants may wish to seek additional funding
from public or private agencies.  If the research budget is
to be supplemented by funds from sources other than NIAAA
and OSAP, the application must provide documentation of the
availability of these funds.
 
Grants must be administered in accordance with the PHS
Grants Policy Statement (Rev. January 1, 1987), which should
be available from your office of sponsored research.
 
Federal regulations at Title 42 CFR Part 52, "Grants for
Research Projects," and Title 45 CFR Parts 74 and 92,
generic requirements concerning the administration of
grants, are applicable to these awards.
 
PERIOD OF SUPPORT
 
Applicants may request up to 5 years of support (renewable
for subsequent periods).  Annual awards will be made subject
to availability of funds and progress achieved.  A competing
supplemental application may be submitted during an approved
period of support to expand the scope or protocol of a
project during the approved period.  A competing
continuation (i.e., renewal) application may be submitted
before the end of an approved period of support to continue
a project.
 
AVAILABILITY OF FUNDS
 
Applications submitted in response to this announcement will
compete for approximately $2,000,000 in new grant money that
is expected to be made available for this purpose in fiscal
year 1991.  It is anticipated that one to three projects
will be supported.
 
FINAL REPORT REQUIREMENTS
 
Grantees are expected to submit an original and two copies
of the final report of their project to NIAAA within 90 days
of the project's termination.  The final report should
contain at least the following:
 
o  a literature review;
 
o  a clear statement of purpose and methodology;
 
o  the findings of the project;
 
o  an interpretation and discussion of those findings,
including a clear exposition of their relevance to the
prevention of alcohol-related problems and their
implications for further research;
 
o  a description of dissemination achieved or planned;
 
o  a summary or abstract of the report.
 
CONSULTATION AND FURTHER INFORMATION
 
Potential applicants are encouraged to seek preapplication
consultation.  For information on preparing an application
under this announcement, please contact:
 
S. Frank Camilleri, Ph.D.
Prevention Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 13C-23
Rockville, MD  20857
Telephone: (301) 443-1677
 
APPENDICES:  EXAMPLES OF COMMUNITY-BASED PREVENTION
RESEARCH
 
These brief summaries of research are included to provide
applicants with an introduction to the more influential
research literature.
 
Appendix A:  Examples from Heart Disease and Cancer
Research.
 
1.  The North Karelia Project.[26]  One of the earliest and
most influential community-based intervention programs was a
research program for health promotion in North Karelia,
Finland, a rural county with a population of 180,000 in
eastern Finland.  The aims of the program were to improve
detection and control of hypertension, reduce smoking,
and promote diets lower in saturated fat and higher in
vegetables and low-fat products.  Most of the program was
implemented between 1972 and 1977.
 
Of special relevance here, the health problem was defined
and dealt with as a community problem rather than one
affecting only high-risk individuals, and the project worked
together with county and local health officials to
reorganize the way hypertension was detected and treated.
The project included an information campaign that involved
the cooperation and mediation of opinion leaders from both
formal and informal groups:  for example, members of a local
housewives' association were encouraged and instructed in
how to prepare healthier types of meals.  Outcome evaluation
procedures included baseline and follow-up (five years
later) cross-sectional sample surveys of North Karelia
inhabitants and a matched reference community.  Smoking, for
example, was measured by a standard set of questions
validated at the follow-up survey by corroborative physical
measures (analysis of the serum thiocyanate levels) of a
random half of the subjects.  Significant changes in risk
estimates for the targeted elements were observed in North
Karelia when compared to the reference area.[27]
 
2.  The Stanford Studies.[28]  Also in 1972, a team of
researchers at Stanford University began a cardiovascular
disease (CVD) prevention research program involving several
communities in California.  Their first study, The Three
Community Study, implemented mass media and intensive,
face-to-face education programs in one experimental
community and a mass media program alone in a second
community over a period of three years.  A third community
served as a control.  Both media and media plus face-to-face
instruction had significant effects on most outcome
variables.  The estimated net difference between control and
treatment samples in a composite measure of risk for
cardiovascular disease was 23-28%.  The combined
interventions (mass media plus face-to-face) were somewhat
more effective than mass media alone in increasing knowledge
and reducing smoking, but not in affecting other outcome
variables.  This study served primarily as a pilot test for
the second study, The Five City Project (FCP).[29]
 
The FCP is an ongoing, 13-year study that began in 1978.  It
involves 350,000 people in five communities and employs
multiple methods of education and community organization.
The primary goal of the FCP is to reduce the risk of
cardiovascular disease.  Among its other goals, the ones
most significant here, are those of developing community
organization methods and of transferring control and
maintenance of the program to community organizations.  CVD
risk for total mortality and for coronary heart disease
events was reduced significantly in treatment communities as
measured in four time periods from two to 5-1/3 years after
education began.
 
3.  The Minnesota Heart Health Program.[30]  This is a
research and demonstration project of community health
education designed to reduce the risk of CVD.  A
comprehensive educational program modeled after the North
Karelia and Stanford studies was implemented in three
communities using multiple media channels and withheld in
three comparison communities.  Surveillance is carried out
in annual population surveys with periodic cohort studies.
The program is carried out by a local staff and a community
advisory board with campaign task groups in each educated
community.  The program began in 1981 and is designed for a
nine-year period.
 
4.  The Pawtucket Heart Health Program.[31]  A continuing
project first funded in 1980, the project has utilized a
community activation approach to major levels of the
community (individual, small group, organization, and
community) and placed major emphasis upon the involvement of
community volunteers in delivery of intervention components.
 
The objective of the study is to prevent atherosclerotic
heart disease by modifying behaviors (smoking, cholesterol
elevating diets, high blood pressure, obesity, physical
inactivity, and stress) that increase the risks of the
development of the disease.
 
The overall outcome evaluation is based in part on biennial
cross-sectional random sample surveys of subjects in the
intervention city and a comparison community.  The surveys
concentrate on risk factor changes and physiological
assessment (blood sample and expired air analyses, and
physical fitness). A baseline survey, completed in 1982, has
been converted into a cohort with a second measurement being
completed in 1987 and a third scheduled for completion in
1990.[32]
 
5.  COMMIT.[33]  On September 30, 1986, the National Cancer
Institute launched a massive, highly structured research
program, the Community Intervention Trial for Smoking
Cessation (COMMIT).  The project entails working with
communities across North America to examine methods of
getting smokers to quit, especially those who smoke 25 or
more cigarettes per day.  Eleven matched pairs of
communities -- one community per pair for intervention and
the other for comparison -- are involved in the research
project.  The project consists of three phases (planning
and development, community implementation, and analysis and
reporting) that will continue through 1994.
 
As a research study, COMMIT requires the implementation of a
standardized intervention process.  A central feature of
this process is the formation of a Community Board at each
intervention site to work with the research institution to
decide how to carry out the activities specified in the
protocol, who should carry them out, and how best to use the
available resources.  Task forces are to be formed in each
community to organize and implement activities in their
areas.  A "public education" task force is charged with
sponsoring media advocacy training, developing communication
networks, developing and conducting public events,
encouraging policy changes, monitoring smoking regulations,
and facilitating prevention efforts. A major goal of this
group is to promote social action that leads to a smoke-free
community.  A "health care providers" task force will
coordinate activities that train and encourage health care
professionals to take an active role in smoking cessation
efforts.  A major goal of this group is having all health
care facilities adopt and effectively implement policies to
become smoke-free.
 
A "worksites and organizations" task force has the
responsibility of identifying ways to promote smoking
control activities in worksites and other organizations.
One of its major goals is to increase quitting rates among
workers and organization members who smoke.  The "cessation
resources and services" task force will organize and
coordinate the delivery of smoking cessation services such
as cessation materials and classes.  A major goal of this
group is to assist smokers in identifying available
assistance when they attempt to quit smoking.
 
Appendix B:  Examples from Alcohol Abuse Research.
 
1.  Project CRASH.[34]  A public education mass media
campaign, Project CRASH (Countermeasures Related to Alcohol
Safety on the Highways), was conducted in Vermont between
1972 and 1974.  The program objectives were to increase
knowledge and to modify attitudes and behavior so as to
reduce the incidence of alcohol-impaired driving.  The mass
media campaign was conducted in one geographical test area
in the state along with a countermeasure that consisted in
deploying eight extra state troopers throughout four
counties.  In another area the campaign was conducted by
itself, and a third (control) area received neither media
campaign nor the countermeasure.  There were no efforts made
to involve elements of the community in the program
activities. The media campaign was evaluated by a series of
roadside surveys conducted in both test areas and in the
comparison area.  A breath alcohol determination was
obtained at the roadside interviews.  The program appeared
to be modestly successful in increasing knowledge and
affecting attitudes.  It appeared to be somewhat successful
in reducing the incidence of high-risk respondents driving
with impairing blood alcohol concentrations (BACs).  Changes
in the proportion of alcohol-related fatal crashes to total
fatal crashes could not be reliably attributed to the
campaign because of uncontrollable environmental factors
(particularly a gasoline shortage during the second year).
 
2.  The "Winners" Program.[35]  The California Prevention
Demonstration program  was begun in 1978.  The interventions
included mass media messages designed to increase awareness
of the dangers of alcohol and to change attitudes toward
alcohol.  These interventions, it was hoped, would lead to
changes in drinking behavior.  The media materials were
developed around a positive theme of "Winners Quit While
They're Ahead" and targeted to a variety of populations.
The program was implemented in two experimental sites in the
San Francisco-Oakland East Bay Area.  The primary site,
approximately one-half of Oakland and all of San Leandro,
was subject to moderation-in-drinking messages disseminated
through mass media and to community organization and
development activities.  The secondary site received only
the mass media messages.  The comparison site, Stockton,
received no special prevention activities.  Unfortunately,
budget cuts in midstream curtailed the evaluation component,
and political intervention prohibited types of media
messages felt to be effective but deemed unacceptable by the
State of California, which sponsored the program.
 
Overall program effects were limited.  There was an increase
in awareness of alcohol-related messages, but levels of
concern about the dangers of alcohol remained generally
constant.  There was some increase in knowledge about
alcohol and its effects among adults, and to a lesser extent
among youth, in the primary site.  No indication of
significant attitude or behavior change was evident.[36]
 
3.  The Rhode Island Alcohol Abuse/Injury Prevention
Project.[37]  This project was instituted in 1984 as a five-
year community prevention trial to develop and test
interventions to reduce the incidence of some of the most
dangerous drinking-related behaviors.  Three Rhode Island
cities were selected for the project based on size,
incidence of alcohol-related health problems, socio-
demographic characteristics, and community resources. The
demonstration community was chosen at random from among
these. The other two were used as comparisons.  The
intervention strategy was directed at changing the
knowledge, attitudes, and enabling behaviors of gatekeepers
in their occupational roles as regulators of community
drinking practice.  For example, a person who protects
his/her spouse from some of the consequences of their
alcohol abuse, or an alcoholic beverage server who gives an
intoxicated person "just one more drink," is seen as
facilitating or enabling the abusive drinking.
 
The three main intervention efforts included community
mobilization, responsible alcohol server training, and more
intensive and visible law enforcement.
 
Several process indicators suggest that the gatekeepers
responded appropriately to the interventions.  A majority of
servers participated in the training, and a post-test done
twelve to eighteen months after the training shows enduring
changes in attitudes and behavior.  The police carried out a
vigorous enforcement campaign.  Alcohol-related arrests
increased in the intervention community while in the two
comparison communities they held level or decreased.  The
impact of the project on alcohol-related accidents is
unclear.  In the first year of the project, the rate of
alcohol-related accidents increased in the intervention
community, while in the comparison communities, it remained
unchanged or decreased.  It was not possible to disentangle
genuine prevention effects from improved reporting and from
some extraneous events.[38]
 
4.  The Tri-Community Prevention Project.[39]  The project
was conducted on three small communities in Ontario, Canada,
in the early 1980's.  The key objective of the study was to
determine whether a change in the proportion of heavy users
of alcohol has a measurable impact on the overall
distribution of consumption, in particular whether a shift
in drinkers from the heavier to the lighter end of the
consumption curve was accompanied by a comparable shift in
the consumption patterns of lighter drinkers.  The
interventions were educational/counselling programs aimed
primarily at heavy drinkers, but the project included some
efforts at stimulating community organizational involvement
in the problems of heavy drinking.
 
Although relatively few heavy drinkers participated in the
counselling and educational component of the intervention,
it appears that on average there was a reduction in alcohol
consumption in the course of their participation.  However,
as measured by self reports, the consumption patterns of one
intervention community and the control community did not
change appreciably over the period of study, nor were there
evident substantial changes in the rates of alcohol-related
problems such as drinking-and-driving incidents.
 
5.  The New Zealand study.[40]  In 1982, a community-based
intervention program was initiated in New Zealand to
reinforce moderate drinking patterns.  The interventions
included a media campaign and the use of community
organizers to stimulate public and open discussion of
alcohol policy issues.  Change was monitored in six cities:
two cities with an alcohol-focused community organizer and
media campaign, two cities with the media campaign only, and
two reference cities that received no intervention.  The
organizers focused on alcohol availability and pricing
policies.  The media campaign focused on reducing large
quantity drinking by young men.  The program effects were
confounded with national trends, but the results of a survey
suggest some change in community attitudes toward the
program's policy objectives.
 
6.  The Vermont study.[41]  In the early 1980's, a community
education program was designed to train individual drinkers
to regulate their own blood alcohol concentration below a
level of impairment (.05g/dl).  The education program
included a series of meetings with community leaders, a
system through which drink calculators were distributed and
demonstrated to community members through licensed alcoholic
beverage outlets, and broadcast of public service television
spots in which use of calculators was demonstrated.  Program
components were evaluated in three matched Vermont
communities:  one receiving the full community education
program, one receiving TV spots only, and one serving as
control.  Results suggest that the media messages alone had
the effect of deterring the consumption of any alcohol
before driving, but the effect was stronger when the
messages were combined with the community program.
 
7.  The Midwestern Prevention Project (MPP, also referred to
as Project STAR).[42]  This is a recent and ambitious
community drug intervention project that includes the
prevention of alcohol problems.  MPP is a multilevel program
addressing individual, social, and environmental factors
thought to influence adolescent drug use.  The program was
implemented first in 1984 in 50 schools in 15 communities
that comprise Kansas City, Kansas, and Kansas City,
Missouri.  The program components, delivered from
September 1984, through January 1986, consisted of a 10-
session youth education program on skill training for
resistance of drug use, 10 homework sessions involving
active interview and role-plays with parents and family
members, and mass media coverage.  Mass media coverage was
offered each year of the program but was not experimentally
controlled.  The other prevention program components were
added sequentially, at the rate of one a year, in an effort
to assess the separate and aggregate effects of combinations
of interventions.  The program has been repeated in
Indianapolis, Indiana, in an effort to test its efficacy and
replicability.  The project has reported significant
reduction in the use of tobacco, marijuana, and alcohol in
both sites.[43]  A full report is expected in 1991,
following completion of the Indiana phase.
 
REFERENCES
 
1.  Wallack, L., Alcohol advertising reassessed: the public
health perspective, in M. Grant, M. Plant, and A. Williams
(eds), Economics and Alcohol:  Consumption and Controls
(London and New York: Gardner Press), 1983, pp. 243-248.
 
2.  Prevention and Treatment of Alcohol Problems:  Research
Opportunities (Washington, D.C.: National Academy Press),
1989, p.24.
 
3.  Salonen, J.T., T.E. Kottke, D.R. Jacobs, Jr., and P.J.
Hannan, Analysis of community-based cardiovascular disease
prevention studies -- evaluation issues in the North Karelia
Project and the Minnesota Heart Health Program,
International J. Epidemiology 15:176-182, 1986.
 
4.  Farquhar, J.W., The community-based model of life style
intervention trials, Am. J. Epidemiology 108:103-111, 1978.
 
5.  Prevention and Treatment of Alcohol Problems, p. 128.
 
6.  Moskowitz, J.M., The primary prevention of alcohol
problems: a critical review of the research literature,
J. Studies on Alcohol 50:54-88, 1989.
 
7.  Room, R., Alcohol control and public health, in L.
Breskow, J.E. Fielding, and L.B. Lave (eds), Annual Review
of Public Health 5:293-317, 1984.
 
8.  Holder, H.D. and L. Wallack, Contemporary perspectives
for preventing alcohol problems: an empirically derived
model, J. Pub. Health Policy, Autumn:324-339, 1986.
 
9.  Holder, H.D. and N. Giesbrecht, Concepts and issues for
community-based action to prevent alcohol and other drug-
related problems. Paper read at the Symposium on Experiences
with Community Action Projects for the Prevention of Alcohol
and Other Drug Problems, Scarsborough, Ontario, Canada,
March 11-16, 1989.
 
10.  Holder, H.D. and J.O. Blose, Reduction of community
alcohol problems: computer simulation experiments in three
counties,  J. Stud. Alcohol 48:124-135, 1987.
 
11.  Farquhar, J., N. Maccoby, and P. Wood,  Education and
communication strategies, in W. Holland, R. Detels, and G.
Knox (eds), Oxford Textbook of Public Health, Vol. 3
(London: Oxford Press), 1985, pp. 207-221.
 
12.  Tuchfeld, B.S. and S.H. Marcus, Social models of
prevention in alcoholism, in J. Matarazzo, et al.,
Behavioral Health:  A Handbook of Health Enhancement and
Disease Prevention (New York: John Wiley and Sons), 1984.
 
13.  Pentz, M.A., C. Cormack, B. Flay, W.B. Hansen, C.A.
Johnson, Balancing program and research integrity in
community drug abuse prevention: Project STAR approach, J.
School Health 56:389-393, 1986.
 
14.  Kelly, J.G., A Guide to Conducting Prevention Research
in the Community: First Steps (New York: The Hayworth
Press), 1988.
 
15.  Chen, H. and P.H. Rossi, Evaluating with sense:  the
theory driven approach, Evaluation Review 7:283-302, 1983.
 
16.  Prevention and Treatment of Alcohol Problems, p.112.
 
17.  Reichardt, C.S., Estimating the effects of community
prevention trials.  Paper prepared for the National
Invitational Conference "Methodological Issues in Community
Prevention Trials for Alcohol Problems," University of
California, Berkeley, December 4-5, 1989.
 
18.  Cook, T.D. and D.T. Campbell, Quasi-Experimentation:
Design and Analysis Issues for Field Settings (Boston:
Houghton Mifflin), 1979.
 
19.  Reichardt, C.S. and H.F. Gollob, Ruling out threats to
validity, Evaluation Review 13:3-17, 1989.
 
20.  Saltz, R.F., Research needs and opportunities in server
intervention programs, Health Education Quarterly 16:429
438, 1989.
 
21.  Midanik, L., The validity of self-reported alcohol
consumption and alcohol problems: a literature review,
British J. Addiction 77:357-382, 1982.  See also Fuller,
R.K., K.K. Lee, and E. Gordis, Validity of self-report in
alcoholism research: results of a veterans administration
cooperative study,  Alcoholism: Clinical and Experimental
Research 12:201-205, 1988.
 
22.  Hume, D. and E. Fitzgerald, Chemical tests for
intoxication: what do the numbers really mean?  Analytical
Chemistry 57:876A-886A, 1985.  See also Jones, A., How
breathing techniques can influence the results of breath
alcohol analysis, Medical Science and Law 22:275-280, 1982.
 
23.  Saffer, H. and M. Grossman, Beer taxes, the legal
drinking age, and youth motor vehicle fatalities, J. Legal
Studies 16:351-374, 1987.
 
24.  Cook, P.J. and G. Tauchen, The effect of liquor taxes
on heavy drinking, Bell J. Econ. 13:379-390, 1982.
 
25.  Ravenholt, R.T., Addiction mortality in the United
States, 1980: tobacco, alcohol, and other substances,
Population and Development Review 10:697-742, 1984.
 
26.  Puska, P., J. Salonen, A. Nissinen, and J. Tuomilehto,
The North Karelia Project, Preventative Medicine 12:191 195,
1983.
 
27.  McAlister, A. et al., Theory and action for health
promotion: illustrations from the North Karelia Project,
AJPH 72;1:43-50, 1982.
 
28.  Farquhar, J.W., et al., Community education for
cardiovascular health, Lancet 1:1192-1195, 1977.
 
29.  Farquhar, J.W., et al., The Stanford five-city project:
design and methods, Amer. J. of Epidemiology 122:323-334,
1985.
 
30.  Blackburn, H.,  et al., The Minnesota Heart Health
Program:  a research and demonstration project in
cardiovascular disease prevention, in J.D. Matarazzo, et
al., op. cit., pp. 1171-1178.
 
31.  Lasater, T., et al., Lay volunteer delivery of a
community based cardiovascular risk factor change program:
the Pawtucket experiment, in J.D. Matarazzo et al., op.
cit., pp. 1166-1170.
 
32.  Lasater, T., Community designs employed in heart
disease and cancer prevention projects.  Paper prepared for
the National Invitational Conference "Methodological Issues
in Community Prevention Trials for Alcohol Problems,"
University of California, Berkeley, California, December
4-5, 1989.
 
33.  COMMIT: Protocol Summary.  National Cancer Institute,
Bethesda, Maryland, 1988.
 
34.  Worden, J.K., J.A. Waller, and T.J. Riley, The Vermont
Public Education Campaign in Alcohol and Highway Safety:  A
final review and evaluation.  CRASH Report I-5 (Montpelier,
Vermont), 1975.
 
35.  Wallack, L.M. and D.C. Barrows, Preventing Alcohol
Problems in California: Evaluation of the Three-Year
"Winners" Program, Social Research Group, School of Public
Health, University of California, 1981.
 
36.  Ibid., p.171.
 
37.  Speare, M.C. and S.L.Buka, The Rhode Island
alcohol/injury prevention project, in Evaluating Community
Prevention Strategies.  Papers prepared for a conference in
San Diego, California, January 11-13, 1990.
 
38.  Stout, R. L., Prevention experiments in the context of
on going community process:  opportunities or obstacles for
research.  Paper prepared for the National Invitational
Conference "Methodological Issues in Community-Prevention
Trials for Alcohol Problems," University of California,
Berkeley, December 4-5, 1989.
 
39.  Giesbrecht, N., and A. Pederson, General populations,
alcohol-related problems or high-risk drinkers as foci in
community-oriented prevention projects.  Paper prepared for
the National Invitational Conference " Methodological Issues
in Community Prevention Trials for Alcohol Problems,"
University of California, Berkeley, December 4-5, 1989.
 
40.  Casswell, S. and L. Gilmore, An evaluated community
action project on alcohol, J. Studies on Alcohol
50:339-346, 1989.
 
41.  Worden, J.K., et al., Preventing alcohol-impaired
driving through community self-regulation training, Amer. J.
Public Health 79:287-290, 1989.
 
42.  Pentz, M.A. et al., A multicommunity trial for primary
prevention of adolescent drug abuse, JAMA 261:3259-3266,
1989.
 
43.  Pentz, M.A. Unpublished results presented to an
audience at NIAAA, Rockville, Maryland, February 1990.