Full Text PA-96-019
 
INTERVENTION RESEARCH TO PREVENT ALCOHOL-RELATED PROBLEMS
 
NIH GUIDE, Volume 25, Number 2, February 2, 1996
 
PA NUMBER:  PA-96-019
 
P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  Disease Prevention+ 
  Therapy Evaluation 

 
National Institute on Alcohol Abuse and Alcoholism
 
PURPOSE
 
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks
to stimulate the design, development, and/or testing of interventions
that have the potential of preventing alcohol abuse and
alcohol-related problems among appropriate target populations.
Investigators are encouraged to move beyond preintervention studies
into the domain of efficacy and effectiveness studies that directly
assess the impact of preventive interventions.
 
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 program
announcement, Intervention Research to Prevent Alcohol-Related
Problems, is related to the priority areas of alcohol abuse reduction
and alcoholism prevention.  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 202-783-3238).
 
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.
Foreign applicants are not eligible for First Independent Research
Support and Transition (FIRST) Awards (R29).  Research Project Grant
(R01) applications from foreign institutions are limited to three
years.
 
MECHANISM OF SUPPORT
 
Research support may be obtained through applications for a regular
research project grant (R01), First Independent Research Support and
Transition (FIRST) Award (R29) or Small Grant (R03).  Applicants may
also submit Investigator-Initiated Interactive Research Project
Grants (IRPG) under this program announcement.  Interactive Research
Project Grants require the coordinated submission of related regular
research project grant (R01) applications and, to a limited extent,
FIRST Award applications from investigators who wish to collaborate
on research, but do not require extensive shared physical resources.
Further information on the IRPG mechanism is available in program
announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24,
No. 35, October 6, 1995.Program Project Grants applications (P01)
will not be accepted under this program announcement.  Investigators
who wish to submit an application that exceeds $500,000 for direct
costs in any one year must contact program staff before submitting an
application.
 
FUNDS AVAILABLE
 
The NIAAA estimates that the average research project grant award
size will be approximately $250,000 in total costs per year.
Although the financial plans of NIAAA provide for the support of this
program, the award of grants pursuant to this announcement is
contingent upon the availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Intervention and prevention strategies may be initiated and
implemented by the investigators themselves for the specific purpose
of testing their effects; or the interventions may occur naturally
outside the control of the investigator, through actions of public
and private organizations.  Studies of naturally occurring
interventions are called "natural experiments."  It may be possible
to nest an investigator-initiated intervention within a natural
experiment, permitting effects of both types of interventions to be
studied simultaneously.  Thus, investigators might develop and test
an intervention like media advocacy or physician guidance that calls
attention to and helps implement a new law or policy for preventing
alcohol abuse.
 
Applicants should justify their choice of interventions for study
based on relevant theories of behavioral change for individuals or
groups and, where possible, on existing data suggesting positive
intervention effects.  Although natural experiments tend to be
empirically-rather than theory-driven, the applicant should still
explain why the chosen intervention should (or should not) be
expected to have a preventive effect.
 
Applicants may propose small-scale feasibility or pilot studies as a
prelude to later designing more complex intervention research.
Feasibility studies might address the following types of issues:
determining ways to ensure effective recruitment, retention,
compliance, and followup of representative study participants (e.g.,
parents, ethnic minorities, school drop outs); operationalizing
interventions for use in real-world environments; determining the
acceptability of intervention and data collection protocols by
necessary gatekeepers and target groups; developing and testing
procedures for training intervention implementors and data
collectors; constructing or adapting protocols for use among
culturally diverse populations; determining how necessary outcome
data can be most effectively, efficiently, and completely collected.
 
Examples of Investigator-Initiated Interventions include, but are not
limited to:
 
College-Based Studies:  There is a paucity of attempts to develop and
test strategies to reduce drinking, binge drinking, and
alcohol-related problems on college campuses.  Interventions
currently being tested include brief motivational counseling and
challenging of alcohol expectancies.  Applicants are encouraged to
expand the breadth of strategies being tested, to focus on high-risk
groups, to consider approaches to normative change, and to
collaborate with college administrators in designing and implementing
prevention policies to be studied.
 
Worksite Studies:  Recent preintervention studies of work-related
alcohol problems and policies have laid the groundwork for tests of
new and modified primary prevention strategies among unionized and
nonunionized workers and managers in a range of work settings.
Studies of the effectiveness of secondary prevention approaches for
early detection of problems and appropriate referral (e.g., through
EAPs) are also encouraged.  Interventions may attempt to change
formal and informal alcohol policies, organizational goals, work
environments, work-group norms, and/or perceptions, beliefs, and
attitudes of individuals.
 
Family Studies:  Data suggest that family involvement can enhance the
effectiveness of school-based prevention programs.  Moreover,
family-focused interventions may themselves reduce alcohol-related
problems among youth and adults, including elderly family members.
This is an underdeveloped area of alcohol prevention research that
needs systematic expansion.  Studies may focus on families in general
or those at high risk for alcohol problems.  Applicants should
attempt to develop and test strategies that could ultimately prove to
be cost-effective. Labor-intensive interventions should be justified
by the magnitude of the problem being prevented.
 
Health-Care Systems:  Increasing attention is being given to the
possible role of health-care systems and professionals in preventing
alcohol-related problems before they occur and in facilitating the
early detection of problematic drinking.  Experimental and
quasi-experimental designs may be used in health-care settings to
test the efficacy of preventive strategies.  These may include
various forms of advice, monitoring, and risk assessment (e.g.,
anticipatory guidance for teenagers and pregnant women, medication
counseling for the elderly).
 
Alcohol and AIDS:  Numerous studies have determined that alcohol is
an important co-factor in increased risk of HIV infection.
Applicants are encouraged to develop and test single or multiple
interventions that target populations in which alcohol use or misuse
contributes to HIV risk behaviors.  These interventions can be aimed
at individuals, social networks, and/or social institutions to change
alcohol/sexual expectancies, behavioral norms, and risky behaviors.
 
Alcohol-Related Violence:  Existing studies show two-way
relationships between alcohol use and physical and sexual violence.
Research indicates that victims of child abuse are at excess risk of
developing alcohol problems later in life and that abusers of alcohol
may be at increased risk of perpetrating violence against others.
Few attempts have been made to design and test interventions to
prevent alcohol- related violence.  Such strategies could target
potential perpetrators or victims of violence (e.g., partners of
alcohol abusers), drinking establishments and hazardous environments
(e.g., student vacation sites), or alcohol-availability policies.
 
Alcohol-Related Birth Defects:  NIAAA supports a large portfolio of
grants concerned with biomedical and epidemiological aspects of fetal
alcohol syndrome (FAS) and other alcohol-related birth defects.
However, only a small proportion of NIAAA studies have addressed
prevention issues.  Since fetal alcohol syndrome is the largest
preventable cause of mental retardation, there is a compelling need
for studies that develop and test interventions that have the
potential of reducing rates of FAS among high-risk populations.
Heavy-drinking women in the child bearing years are an especially
important target group.
 
Genetic/Behavioral Risk Counseling:  Vulnerability to alcoholism and
alcohol problems reflects a complex interaction of genetic,
behavioral, and environmental factors.  Mechanisms and modes of
inheritance may differ for various subtypes of the illness or
condition.  The time has come to explore the possible benefits of
counseling for high-risk families that takes into account aggregate
familial risk factors including genetics.  Such interventions should:
be developmentally age appropriate, address the initiation and
progression of drinking, deal with mediating behavioral processes and
family dynamics, and avoid misattribution, labeling, and
stigmatization.  Outcome measures could assess changes in risk
perceptions, attitudes, and behaviors of target individuals and
families.
 
Media/Communication Strategies:  Previous research suggests that
media interventions alone are relatively weak prevention strategies,
but they clearly can be an important adjunct to other community
initiatives such as road blocks and zero tolerance BAC laws.  Ongoing
research is assessing the utility of communication strategies in
preventing alcohol problems among youth.  Applicants are encouraged
to develop and test promising messages, communication technologies,
persuasive styles, and formats to determine the most efficacious and
effective media/communication approaches for varied target groups.
 
Special Populations:  There is a critical need for preventive
intervention research that focuses on understudied populations
including racial/ethnic subpopulations, rural populations, older
Americans, disabled persons, heavy-drinking women in the child
bearing years, and lesbians.  Preintervention studies among these
groups have identified risk and protective factors for alcohol abuse,
populations at excess risk, etiologic processes, and potentially
effective prevention strategies.  However, very few studies have
actually tested the impact of preventive interventions among these
populations.
 
Natural Experiments
 
Naturally occurring preventive interventions are being implemented by
Federal, State, and local governments, educational institutions, and
the private sector to address such problems as drinking and driving,
underage drinking, alcohol-related violence, worksite alcohol abuse,
fetal alcohol syndrome, and sexual risk-taking.  Policy-driven
strategies have proven highly effective in reducing alcohol
consumption and attendant problems.  Examples include increasing the
legal minimum drinking age, lowering legal blood alcohol levels for
drivers, administrative license revocation, and higher taxes on
alcoholic beverages (generally implemented for revenue rather than
prevention purposes).  Naturally occurring multidimensional community
prevention programs have also shown positive results.
 
Natural experiments have both advantages and disadvantages.  In their
favor:  they take place in real-world settings where generalizations
to analogous populations are highly plausible; the interventions do
not have to be subsidized by the research project; where government
bodies initiate the interventions study results are likely to be
policy relevant, indicating whether the strategies are worthy of
diffusion and how they could be improved; and established methods
(such as time series analysis) exist to assess the impact of natural
interventions.  On the negative side:  naturally occurring
interventions rarely permit efficacy studies where strategies being
evaluated are implemented under optimal conditions.  Nor is it
generally possible to conduct randomized controlled trials.
Effectiveness studies based on quasi-experimental designs are usually
the only option.  Time pressures may also negate or limit collection
of pristine baseline data before the intervention is implemented;
acceptance of the intervention and the quality of its implementation
may vary across sites; and identification of appropriate control or
comparison groups can be difficult, particularly for universal
interventions.
 
In selecting natural interventions for possible study, applicants
should consider:  the state of the science on that issue, the
generalizability of research findings, whether a methodologically
sound study can be launched, potential cooperation with the
initiating body (including possible co-funding), types of pre and
post outcome data available or collectable over the proposed time
period, relevant target groups, and the appropriateness of subgroup
analyses (e.g., by gender, ethnicity, and age).  Researchers are also
encouraged to collect prospective and retrospective process data
(qualitative and quantitative) to shed light on causal linkages
between interventions and outcomes.  Current naturally occurring
interventions of interest for research include: strategies to reduce
drunk driving such as per se laws, interlock devices, vehicle
impoundment, combinations of jail and other sentences, victim impact
panels, and special licensing procedures for youth; controls on youth
access to alcohol such as keg registration, increased law
enforcement, and constraints on false identification; server training
programs; college and school-based strategies that implement
legislative and administrative policies; constraints on alcohol
availability (e.g., at sports events); dram shop liability laws;
constraints on alcohol advertising and promotions; health promotion
and moderate drinking messages by advocacy groups and the alcohol
industry; zoning controls on location and density of alcohol outlets;
and other community-initiated prevention programs.  Natural
interventions that have implications for alcohol-problem prevalence
are important to study even if prevention is not a stated goal (e.g.,
alcohol taxes or privatization of outlets).
 
The NIAAA recognizes that Government and private initiatives to
prevent alcohol problems are continually being implemented.  Where
grant review and funding schedules would seriously delay the proposed
research, applicants should discuss these timing problems with the
listed program administrator.
 
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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
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 reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910 Bethesda, MD 20892-7910,
telephone: 301-435-0714, email girg@drgpo.drg.nih.gov. The title and
number of the program announcement must be typed in section 2 on the
face page of the application.
 
Applications for the FIRST award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application. FIRST award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
The completed original application and five legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817-7710 (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer 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 the applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate
national advisory council.  Small Grants do not receive a second
level review by a national advisory council.
 
Review Criteria
 
Criteria to be used in the scientific and technical merit review of
research grant (R01) applications will include the following:
 
1.  The scientific, technical, health or medical significance, and
originality of the proposed research.
 
2.  The appropriateness and adequacy of the research design and
methodology proposed to carry out the research.
 
3.  The adequacy of the qualifications (including level of education
and training) and relevant research experience of the principal
investigator and key research personnel.
 
4.  The availability of adequate facilities, general environment for
the conduct of the proposed research, other resources, and
collaborative arrangements necessary for the research and the
feasibility of implementing the project (including recruitment of
subjects, implementation of the intervention or innovation,
cooperation of relevant organizations, and/or availability and
quality of necessary data).
 
5.  The appropriateness of budget estimates and duration in relation
to the proposed research.
 
6.  Adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will
also be evaluated.
 
The initial review group will also examine the provisions for the
protection of human subjects and the safety of the research
environment.
 
The review criteria for FIRST Awards (R29) are contained in the FIRST
program announcement (revised February 1994). The review criteria for
Small Grants (R03) are contained in the Small Grants program
announcement for NIAAA PA-91-08 dated October, 1990.
 
AWARD CRITERIA
 
Applications recommended for approval will be considered for funding
on the basis of the overall scientific and technical merit of the
application as determined by peer review, program needs and balance,
and the availability of funds.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.  Potential applicants
may obtain copies of specific specific announcements from the
National Clearinghouse for Alcohol and Drug Information, P.O. Box
2345, Rockville, MD 20852, telephone: 301-468-2600 or 1-800-729-6686.
Further information on grant mechanisms and areas of research
interest may be obtained from the program staff listed under
INQUIRIES.
 
Direct inquiries regarding potential research to:
 
Capt. Patricia Mail
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8744 or 443-1677
FAX:  (301) 443-8774
Email:  pmail@willco.niaaa.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Linda Hilley
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0915
FAX:  (301) 443-3891
Email:  lhilley@willco.niaaa.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.273.  Awards are made under the authorization of
the Public Health Service Act, Sections 301 and 464H, and
administered under the PHS policies and Federal Regulations at Title
42 CFR Part 52 and 45 CFR Part 74.  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 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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