PREVENTION SERVICES RESEARCH REPLICATING A SCHOOL-BASED PROGRAM

Release Date:  January 20, 1999

RFA:  DA-99-006

P.T.

National Institute on Drug Abuse

Letter of Intent Receipt Date:  March 13, 1999
Application Receipt Date:  April 13, 1999

PURPOSE

This Request for Applications (RFA) solicits applications to examine in actual
practice settings the effectiveness of a school-based prevention intervention
previously shown to be efficacious through NIDA-funded research.  An Office of
Juvenile Justice and Delinquency Prevention (OJJDP) program provides the
opportunity for the National Institute on Drug Abuse (NIDA) to collaborate in
funding a prevention services study.  Specifically, the OJJDP is sponsoring
multiple replications of the Life Skills Training program in community settings,
including the collection of process data.  The NIDA RFA will sponsor the outcome
research portion for the OJJDP project and include linking the process data to
the outcome data.

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 RFA, Prevention Services Research
Replicating a School-Based Program, is related to the priority areas of alcohol
and other drugs.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No. 017-001-
00473-1) through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, research institutions, and units of state and of local governments,
and eligible agencies of the Federal government.  Applications from minority
individuals, women, and persons with disabilities are encouraged.

MECHANISM OF SUPPORT

The support mechanism for the RFA is a research project grant (R01). 
Consultation with NIDA program staff prior to application is strongly encouraged.

The total project period for an application submitted in response to this RFA may
not exceed five years.  The anticipated award date is September 30, 1999.  This
RFA is a one-time solicitation.  Future unsolicited applications will compete
with all investigator-initiated applications and be reviewed according to
standard peer review procedures.

FUNDS AVAILABLE

The NIDA has set aside up to $1 million total costs for the first year of funding
for this project.  One award will be made on the basis of high scientific merit. 
The project period is expected to be 5 years.  Budget requests should be
carefully justified and commensurate to the complexity of the project.  Although
this program is provided for in the financial plans of NIDA, awards pursuant to
this RFA are contingent upon the availability of funds for this purpose.

It is expected that one application will be selected and supported at an annual
total cost of up to $1 million dollars per year for a period of 5 years.

RESEARCH OBJECTIVES

Prevention Services Research examines issues related to the provision and
effectiveness of prevention interventions in naturally occurring contexts.  It
is the outgrowth of efficacy and effectiveness research conducted in controlled
research environments.  Specific issues of interest include implementation
practices (e.g., training, dosage, and fidelity), barriers to implementation
(e.g., accessibility of program to audience, program cost), and implementation
costs (e.g., monetary, human resource), especially in relation to the
effectiveness of an intervention presented with relatively little scientific
control.  Over the past 20 years, a number of theory-based drug abuse prevention
intervention programs have been developed and tested under controlled conditions
and have been shown to reduce drug initiation, use, and abuse among target
populations.  Many have been replicated under controlled conditions and have
maintained their effectiveness.  However, few of these programs are in widespread
use at the local level.  Communities are anxious for effective programming but
perceive barriers to implementing research-based models.

One research-based program that has been shown to be effective with a wide
variety of audiences is the Life Skills Training (LST) Program developed by
Gilbert Botvin, Ph.D.  The LST Program is based on Social Learning Theory, which
posits that people learn behaviors through processes of modeling and
reinforcement.  The LST is a universal intervention program that targets the
prevention of drug use initiation and progression among adolescents through
reducing risk and enhancing protective factors.  This 3 year school-based
intervention is initiated in grade 6 or 7 and consists of 15 sessions in year 1,
10 booster sessions in year 2, and 5 booster sessions in year 3.  Program content
focuses on: self-management skills, social skills, and drug use resistance
skills.  Six-year follow-up results of an implementation of this intervention
with a White middle-class population demonstrated significantly lower rates of
drug and polydrug use among experimental group students compared with control
group students. Controlled replications with other ethnic groups have also
demonstrated effectiveness, especially when the program has been minimally
tailored to meet cultural needs.  Dosage was found to influence outcome, with
those receiving most of the intervention showing better outcomes.

In 1996, the Center for the Study and Prevention of Violence (CSPV) at the
University of Colorado, in conjunction with a variety of state and federal
agencies set out to identify violence and drug abuse prevention programs that met
the highest scientific standards of program effectiveness.  Examination of
approximately 400 programs resulted in the identification of 10 such programs;
among these is the LST.  The OJJDP is funding the next phase of this work by
supporting schools and/or agencies in the implementation of these programs
through the provision of training, materials, and technical assistance.  In a
special grants program called the Training and Technical Assistance for a Drug
Prevention Program (available at URL address 
http://www.ncjrs.org/pdffiles/94646.pdf), the OJJDP, in collaboration with CSPV,
will provide this support to approximately 60 communities who wish to implement
the LST Program.  In addition, the CSPV will track and collect implementation
process data.

This NIDA RFA will support the outcome evaluation portion for the OJJDP program
of work.  To facilitate the outcome evaluation component, school and/or local
educational agencies funded by the OJJDP portion of the project (hereafter
referred to as implementation units) must have agreed to and arranged for the
following conditions prior to their application to OJJDP:

(1) implementation units must have documented the cooperation and assurance of
the school or local educational agency administration to (a) provide matched
sites for random assignment to either intervention or control conditions (for the
NIDA study, it is anticipated that up to 30 implementation units will be randomly
selected from among the approximately 60 available implementation units); (b)
assist in obtaining informed consent from parents for their children's
participation in the project; and (c) cooperate with the administration of
pretests, posttests, and annual follow-up school surveys through the students'
high school years to assess the impact of the implementation over time;

(2) implementation units must have agreed to collaborate with the NIDA-funded
prevention researcher(s) in designing and administering surveys to assess risk
and protective factors, potential mediators, and proximal and distal outcomes of
program effectiveness--such as school environment (school policies, school
behavioral norms), drug use behaviors, perceptions of risk, and changes over time
in the development of skills and/or other essential components of the
intervention; and

(3) implementation units must have agreed to allow the NIDA-funded researcher(s)
access to all process evaluation data including, for example, those data that
address the success of the training, monitor the fidelity of the implementation,
track participation rates, and identify barriers to implementation.

Applicant institutions for the NIDA RFA should recognize that the only stable
elements across implementation units are the training, technical assistance,
provided materials, and process evaluation.  Thus, development of the theoretical
model--the measurement, design, and analysis plans--and collaborative
relationships with the agencies involved is of critical importance. Consequently,
NIDA RFA applicants should address the following issues.

Theoretical model.  Applicants should address the conceptualization of a systemic
model of processes through which the LST intervention is posited to bring about
individual and school change.  For example, applicants could provide a schema for
examining antecedents, mediators, and proximal and distal outcomes addressed by
the LST Program, incorporating process variables that may influence outcome.
Community and school environmental factors associated with adolescent substance
use could be incorporated into the model (e.g., local policies, ordinances and
laws regarding youth substance use, law enforcement activities, school policies
and enforcement, school curriculum).  The schema might consider both the expected
normative trajectories of development and changes expected to take place over
time as the result of the program.  The ultimate goals of developing such a
theoretical schema would be to provide a rationale for defining constructs to be
tested and for developing an analysis plan.

Measurement plan.  Applicants should identify and/or develop measures suitable
to the theoretical model on which the LST Program is based.  The measurement plan
might include measures of the community environment, the school environment,
individual qualities that relate to both susceptibility to drug use and the
potential for success in the LST Program, program content including the skills
taught to assess changes in competence over time, and proximal and distal outcome
measures at both the individual and community levels.  Archival data and subject
matter experts and other key informants may be the most appropriate sources for
some community and school environment data.

Data collection.  Applicants should address issues related to a data collection
strategy including both experimental and non-treatment control groups.  Projects
of this magnitude usually include data collection at pre-test, after each year
of implementation, and follow students for a period of time after the program
ends. The focus of such a strategy is usually on the determination of differences
in distal outcomes between the experimental and control groups.

Data management.  Applicants should address state-of-the-art data management
issues and techniques, such as quality control, missing data, differential
attrition, and contamination effects.

Data analysis.  Applicants should address an analysis plan built on the
theoretical model.  The analysis plan might include a view of individuals nested
within classrooms, nested within schools, and take into consideration community
and other environmental influences over time. Multiple levels of data, including
process data, may need to be incorporated into the analysis plan to gain an
understanding of how and why the LST Program may differentially affect students
from various racial/ethnic/cultural/regional backgrounds.

Collaborative relationships.  The RFA involves a project with many partners.
Collaborative partners include OJJDP, CSPV, training coordinators, and
implementation units. Applicants should be aware of and recognize the
collaborative nature of the project. For example, as part of the collaboration,
applicants may need to consider the completeness of the available process data
for the NIDA-funded portion of the project and collect or negotiate the
collection of additional data.

In addition, applicant institutions for the NIDA RFA should address a timeline
for data collection and analysis.

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 are 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 were published in the Federal Register on March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts on March 18, 1994,
Volume 23, Number 11.  Investigators may obtain copies from these sources or from
the program staff or contact person listed below.  Program staff may also provide
additional relevant information concerning the policy.

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://grants.nih.gov/grants/guide/notice-files/not98-024.html

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS

The National Advisory Council on Drug Abuse recognizes the importance of research
involving the administration of drugs to human subjects and has developed
guidelines relevant to such research.  Potential applicants are encouraged to
obtain and review these recommendations before submitting an application that
will administer compounds to human subjects.  The guidelines are available on
NIDA's Home Page at http://www.nida.nih.gov under "Funding" or may be obtained
by calling 301-443-2755.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 13, 1999, a letter of intent
that includes a descriptive title of the overall proposed research; the name,
address, telephone number, and institution of the Principal Investigator; the
names of other key investigators and their respective institutions; and the
number and title of this RFA.  Although a letter of intent is not binding, is not
required, and is not a factor in the peer review of the application, the
information that it contains allows NIDA staff to estimate the potential review
workload and avoid conflict of interest in the review.

The letter of intent is to be sent to:

Director
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98).  These forms are available at most institutional offices of sponsored
research and may also be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC-
7910, Bethesda, MD 20892, telephone 301-435-0714, Email: GrantsInfo@nih.gov.

The RFA label available in the PHS 398 application form must be affixed to the
bottom of the face page of the application.  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.  In addition, to ensure the identification
of the application with this RFA, the YES box must be marked in Item 2 of the
face page of the application form and the title and number of this RFA typed in. 
Applications that are not received as a single package from the Principal
Investigator and that do not conform to the instructions contained in the PHS 398
(rev. 4/98) application kit will be judged non-responsive and will be returned
to the applicant.

The completed original, including the checklist, and three legible copies must
be sent or delivered to:

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

At the time of submission, two additional copies of the application must be sent
to:

Director
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755

Applications must be received by April 13, 1999.  If an application is received
after this date, it will be returned to the applicant without review.  The Center
for Scientific Review (CSR) will not accept any application in response to this
RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The CSR will not accept any
application that is essentially the same as one already reviewed.  This does not
preclude the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing the
previous critique.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed for completeness by the CSR and for
responsiveness by the NIDA staff.  Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration or review. 
Applications that are complete and responsive to this RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIDA in accordance with the review criteria stated below.

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 and assigned a priority score.  A second level review
will be conducted by the National Advisory Council on Drug Abuse.

General Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques 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 by the reviewers 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 a 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:  What will be the effect of this study on the concepts or
methods that drive this field?

More specifically, reviewers will assess issues such as:

Significance of the factors incorporated into the measurement model for detecting
how the LST intervention can prevent or reduce initiation, use, and abuse of
drugs.

Strength and adequacy of plans for disseminating results in a timely manner.

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

More specifically, reviewers will assess such issues as:

Compatibility of the theory presented for the design of a replication evaluation
of Botvin's Life Skills Training (LST) intervention and plans to ensure the
comparability of data gathered in the proposed research with data from previous
studies of LST.

Adequacy of the proposed constructs to test the effectiveness of LST
interventions delivered in naturally occurring school and community contexts, and
suitability of the proposed measures of environmental variables, program
characteristics, and individual attributes.

Quality of plans for establishing effective communication linkages with OJJDP,
CSPV, community implementation units, and NIDA, including plans for collaborative
planning and implementation of the proposed research, tracking of research
participants, and strategies for solving potential research problems
cooperatively.

Ability of the research design to provide a rigorous, effective test of the
intervention and to compare effects across various student subpopulations
(disaggregated by gender, ethnicity, region, etc.).

Strength of plans for overall quality assurance and the management of data
collection and analyses, plans for merging process data collected by CSPV with
outcome data collected in the proposed replication research.

Adequacy of plans to assure appropriate protection of the rights and safety of
subjects and to guarantee the quality, integrity, and confidentiality of
resulting data.

Appropriateness and feasibility of proposed schedule for data collection,
analysis, and dissemination.

3.  Innovation:  Is the approach original and innovative, and does it use novel
methodologies and technologies?

More specifically, does the application reflect:

Innovativeness in explicating the processes underlying the LST intervention.

The use of state-of-the-art theoretical, methodological and statistical
innovations in the development and implementation of the research project.

Consideration of untested or understudied theory-based factors related to the
effectiveness of LST in naturally occurring settings.

Resourcefulness in identifying relevant additional data sources and adequate
justification for use of these sources.

Quality of the plan to incorporate state-of-the-art data collection technologies
and procedures.

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)?

More specifically, reviewers will assess the investigative team with respect to:

Knowledge and experience pertaining to drug prevention research within the
community and school contexts and pertinent to the targeted populations.

Expertise in state-of-the-art data analytic designs, techniques, and strategies.

Adequacy of qualifications, research experience, and time commitment of the
investigators and other key staff, including previous experience with design,
administration, management, and coordination of multi-unit effectiveness studies.

Experience in constructing and administering survey instruments and gathering
process and archival data.

Adequacy of resources and personnel for management of databases, including
previous experience in developing and implementing an internal program for data
quality assurance, security, and confidentiality.

Ability of researchers to develop collaborative working relations with a variety
of research partners.

5.  Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Does the proposed research take
advantage of unique features of the scientific environment and useful
collaborative relationships? Is there evidence of institutional support?

More specifically, does the application demonstrate the:

Adequacy of available facilities and resources to carry out the proposed work.

Strength of the proposed organizational structure to contribute to the proposed
research.

Strength of the organizational structure to foster collaboration among research
partners.

In addition to the above criteria, and in accordance with NIH policy, all
applications will also be reviewed with respect to the following: (1) adequacy
of plans to include both genders, minorities and their subgroups, and children
as appropriate for the scientific goals of the research and (2) reasonableness
of the proposed budget and duration of the project in relation to the proposed
research.

Plans for data archiving and sharing should be directly addressed in grant
applications since it is expected that data gathered under this RFA will be made
available to the scientific community in a timely fashion for subsequent analyses
(after first use).  The quality of the plans for data archiving and sharing (or
the justification for not doing so) will be assessed by the initial review group. 
Funds for data archiving and sharing may be requested in the grant application.

AWARD CRITERIA

The predominant criteria for funding priorities will be the scientific and
technical merit of applications in response to this RFA.  Consideration will be
given to the following factors in the final selection of applications to be
funded: (1) the ability of the applicant to cover all points of the scientific
agenda; (2) the appropriateness of budget estimates; and (3) the availability of
funds.

Schedule

Letter of Intent Receipt Date:  March 13, 1999
Application Receipt Date:       April 13, 1999
Scientific Review Date:         July/August 1999
Council Meeting Date:           September 1999
Earliest Award Date:            September 1999

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Elizabeth B. Robertson, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, MSC 9589
Bethesda, MD  20892-9589
Telephone:  (301) 443-1514
FAX:  (301) 443-2636
Email:  er52h@nih.gov

Direct inquiries regarding peer review issues to:

Teresa E. Levitin, Ph.D.
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
Email:  tl25u@nih.gov

Direct inquiries regarding fiscal matters to :

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
Email:  gf6s@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.279.  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 are administered under PHS grants policies and Federal Regulations
42 CFR 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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