COMPREHENSIVE PREVENTION RESEARCH IN DRUG ABUSE

NIH GUIDE, Volume 23, Number 15, April 15, 1994



PA NUMBER:  PA-94-056



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Disease Prevention+ 



National Institute on Drug Abuse



PURPOSE



The purpose of this program announcement is to encourage rigorous

scientific study of the efficacy and effectiveness of multiple

component substance abuse prevention technologies implemented across

several systems including schools, families, peers, and the social

environment (workplace and community) to determine their efficacy and

effectiveness in preventing the onset of drug use and progression to

abuse.  Research focused on the prevention of drug use and the

prevention of drug abuse is encouraged.  Studies should involve the

use of randomized controlled clinical trials or well-controlled

quasi-experimental research designs.  A secondary goal of the

proposed research is the development of psychometrically-sound

measures, instruments and data collection procedures to assess the

process, outcome, and impact of comprehensive prevention strategies.

Special attention should be given to culturally-diverse populations

and to sub-populations at high-risk of drug use onset and

progression.  Research should focus on a broad spectrum of drug

behaviors, such as the use of tobacco products, marijuana,

cocaine/crack, IV drug use, prescription/over-the-counter

medications, and polydrug use/abuse.  Research is encouraged that

focuses on rural and inner-city populations.  Finally, health

services research that assesses the effectiveness of comprehensive

drug preventive care service systems in real world settings is also

requested under this program announcement.



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, Comprehensive Prevention Research in Drug Abuse, is

related to the priority area of alcohol and other drug abuse.

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 foreign and domestic, for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State or local

governments, and eligible agencies of the Federal government.

Applicants from minority individuals and women are encouraged.

Foreign institutions are not eligible for First Independent Research

Support and Transition (FIRST) (R29) Awards.



MECHANISM OF SUPPORT



Support mechanisms include research project grants (R01), small

grants (R03), FIRST awards (R29), program projects (P01), and

Investigator-initiated Interactive Research Project (IRPG) grants

(NIH PA number PA-93-078).  Because the nature and scope of the

research proposed in response to this program announcement may vary,

it is anticipated that the size of an award will also vary.



RESEARCH OBJECTIVES



Background



Epidemiologic research over the last fifteen years indicates that

significant changes in the use of marijuana and cocaine are related

to shifts in the perception of the harmful consequences of drug use

and abuse and personal and social disapproval of the use of illicit

substances.  Controlled intervention research indicates that

comprehensive drug prevention programs can promote the formulation of

anti-drug social norms and thereby prevent the incidence and reduce

the prevalence of the use of cigarettes, alcohol, marijuana, and

cocaine for adolescents exposed to comprehensive prevention programs

in comparison to those youth not receiving these interventions.



Such programs include systematic implementation of multiple

components such as effective use of the media; drug education and

intervention in the schools and workplace; parent education

especially during prenatal, infancy, toddler stage, and early

adolescence; formation of self-help groups; development of community

coalitions to combat drug abuse and drug distribution; and, enactment

and enforcement of salient anti-drug policies within schools, the

workplace, and communities.



The specific objectives of this research program are to determine the

efficacy and effectiveness of comprehensive drug prevention programs

in two general areas:  (1) to measure the short- and long-term

effects of comprehensive drug prevention, and (2) to assess the

generalizability of these research findings to high-risk populations.



Areas of special interest to this program announcement include, but

are not limited to:



Strengthening the Development of Positive Self-Regulated Health

Behaviors



Research is needed to apply our knowledge of relevant determinants of

drug use to the design and testing of interventions that strengthen

the development of positive self-regulated health behaviors.

Etiologic research indicates that drug use and abuse involves a

number of risk factors relevant to the individual, family, peer

group, and social environment and represents only one of a

constellation of interrelated problem behaviors to include:

delinquency, academic failure and dropping out of school, juvenile

depression, running away from home, unwanted pregnancies, suicidal

behavior, sexually transmitted diseases to include HIV infection, and

drug/alcohol related traffic accidents.  Current prevention

intervention research suggests that a comprehensive approach to drug

abuse prevention offers the best chance of positively effecting this

complex problem.  The premise of comprehensive drug prevention is

that program activities should focus on the individual and his or her

interactions with the social environment.



Relevant to the individual, research indicates that a promising

approach to prevention would be one that promoted self-regulated

health behavior. Research is needed to test the effects of preventive

strategies for developing and maintaining:  (1) behavior skills, such

as self-monitoring, goal setting, self-incentives; (2) cognitive

structures, such as self-efficacy and intrinsic motivation; (3)

perceptions of the harmful consequences of drug use/abuse; (4)

awareness of personal and social disapproval of drug use/abuse; and

(5) affective/emotive impulse controls.  Research is needed to assess

how planned interventions focused on these outcomes can strengthen

self-regulated health behavior changes and potentially reduce drug

use/abuse.  However, research indicates that focusing only upon the

individual is insufficient given the vital role played by family,

neighbors, peers, friends, teachers, and others in the social

environment to encourage and reinforce positive health behavior

changes, specifically in regard to the onset, use, and abuse of

cigarettes, alcohol, marijuana, crack/cocaine and other drugs.

Research is needed to assess how social environments can be

structured and strengthened to promote positive self-regulated health

behavior change.



Multiple Component and Comprehensive Prevention Interventions



Research is needed to assess multiple component and comprehensive

strategies that simultaneously utilize the schools, media, family,

peers, social networks, and health policies to both shape and

reinforce the process of self-regulated health behavior change.

Intervention research indicates that a comprehensive approach to drug

abuse prevention that includes multiple program components can

prevent the use of cigarettes, alcohol, marijuana, and cocaine by

youth exposed to the program in comparison to controls.  Research is

needed to test a variety of multiple component prevention strategies.

For example, the combination of drug prevention media and

school/home-based prevention education premised upon social learning

theory may equip youth with generalizable assertiveness skills needed

to resist peer pressure to use drugs.  Research on the use of mass

media combined with school-based prevention education programs has

been encouraging and indicates that these two components are

essential elements of comprehensive drug prevention programming.

Media can increase public awareness of drug abuse problems, promote

organizational involvement in preventing substance abuse, create

public agendas for community action, strengthen drug-free social

norms, stimulate interpersonal discussions relevant to prevention of

drug problems, and reinforce changes in relevant health behaviors of

individuals residing within the community.  School and home-based

social skills training can provide individuals with the specific

behavioral competency to resist and resolve the inter- and

intra-personal pressures to use drugs and alcohol.  Research suggests

that parent education and life skills training can increase family

communication, enhance the use of positive family management

techniques, and promote social bonding within the family.  Research

is needed to assess the efficacy of comprehensive drug prevention

that includes parent education.  In addition, research is needed to

assess comprehensive drug prevention that includes components focused

upon re-structuring the social influences of the peer group,

increasing the social bonding of youth to school, home, workplace,

church or neighborhood youth group, and exposure to positive role

models provided by caring adult neighborhood volunteers, such as

mentoring.  Research is needed for a variety of prevention strategies

to include:  family preservation models, student assistance programs,

modification of school environments, and in-home interventions.



Community Organization, Empowerment, and Change



Research indicates that to be effective, comprehensive drug

prevention needs to extend beyond the individual and social networks

represented by interactions with family, peers, and significant

others in the neighborhood, and include salient changes in community

values, norms, sanctions, and actions relevant to preventing drug

use/abuse and neighborhood drug distribution activities.  Research is

needed to design and test drug prevention strategies that involve

community organizations and institutions that establish an

environment in which durable, positive self-regulated health behavior

change can be developed and maintained.  Community involvement and

commitment to substance abuse prevention has been traditionally a

desired goal of public health programs.  However, much is yet to be

learned concerning the validity of prevention theories prescriptive

of community organization and empowerment and the efficacy of

community change interventions based upon these theories.  Research

is needed to develop and test models of community/environmental

change that capitalize upon existing community leadership and

organizations to deliver effective drug education messages, encourage

environmental change, promote drug-free norms, and establish

community coalitions to take effective preventive/deterrent actions

particularly within high risk neighborhoods.  Research is needed to

develop and test the most effective techniques for community change

that may involve community advisory boards, task forces, parent

groups, professional associations, individual community leaders and

relevant grass roots entities.  Innovative techniques need to be

created and assessed to expand and intensify participation in drug

prevention by a variety of community groups representing

ethnic-minority points of view.  Research is needed to assess the

efficacy of grass-roots community coalitions that have been formed to

rid their neighborhoods of open-air drug markets and crack houses.

Prevention research is needed to assess the short-term and long-term

effects of community-based drug abuse deterrence on both drug

use/abuse and the drug distribution marketplace and the violence that

relates to the presence of drugs in communities.



Research is needed to assess the efficacy of drug-related policies

and legislation to establish drug-free school and community zones and

a drug-free workplace.  Research indicates that effective enforcement

of drug-free policies and legislation can reduce consumption of drugs

to include the use of tobacco products in schools, communities, and

the workplace and drug use/abuse in the military.  Research is needed

to determine how drug-free policies and legislation can enhance the

effects of more traditional comprehensive drug prevention activities

involving schools and families.



Health Services Research



The intent of health services prevention research is to assess the

effectiveness and cost effectiveness of preventive interventions in

reducing drug-related problems, such as adverse medical,

psychological, or social consequences of drug use.  In addition to

intervention studies in health care settings, prevention services

research may occur in a variety of other settings (e.g., worksites,

schools, and local communities) and may focus on financing,

organization, management, enforcement, and utilization of prevention

services as well as their effectiveness.



Research is needed to improve the quality of prevention services, to

expand access to prevention services to all populations, particularly

minorities, and to lower costs of health care by reducing the extent

of drug use and its adverse health and social consequences.



Illustrative drug abuse prevention services research areas include:



o  Qualitative and quantitative assessment of program service

delivery at the community, state, regional, or national level;



o  Outreach research to assess strategies to expand prevention

services to under-served populations and geographic areas, such as

rural communities and inner cities; and,



o  Research to integrate drug prevention with other related

behavioral and societal disorders such as violence prevention, unwed

pregnancy, school drop-outs, and domestic abuse.



Prevention Interventions In Rural Communities



Research suggests that drug abuse in rural communities is on the

increase and requires special attention through the design and

testing of prevention programs and policies that best serve the needs

of rural America.  Prevention intervention research focused upon

rural communities is encouraged by this program announcement



STUDY POPULATIONS



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 new

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 9, 1994 (FR 59 11146-11151), and reprinted

in the NIH GUIDE FOR GRANTS AND CONTRACTS of 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.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91) and will be accepted at the standard application

deadlines indicated in the application kit.  Receipt dates for

applications for AIDS-related research are found in the PHS 398

instructions.  Application kits are available at most institutional

offices of sponsored research and may be obtained from the Office of

Grants Information, Division of Research Grants, National Institutes

of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone

301/710-0267).  The title and number of this program announcement

must be typed in Item 2a on the face page of the application.



FIRST applications must include at least three sealed letters of

reference attached to the face page of the original application.

FIRST 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

Westwood Building, Room 240

Bethesda, MD  20892**



Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research

Resources may wish to identify the GCRC as a resource for conducting

the proposed research.  If so, a letter of agreement from either the

GCRC program director or principal investigator could be included

with the application.



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established PHS

referral guidelines.  Applications will be reviewed for scientific

and technical merit by review groups in accordance with the standard

NIH peer review procedures.  Following scientific-technical review,

the applications will receive a second-level of review by the

appropriate national advisory council.  Small grant (R03)

applications do not receive a second-level of review.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to the NIDA.  The following will be considered

in making funding decisions:  quality of the proposed project as

determined by peer review, program priorities, and availability of

funds.



INQUIRIES



Written and telephone inquiries to clarify any issues or questions

from potential applicants are encouraged.



Direct inquiries regarding programmatic areas to:



William J. Bukoski, Ph.D.

Division of Epidemiology and Prevention Research

National Institute on Drug Abuse

5600 Fishers Lane

Parklawn Building, Suite 9A53

Rockville, MD  20857

Telephone:  (301) 443-1514



Direct inquiries regarding fiscal or grant management issues to:



Gary Fleming, J.D., M.A.

Grants Management Branch

National Institute on Drug Abuse

Parklawn Building, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.279.  Awards are made under authorization of Public

Health Service Act, Sections 301 (42 USC 241) and administered under

PHS grants policies and Federal Regulations at Title 42 CFR Part 52,

"Grants for Research Projects," Title 45 CFR parts 74 & 92,

"Administration of Grants," and 45 CFR Part 46, "Protection of Human

Subjects." Title 42 CFR Part 2 "Confidentiality of Alcohol and Drug

Abuse Patient Records" may also be applicable to these awards.  This

program is not subject to intergovernmental review requirements of

Executive Order 12372 or Health Systems Agency review.  Sections of

the Code of Federal Regulations are available in booklet form from

the U.S. Government Printing Office.  Awards must be administered in

accordance with the PHS Grants Policy Statement (rev. 10/90), which

may be available from your office of sponsored research.



The Public Health Service strongly encourages all grant recipients to

provide a smoke-free workplace and promote the non-use of all tobacco

products.  This is consistent with the PHS mission to protect and

advance the physical and mental health of the American people.



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