NIH GUIDE, Volume 21, Number 17, May 8, 1992

PA NUMBER:  PA-92-75

P.T. 34




  Mental Disorders 


  Data Management/Analysis+ 

National Institute on Alcohol Abuse and Alcoholism


Current research indicates that alcohol dependence and problem drinking

are neither unitary phenomena nor unidimensional syndromes.  Instead,

there appear to be different types of alcohol-dependent individuals.

Individual characteristics other than the kind of alcohol problem also

seem to affect treatment outcomes. It is becoming evident that both

treatment outcomes and costs can be positively affected by carefully

matching patients, by their characteristics, with specific treatments.

This announcement seeks research grant applications to investigate the

therapeutic impact of matching patients more specifically to various


This announcement is a revision of "Alcoholism Treatment: Matching

Clients to Treatments" (Revised April 1989).


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, Research on Alcoholism Patient-Treatment Matching, is

related to the priority area of decreasing morbidity and mortality

associated with alcohol abuse and alcoholism.  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).


Applications for alcohol research grants may be made by domestic and

foreign, public and private, non-profit and for-profit organizations

such as universities, colleges, hospitals, laboratories, units of State

and local governments, and eligible agencies of the Federal Government.

However, foreign institutions are not eligible for the First

Independent Research Support and Transition (FIRST) Award.  Women and

minority investigators are encouraged to apply.


Research support may be requested through applications for a research

grant (R01), small grant (R03), exploratory/developmental grant (R21)

for Alcoholism Treatment Assessment Research, and FIRST Award (R29).

Special announcements for exploratory/developmental grants (R21), the

FIRST Award program (R29), and the small grant program (R03) are

available from the National Clearinghouse for Alcohol and Drug

Information as described under APPLICATION PROCEDURES.

Terms and Conditions of Support

Grant funds may be used for expenses clearly related and necessary to

conduct research projects including direct costs that can be

specifically identified with the project and allowable indirect costs.

Funds may not be used to establish, add a component to, or operate a

treatment, rehabilitation, or prevention service program.  Support for

research-related treatment, rehabilitation, or prevention services and

programs may be requested only for those particular costs and for that

period of time required by the research.  These costs must be justified

in terms of research objectives, methods, and designs that promise to

yield important generalizable knowledge and/or to make a significant

contribution to theoretical concepts.

Grants will be administered in accordance with the PHS Grants Policy

Statement (rev. October 1990), which is usually available from the

office of sponsored research.


No specific funds are being allocated by the National Institute on

Alcohol Abuse and Alcoholism (NIAAA) for this program.  Applications

received in response to this announcement will Compete with others

submitted to the NIAAA for funding.  The amount of funding available

will depend on appropriated funds, quality of research proposals, and

program priorities at the time of the award. In FY 1991, the NIAAA

awarded two grants relating to this program area, including new and

continuation grants, for $428,000.


This announcement solicits research grant applications that propose to

study differences among alcoholism treatment regimens in terms of

efficacy and cost effectiveness for different types of patients.

Specifically, this announcement seeks research projects that: (1) study

the effects of the careful matching of patient variables with treatment

and setting variables, (2) develop prediction techniques to identify

treatments most suitable for patients at various points in the

development of their alcohol dependency or recovery, and/or (3) assess

the relative cost effectiveness of different types of treatment and

settings for different client types.

Although research on individualizing alcoholism treatment based on

patient characteristics is rather new in nature, treatment matching a

appears promising as a means of improving treatment outcomes. Well-

conceived and rigorously designed research is needed to identify

specific therapeutic elements that may contribute to favorable outcomes

for particular subgroups.

Patient factors of interest include, but are not limited to: type of

alcoholism degree of alcohol dependency, family history of alcoholism,

other drug use, psychiatric comorbidities (e.g., depression, panic

attacks, antisocial personality), age (adolescent, adult, aged),

gender, previous treatment history, neurophysiological status/severity,

personality type, general adjustment status, ethnicity, motivation for

treatment, patient preference regarding type of intervention, and

drinking pattern.  Potential treatment variables for patient-treatment

matching include:  treatment modality, program structure, therapist

characteristics (such as perceived empathy, competence, or conceptual

level), and treatment setting, among others.

The use of well-established and validated instruments or techniques for

assessing patient characteristics and treatment outcomes is

recommended.  In keeping with this, preference will also be given to

applications that include both biochemical and self-report measures of

outcome.  Even when cost or cost-effectiveness factors are not a direct

focus of the study, applicants are urged to collect cost data for the

studies, if applicable, and to include an analysis of the comparative

costs of the treatments studied in the final report, if relevant.

Also, since an important as pct of treatment-effectiveness research is

its generalizability to applied treatment programs, applicants are

urged to report the percentage of patients who refuse to participate in

the study or in a particular intervention.  Studies may include

patients at more than one facility in order to determine the

generalizability of matching strategies.  Researchers having access to

data sets dealing with the general effectiveness of a treatment

intervention variable may also propose research projects that involve

secondary data analyses to address the question:  What types of

patients did particularly well with this intervention and which did

poorly?  When sample sizes permit, patient and treatment interactions

to be studied also might include patient-treatment matches that

consider two or more patient characteristics or treatment factors

simultaneously (for example, patient emotional stability and locus of

control matched to degree of structure in treatment).

While a single study may not be sufficient to collect information from

all types of persons seeking alcoholism treatment, applicants may wish

to select certain demographic groups (e.g., women, minorities, military

personnel, elderly, adolescents) and study them intensively for

consideration.  Justification for selection of certain groups is

necessary, as specified in the following section on "Special

Instructions for Inclusion of Women and Minorities as Subjects in


The NIAAA specifically encourages applications that evaluate patient

and treatment factors that have already been shown to have some effect

on outcome in the treatment of alcoholism, drug dependency, and other

behavioral dysfunctions.  The variables selected for study should be

ones for which a strong clinical rationale or empirical argument can be

made regarding their likely contribution to effective patient treatment

matching. Studies investigating the appropriateness of

pharmacotherapeutic techniques for particular patient types are also of

special interest.  Studies of matching and treatment techniques for

severe chronic alcoholics and other difficult-to-treat categories of

alcoholics and alcohol abusers are of special concern as well.




Applications for grants and cooperative agreements and proposals for

contracts that involve human subjects are required to include

minorities and both genders in study populations so that research

findings can be of benefit to all persons at risk of the disease,

disorder, or condition under study; special emphasis should be placed

on the need for inclusion of minorities and women in studies of

diseases, disorders, and conditions which disproportionately affect

them.  This policy applies to all research involving human subjects and

human materials, and applies to males and females of all ages. If one

gender and/or minorities are excluded or are inadequately represented

in this research, particularly in proposed population-based studies, y

clear compelling rationale for exclusion or inadequate representation

should be provided. The composition of the proposed study population

must be described in terms of gender and racial/ethnic group, together

with a rationale for its choice.  In addition, gender and racial/ethnic

issues should be addressed in developing a research design and sample

size appropriate for the scientific objectives of the study.

Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, NIH

and ADAMHA recognize that it may not be feasible or appropriate in all

research projects to include representation of the full array of United

States racial/ethnic minority populations (i.e., American Indians or

Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics).

Investigators must provide the rationale for studies on single minority

population groups.

Applications for support of research involving human subjects must

employ a study design with minority and/or gender representation (by

age distribution, risk factors, incidence/prevalence, etc.) appropriate

to the scientific objectives of the research.  It is not an automatic

requirement for the study design to provide statistical power to answer

the questions posed for men and women and racial/ethnic groups

separately; however, whenever there are scientific reasons to

anticipate differences between men and women, and racial/ethnic groups,

with regard to the hypothesis under investigation, applicants should

include an evaluation of these gender and minority group differences in

the proposed study.  If adequate inclusion of one gender and/or

minorities is impossible or inappropriate with respect to the purpose

of the research, because of the health of the subjects, or other

reasons, or if in the only study population available, there is a

disproportionate representation of one gender or minority/majority

group, the rationale for the study population must be well explained

and justified.

The NIH/ADAMHA funding components will not make awards of grants,

cooperative agreements, or contracts that do not comply with this

policy.  For research awards which are covered by this policy, awardees

will report annually on enrollment of women and men, and on the race

and ethnicity of subjects.

Protection of Human Subjects

The Department of Health and Human Services (DHHS) has regulations for

the protection of human subjects and has developed additional

regulations for the protection of children.  A copy of these

regulations (45 CFR 46, Protection of Human Subjects) and those

pertaining specifically to children are available from the Office for

Protection from Research Risks, National Institutes of Health, Building

31, Room 5B59, Bethesda, MD 20892, telephone (301) 496-7041.  Specific

questions concerning protection of human subjects in research may be

directed to the staff member listed under INQUIRIES.

An applicant organization proposing to conduct nonexempt research

involving human subjects must file an "Assurance of Compliance" with

the Office for Protection from Research Risks.  As part of this

Assurance which commits the applicant organization to comply with the

DHHS regulations, the applicant organization must appoint an

institutional review board, which is required to review and approve all

nonexempt research activities involving human subjects.


Applicants are to use the grant application form PHS 398 (rev. 9/91).

The number and title of this announcement, "Research on Alcoholism

Patient-Treatment Matching - PA-92-75," must be typed in item 2a on the

face page of the PHS 398 application form.

Application kits containing the necessary forms and instructions (PHS

398) 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


National Clearinghouse for Alcohol and Drug Information

P.O. Box 2345

Rockville, MD  20852

Telephone:  (301) 468-2600 or 1-800-729-6686

The signed original and five permanent, legible copies of the completed

application must be sent to:

Division of Research Grants National Institutes of Health Westwood

Building, Room 240 Bethesda, MD 20892


The Division of Research Grants, NIH, serves as a central point for

receipt of applications for most discretionary PHS grant programs.

Applications received under this announcement will be assigned to an

Initial Review Group (IRG) in accordance with established PHS Referral

Guidelines.  The IRGs consisting primarily of non-Federal scientific

and technical experts will review the 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 an appropriate National Advisory

Council.  Only applications recommended by a Council may be considered

for funding.

Application Receipt and Review Schedule

Applications will be accepted and reviewed according to the following


Receipt Dates      Initial      Advisory         Earliest

New/Renewal        Review     Council Review     Start Date

Jun l/Jul l*       Oct/Nov       Jan/Feb         Apr 1

Oct l/Nov l*       Feb/Mar       May/Jun         Jul 1

Feb l/Mar l*       May/Jun       Sep/Oct         Dec 1

* Competing continuation, supplemental, and revised applications are to

be submitted on these dates.

Consequences of Late Submission

Applications received after the above receipt dates are subject to

assignment to the next review cycle or may

be returned to the investigator without review if requested by the


Review Criteria

Criteria for scientific/technical merit review of applications for

research grants (R01) will include the following:

o The overall scientific and technical merit and significance of the

proposed research.

o The appropriateness and adequacy of the experimental design including

the adequacy of the methodology proposed for collection and analysis of


o The adequacy of the qualifications (including level of education and

training) and relevant research experience of the Principal

Investigator and key research personnel.

o The availability of adequate facilities, general environment for the

conduct of proposed research, other resources, and any collaborative

arrangements necessary for the research.

o The appropriateness of budget estimates for the proposed research


o Where applicable, the adequacy of procedures to protect or minimize

possible adverse effects on humans, animals, or the environment.

o Conformance of the application to the ADAMHA/NIH policy on inclusion

of women and minorities in study populations.

The review criteria for small grants (R03), exploratory/developmental

grants (R21), and FIRST Awards (R29) are contained in the specialized

announcements that are available from the National Clearinghouse for

Alcohol and Drug Information as described under APPLICATION PROCEDURES.


Applications recommended by a National Advisory Council will be

considered for funding on the basis of overall scientific and technical

merit of the research as determined by peer review, program needs and

balance, and availability of funds.


Potential applicants are encouraged to seek preapplication consultation

and may contact the individual listed below for consultation in

preparing an application under this announcement. Direct inquires to:

Margaret Mattson, Ph.D.

Treatment Research Branch

Division of Clinical and Prevention Research

National Institute on Alcohol Abuse and Alcoholism

5600 Fishers Lane, Room 14C-20

Rockville, MD  20857

Telephone:  (301) 443-0796

Inquiries relating to fiscal matters may be directed to:

Elsie Fleming

Grants Management Branch

Office of Planning and Resource Management

National Institute on Alcohol Abuse and Alcoholism

5600 Fishers Lane, Room 16-86

Rockville, MD  20857

Telephone:  (301) 443-4703


This program is described in the Catalog of Federal Domestic

Assistance, No. 93.273.  Awards are made under the authority of

Sections 301 and 510 of the Public Health Service Act, as amended (42

USC 241 and 290bb).  Federal regulations at 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.  This program is not subject to the intergovernmental

review requirements of Executive Order 12372 or Health Systems Agency



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