DRUG ABUSE TREATMENT FOR WOMEN OF CHILDBEARING AGE AND THEIR CHILDREN

NIH GUIDE, Volume 22, Number 32, September 3, 1993



PA NUMBER:  PA-93-106



P.T. 34



Keywords:

  Drugs/Drug Abuse 



National Institute on Drug Abuse



PURPOSE



The purpose of this program announcement is to stimulate research to

improve the effectiveness of drug abuse treatment for women of

childbearing age and their offspring.



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, Drug Abuse Treatment for Women of Childbearing Age and

Their Children, is related to the priority area of health

promotion/alcohol and other drugs.  A copy of "Healthy People 2000"

(Full Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No.

017-001-00473-1) may be obtained 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, public and private organizations such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal Government.  Women

and minority investigators are encouraged to apply.



MECHANISM OF SUPPORT



This program announcement will use the National Institutes of Health

(NIH) individual research grant (R01).  Responsibility for the

planning, direction, and execution of the proposed project will be

solely that of the applicant.  Support will be provided for a period of

up to five years (renewable for subsequent periods) subject to

continued availability of funds and progress achieved. In fiscal year

1994, it is anticipated that $5 million will be available from the

National Institute on Drug Abuse (NIDA) to fund approximately eight to

nine grants under this announcement.



Research projects requiring substantial programmatic support, such as

the establishment of new comprehensive services or the addition of a

substantial component to an existing program, are encouraged under this

announcement.  If required in support of research objectives, funds may

be expended on drug abuse treatment costs, rental and operation of

facilities, approved renovation and modification of facilities (subject

to limits and conditions specified in the PHS grants policy), and other

costs normally allowable under existing PHS grants policy.  Funds may

not be used for new construction or to replace existing treatment

funding.



RESEARCH OBJECTIVES



Summary



Research studies are sought to investigate effective and cost-effective

drug abuse treatment for women and their children.  Research is sought

to:  (1) improve outcomes of drug abuse treatment for women of

childbearing age and their young children; (2) improve treatment

recruitment, retention, and compliance; (3) improve interventions for

women with co-existing mental disorders and to reduce family and social

dysfunction; (4) improve the drug abuse treatment environment, delivery

of services, and service linkages in order to facilitate recovery from

drug abuse; and (5) understand and remove barriers to drug abuse

treatment for women, particularly for pregnant women and women with

children.



Background



This announcement builds on a NIDA program of research established with

Requests for Applications 89-03 (Research Demonstration Grants on Drug

Treatment ... For Pregnant Women) and 90-12 (Research Demonstration

Applications on Drug Abuse Treatment for Women of Child-Bearing Age and

their Offspring).  Both new applicants and those investigators

previously funded under the above-cited programs are eligible.



The treatment needs of women often differ from those of men.  Women who

abuse drugs face a variety of barriers to treatment entry, engagement

in treatment, and long-term recovery.  Barriers to entry include a lack

of economic resources, referral networks, women-oriented services, and

conflicting child-related responsibilities.  Engagement in treatment

and consequent long-term recovery are hampered by the primarily male

orientation of traditional models of drug treatment and aftercare; by

women-specific problems such as low self-esteem, low employability, and

a lack of appropriate services to treat social, psychiatric, and

medical disorders.  Women who are addicted are also more likely to

engage in high-risk sexual behavior, such as sex in exchange for crack,

that increases the risk of becoming pregnant as well as the risk of

contracting infectious diseases such as HIV.



Maternal drug abuse may complicate delivery of offspring and compromise

the newborn child's chance of normal mental and physical development.

Research on improved therapeutic programs and supportive services is

needed to address drug abuse treatment and medical treatment needs of

the mother and child before and after delivery.



Research presently underway suggests a number of areas in which further

investigation is needed.  Applications focused on culturally

appropriate treatment strategies and program models for women and

children of special populations (i.e., programs designed to serve

unique needs of specific racial/ethnic minorities), women in high-risk

groups (e.g., engaged in prostitution), or under criminal justice

supervision are of particular interest.  Additional study is needed on

methodological issues such as research design and the measurement of

behavior change.  Research may focus on outreach strategies to improve

entry of women into drug abuse treatment, on removing barriers to

treatment, and on making such treatment more attractive (e.g., by

providing a range of health services, by adding child care to programs

and/or allowing mothers to have their children live with them in

residential treatment).  Studies suggest that women may benefit from

services such as assertiveness training, counseling to build

self-esteem, social skills enhancements, social network interventions,

treatment for depression, and counseling in family planning and birth

control.  Case management approaches to coordinate services and

maintain the integrity of treatment plans can improve treatment

outcomes.  Other useful components include psychoeducational strategies

and relapse prevention.



Program Description



Research is sought to improve the outcomes of treatment for women of

childbearing age, including treatment for mothers and their young

children; improve recruitment, retention, and compliance with

treatment; investigate strategies to deal with comorbidity and

family/social dysfunction; improve the drug abuse treatment program

environment and the delivery of treatment services in order to

facilitate recovery from drug abuse, and to investigate the impact of

barriers to entry and engagement in drug abuse treatment that exist for

women, particularly pregnant women and women with young children.



Applicants are advised to review existing information relevant to the

treatment of drug abusing women and their children, including pregnant

and postpartum women.  The NIDA will support studies to investigate the

short- and long-term effectiveness of comprehensive drug abuse

treatment for women and their young children based in a variety of

settings (e.g., hospitals, outpatient clinics, residential facilities,

home-based care).  Areas of research interest include research to:



o  Improve treatment recruitment, retention, compliance, and outcomes

for women, with and without children, and their children.



o  Evaluate the effectiveness of psychosocial interventions developed

for women, or gender-specific modifications of existing therapeutic

approaches.



o  Investigate the effectiveness and cost-effectiveness of drug abuse

treatment, aftercare, and ancillary services for women, including

pregnant women and women with young children, designed to address

medical, mental health, social, vocational, educational, family, and

related problem areas.



o  Improve linkages and reduce overlap between service providers and to

enhance ancillary service support structures.



o  Investigate the roles of comorbidity, family/social dysfunction,

marital discord, criminal behavior, low employability, homelessness,

and other factors that predict relapse to illicit drug use, and

identification of effective treatment strategies for dealing with

these.



o  Improve treatment program environments for women, including

overcoming barriers to implementation of effective treatment programs

and improving treatment service delivery to help engagement in

treatment and long-term recovery.



o  Reduce the impact of barriers to drug abuse treatment that exist for

women, particularly for pregnant women or women with young children.



The importance of a sound research plan and qualified research staff

cannot be over-emphasized.  It is recommended that investigators use

the most rigorous methodology consistent with the purposes of the

research.  All applications should address issues of project

feasibility and collaborative arrangements, study design, sampling

procedures, implementation of the intervention, instrumentation and

measurement, data collection, quality control, tracking of clients,

followup, and data analysis, as appropriate.



Investigators are encouraged to offer HIV testing and counseling in

accordance with current guidelines to subjects identified during the

course of the research as being at risk for HIV acquisition or

transmission.  In high-risk populations, investigators are encouraged

to assess the effects of new interventions on the acquisition and

transmission of infectious diseases, including HIV.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



Applications for clinical research grants and cooperative agreements

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 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 minorities are excluded

or are inadequately represented in this research, particularly in

proposed population-based studies, a 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, 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

recognizes 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 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 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.



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

as indicated in the application kit.  Applicants who are currently

supported under NIDA research demonstration program (R18) will be

considered competing continuations (type 2) R01s and may submit their

applications for the competing continuation receipt dates of November

1, March 1, or July 1.  The 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 Grant

Information, Division of Research Grants, National Institutes of

Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone

301/710-0267.  The title and number of the announcement must be typed

in Item 2a on the face page of the application.



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

398 form must be delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



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

receipt of applications for most discretionary DHHS 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 in accordance with the standard NIH peer review

procedures.  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 Advisory Council, whose review

may be based on policy considerations as well as scientific merit.

Only applications recommended for further consideration by the Council

may be considered for funding.



AWARD CRITERIA



Applications recommended for further consideration by an appropriate

Advisory Council will be considered for funding on the basis of overall

scientific, clinical and technical merit of the proposal as determined

by peer review, appropriateness of budget estimates, program needs and

balance, policy considerations, adequacy of provisions for the

protection of human subjects, and availability of funds.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Frank Tims, Ph.D. or Jack Blaine, M.D.

Division of Clinical Research

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-4060



Direct inquiries regarding fiscal matters to:



Chief, Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, 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 the Public Health

Service Act, Section 301, and administered under PHS policies and

Federal Regulations at Title 42 CFR 52 "Grants for Research Projects",

Title 45 CFR Part 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 the

intergovernmental review requirements of Executive Order 12372 or

Health Systems Agency review.



.

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