Full Text PA-96-013 DRUG ABUSE PREVENTION THROUGH FAMILY INTERVENTION NIH GUIDE, Volume 25, Number 1, January 26, 1996 PA NUMBER: PA-96-013 P.T. 34 Keywords: Drugs/Drug Abuse Disease Prevention+ Family Health/Planning/Safety National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to test, under controlled conditions, the efficacy and effectiveness of theory-based drug abuse prevention intervention for families at risk for abusing drugs. For the purpose of this PA, the term family can have a broad definition to include: family of origin; family of procreation; biological kin; nonrelated persons who consider themselves part of the family through mutual commitment or a combination of these. The family may live in one household, or members may live in different households. Research has demonstrated that there are a number of precursors to the initiation of substance abuse, many of which relate to risk or protective factors in the family. One of the primary responsibilities of the family is a protective function. The family is seen as a first line of defense in imparting pyschological infrastructures such as self esteem to prevent vulnerability to drug abuse. In many situations, however, the family is not able to assume the function of nurturance and protection and may be considered a risk factor contributing to vulnerability. Therefore, it is important that family prevention interventions reduce family risk factors and foster protective factors to negate the initiation of drug abuse. 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 PA, Drug Abuse Prevention through Family Intervention, is related to the priority area of health promotion/alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (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 foreign and domestic, 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), small grant (R03) and the FIRST (R29) award. Because the type and scope of proposed research responsive to this Program Announcement may vary, it is anticipated that the size and period of the award will also vary. Awards made under the R29, R03 or R21 mechanism may not be renewed, but it is expected that projects supported by these mechanisms will provide sufficient data to apply for support of a research project grant (R01). There are special requirements and criteria for the program project (P01), FIRST (R29), small grant (R03), and exploratory/developmental (R21) grant applications. The FIRST award is intended for investigators at the beginning of their careers who have not been previously designated as a principal investigator on any PHS research project (except R03). The small grant award (R03) is intended for new or established investigators beginning in a new area. The exploratory/ developmental grant (R21) is intended for investigators to apply experience and sound methodology from other scientific areas to drug addiction research. If any applicant intends to apply utilizing any of these mechanisms, he or she should contact the program person listed in INQUIRIES for further information. RESEARCH OBJECTIVES Background The dynamics of social, psychological and familial factors in combination play a predominant role in the initiation and continuation of substance abuse (Botvin, Schinke, Orlandi, 1989). Correlational research has demonstrated that there are a number of precursors to the initiation of substance abuse, many of which relate to the family. Some of these precursors include: relationships with peers who use drugs, psychosocial development (e.g. conduct disorders), low academic performance, parental use of drugs and alcohol, inadequate mother-infant bonding and nuturance, sexual or physical abuse in childhood, economic instability, poor family management, (e.g. ineffective monitoring by the parents), antisocial behavior, high levels of stress and conflict, juvenile delinquency, genetic propensity toward substance abuse; low self-esteem, and high sensation-seeking. Dishion, Patterson, and Reid (1988) found significant correlations between the child's early drug use and composite scores reflecting maladjustment, including antisocial behavior, coercive behavior with family members, self-esteem and depression. Attitudes, beliefs, and personality traits showing a lack of social bond between the individual and society are involved in delinquency and drug abuse. Research findings suggest a link between certain personality traits, specifically antisocial and neurotic traits and the risk for substance abuse; however adverse outcomes also depend on a variety of developmental and environmental factors (Tarter, 1988). Brook and colleagues proposed a family interactional theory for explaining psychosocial aspects of adolescent drug use including developmental perspectives, family influences and vulnerability factors. They found that peer drug use risks were offset by protective factors such as adolescent and parent conventionality, maternal adjustment, and strong parent-child attachment. (Brook, Brook, Gordon, Whiteman, et al. 1990). Research has suggested that when families become involved positively, precursors can be reduced and early signs of problems can be turned around (Bry, 1983). Most prevention intervention studies have been conducted on children from middle school through high school with a few intervening in 4th and 5th grades. The literature, however, is beginning to suggest that children at risk can be identified as early as preschool for prevention interventions. Dishion, Reid and Patterson's (1988) studies show that an effective family intervention should target parent monitoring, peer associates, parents' drug use, social skills and antisocial behavior; and that parent and peer training interventions are viable methods of preventing premature drug use. Most family oriented prevention-interventions involve the parent or family and focus on strengthening the family's role in positive socialization of the child in hopes of preventing future alcohol or drug abuse in a child who is currently not an abuser (DeMarsh and Kumpfer, 1985). Family prevention interventions represent a variety of approaches and techniques including parent-child interactions, communication and affective skill building, child management principles and parenting styles. Teaching and strengthening parental skills may be of particular importance since parents may be contributing to the vulnerability of their children. The focus of family prevention interventions may be predominantly behavioral, affective or cognitive. There are few family oriented prevention programs with adequate efficacy studies. Some programs have been developed in other areas, but have not been tested in the area of substance abuse. Others have focused on substance abuse and outcome evaluations, but are not controlled studies. Some interventions have been tested in highly functional and motivated parents but not with families at risk for drug abuse. Many studies do not have longitudinal follow-up to enable the determination of long term program effects. Complicating matters is the fact that many of the family studies have small numbers of subjects and are under powered from a statistical perspective. In addition, families can play a risk and/or protective role in terms of the initiation of substance abuse by offspring and it is necessary to understand both of these roles. Family predictors of drug use may also differ by race or ethnic group. Hawkins and colleagues (1992) found significant differences between black, white and Asian American families on measures of family predictors and the initiation of drug use for preadolescents. Some controlled studies for family prevention/intervention models that have had positive results are the Focus on Families Project (Catalano and colleagues, 1992); Preparing for the Drug Free Years (Hawkins and colleagues, 1988); Family Effectiveness Training (Szapocznik and colleagues, 1989); and the Strengthening Families Program (Kumpfer and associates, 1993). The targeted children for these models range in age from three through fourteen. An additional issue which needs to be addressed in family prevention intervention studies is attrition of parents or dropouts from the study design. In addition, the issue of low participation needs to be addressed. Forehand, Middlebrook, Rogers and Steffe (1983) examine parent-training studies to determine the dropout rate of parents who were being taught to modify their children's problem behavior. The overall rate was 28% in those studies that reported the drop-out rate. They noted that certain types of assessment and treatment may be differentially associated with drop-out rates. For example, although skill practice is important in teaching parenting skills, parents may feel uncomfortable engaging in this component and may drop out. Areas of Interest The focus of this PA is to develop and test, under controlled conditions, theory-based drug abuse prevention interventions models for the family to lower risk factors, enhance protective factors, and prevent drug abuse behaviors. Prevention intervention strategies for families should entail a comprehensive approach to their needs at the Universal, Selective and Indicated levels. Specifically Universal prevention interventions are targeted to the general population group which share a general risk to drug abuse. Selective prevention interventions are targeted to individuals or a subgroup of the population with well defined risk factors within their life profiles and whose risk to resilience status to developing substance abuse disorders is significantly higher than average. Indicated preventive interventions are targeted to individuals or subgroups who are identified as having minimal but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction, or with biological markers indicating predisposition for substance use disorders AND who have not met diagnostic levels for drug abuse or dependence according to DSM-IIIR or DSM-IV. These models may be: (1) theory-based models which have been tested for efficacy in controlled studies in other fields such as juvenile delinquency, but have not been tested specifically for the prevention of drug abuse; (2) theory-based family-focused intervention models in the drug abuse field which have been developed, but have not undergone rigorous controlled study; and, (3) highly novel and innovative theory-based models for family intervention. Studies should be theory driven. The application should discuss the theoretical background of the issue(s) and the theory underlying the proposed intervention. Studies should assess an intervention(s) against an appropriate control group(s) into which families are randomized. If appropriate all of the children in the family should participate in the intervention. Applicants are encouraged to use a combination of quantitative and qualitative methods for data collection and analysis. State-of-the-art techniques in study design, sampling procedures, power analysis, implementation, instrumentation and measurement, data collection, quality control, client tracking, follow-up, and mediational and outcome data analysis should be addressed in the application. Applicants should focus on families who live in communities that have multiple risk factors such as high rates of unemployment, crime, violence, drug trafficking, drug abuse, school dropouts, high teen pregnancy, etc. Applicants should give an adequate description of the community and target families in order to demonstrate level of risk. Applicants are encouraged to develop collaborative arrangements with community groups and institutions. Since retention and attrition have been of concern in previous research studies of family interventions, applicants should propose procedures to attract and retain families in the study and should specify efforts to follow-up study drop-outs. Applicants should make a thorough analyses of attrition, retention and follow-up issues. Included in this assessment should be an analysis of the reasons for attrition or non-compliance of study participants and measures for estimating the effects of differential attrition. Applicants should be prepared to identify at what points in the study subjects do not show up or drop out, the demographics and previous drug using backgrounds of these subjects, reasons for dropping out and then describe efforts to follow-up subjects. Studies should be able to identify and assess the role played by risk and protective factors within the family that either aid or hinder family participation in proposed experimental studies of drug abuse prevention. Multi-year follow-ups of study cohorts should be conducted in order to ascertain long term effects of the intervention. In considering future issues of knowledge transfer to the clinical field, it is important to address the issue of cost/benefits by identifying the costs and benefits associated with exposure to the program interventions. Appropriate cost-benefit and cost effectiveness methods for describing and estimating effects should be employed. The following themes are of interest and should be considered in the development of a grant application: o Ethnic and cultural considerations Research is needed to test family interventions which are ethnically, culturally, religiously and/or racially relevant to family members. This means more than hiring staff of the same ethnic and/or racial background as the target population. Applicants must demonstrate that the development and testing of specific intervention(s) proposed are theory-based models which are derived from the understanding of ethnic, cultural, racial and/or religious norms and influences on the family. o Interventions with nuclear and extended families Many interventions focus on strengthening family skills and focus specifically on the parent(s). However, intervention research is also needed which may include extended family -- those persons who are also influential in the life of the child such as grandparents, aunts, uncles, siblings, virtual parents, etc. These people may live in the same household or they may live in separate households. o Interventions relevant to functional level of the family Interventions need to be tested with families at different levels of functioning. Determination needs to be made regarding what kinds of interventions will work based on the level of functioning of the family. For example, parents who take drugs themselves, and/or are physically or emotionally abusive towards their children, and/or may have a DSM IV diagnosis of depression, psychosis, etc. may not be able to utilize "established" family interventions. Research is needed to develop and test family prevention interventions which focus on the most at-risk dysfunctional families and what works for them in helping to prevent drug abuse in their children. o Multiple phase interventions vs. single phase intervention Studies regarding the "dosage" of interventions need to be conducted. For example, what are the enduring effects of a single phase family intervention (e.g. a series of 10 sessions) compared to a multi-phase intervention (multiple series on a yearly basis; booster sessions, etc.)? Studies also need to be conducted on the interaction of "dosage" and level of family functioning. For example, the more dysfunctional families may need a higher "dosage" of family intervention. o Comparisons of influences of peer social networks and family Peer social networks may function as either positive or negative influences in terms of drug abuse prevention. Families often feel that they are in competition with peers and feel powerless in the face of negative peer influences. Studies need to be conducted to test how strengthening families through theory-based preventive interventions can counteract negative peer influences. o Comprehensive "systems" approaches Studies need to be conducted using a "systems" approach with multiple levels of interventions which can have a synergistic affect. This includes research of various combinations of interventions such as family and school; family, school and community and other combinations of components. Particular emphasis is placed on the "macro" contexts of community interventions such as how boys and girls clubs and other supportive community family services which can be incorporated into prevention efforts. o Ages and developmental stage of children Research has indicated that school-based prevention intervention may be effective during late elementary or during the middle school years. However, we know little about the relationship between appropriate ages and stages of child development and the type of family prevention interventions selected. At what age and/or stage of the child's development are prevention interventions most effective? Can family prevention interventions be effective for children entering elementary school as well as adolescents entering high school? Applicants are encouraged to study different and distinctive family interventions and their cumulative effects based on the level of family functioning and the age and developmental stage of the children. o Gender issues Most school-based and family prevention interventions have not been gender specific. It is also not known whether some of the risk and protective factors are gender related and if the nature of prevention intervention needs to reflect this. Some major risk factors for girls (more so than boys) are childhood sexual abuse, eating disorders, and anxiety and depression. This prompts the question: Do boys and girls require different interventions and at what age or stage of development should gender specific interventions within the family be targeted? There is also little known about family prevention interventions based on the gender of the parents and the effectiveness of these interventions. It is not known what kinds of family interventions would be most effective based on the gender of the child and/or parents. o Longitudinal and Cross Sectional Studies Longitudinal and cross sectional studies with tests of the effects of booster sessions or differing levels of intermittent intervention are important to examine in order to assess long-term effects of drug abuse prevention interventions focused upon families. o Methodological and Measurement Studies Applicants may need to develop methodologies and measures that are sensitive to family interventions. These include innovative research designs, sampling and tracking plans to identify, access, recruit, engage, intervene with, retain, and follow-up families and children/adolescents at highest risk; and innovative applications of state-of-the-art data analytic procedures. Applicants may also develop new instruments and scales appropriate for family prevention intervention research. Scales and measurements that have been "proven" with other types of families may be tested for validity and reliability for families with drug abuse as a risk factor or scales and measurements may be tested for families with different racial/ethnic backgrounds. Applicants may also test new techniques and/or technologies for accruing family data more efficiently and economically (e.g. Audio-CASI - audio-enhanced Computer Assisted Self Interview technology which allows subjects to listen to questions on earphones, view questions on a personal computer screen or list and view at the same time and record their answers via labelled keys on the computer.) o Technologies of Intervention Studies need to be made of family prevention interventions using new technologies of intervention delivery compared to traditional talking or educational family prevention interventions and/or compared to various combinations of new technologies and traditional methods. The use of these technologies such as video tapes, television, computers, interactive disks, etc. needs to be theory-based. New technologies of delivery may be developed or technologies that have proven effective in other areas may be modified and applied to family prevention interventions. 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 The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms 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, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710, Bethesda, MD 20817 (for express/courier service) telephone 301/710-0267, email: [email protected]. 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 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 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria Criteria for scientific/technical merit review of applications will include the following: o scientific or technical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research, including cultural relevance to the target populations and evidence of familiarity with relevant research literature; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research including but not limited to prevention research, family research, statistics, and cultural relevancy o availability of the resources necessary to perform the research; o appropriateness of the proposed budget, staffing plan and time frame to complete the project; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research; o methods for the recruitment and retention of subjects; efforts to determine factors that influence refusal rate; strategies to follow-up subjects o adequacy of the data analysis plan The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The following criteria will be considered in making funding decision: scientific merit as determined by peer review; availability of funds; and programmatic priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rebecca Ashery D.S.W. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, Maryland 20857 Telephone: (301) 443-1514 FAX: (301) 443-2636 Internet Address: [email protected] Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, Maryland 20857 Telephone: (301) 443-6710 Internet: [email protected] 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 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 Public Health Service (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. REFERENCES Botvin, G.J., Schinke, S.P., and Orlandi, M.A. (1989) Psychosocial approaches to substance abuse prevention: Theoretical foundations and empirical findings, Crisis (10)1, 62-77. Brook, J.S., Brook, D.W., Gordon, A.S., Whiteman, M., et al. (1990). The psychological etiology of adolescent drug use: A family interactional approach, Genetic, Social & General Psychology Monographs. 116(2), 111-267. Bry, B.H. (1983) Substance abuse in women: Etiology and prevention, Issues in Mental Health Nursing, 5(1-4), 253-272. Catalano, R.F., Morrison, D.M., Wells, E.A., Gillmore, M.R., Iritani, B., and Hawkins, J.D. (1992) Ethnic differences in family factors related to early drug initiation, Journal of Studies on Alcohol, 53(3), 208-217. DeMarsh, J., and Kumpfer, K. (1985) Family-oriented interventions for the prevention of chemical dependency in children and adolescents, Journal of Children in Contemporary Society, 18(1-2), 117-151. Dishion, T.J., Patterson, G.R., and Reid, J.R. (1988) Parent and peer factors associated with drug sampling and early adolescence: Implications for treatment, National Institute on Drug Abuse: Research Monograph Series. 77, 69-93. Dishion, T.J., Reid, J.B., and Patterson, G.R. (1988) Empirical guidelines for a family intervention for adolescent drug use, Journal of Chemical Dependency Treatment, 1(2), 189-224. Forehand, R., Middlebrook, J., Rogers, T., Steffe, M. (1983) Dropping out of parent training. Behaviour Research & Therapy. 21(6), 663-668. Hawkins, J.D., Catalano, R.F., Brown, E.O., Vadasy, P.F., Roberts, C., Fitzmahan, D., Starkman, N., Ransdell, M. (1988) Preparing for the drug (free) years: A family activity book. Seattle, WA: Comprehensive Health Education Foundation. Kumpfer, K.L. (1993) Strengthening America's Families: Promising Parenting Strategies For Delinquency Prevention: User's Guide, Office of Juvenile Justice and Delinquency Prevention, Office of Justice Programs, U.S. Department of Justice, September 1993, NCJ140781. Szapocznik, J., Santisteban, D., Rio, Arturo, Perez-Vidal, A., Santisteban, D., Kurtines, W.M. (1989) Family Effectiveness Training: An Intervention to Prevent Drug Abuse and Problem Behaviors in Hispanic Adolescents, Hispanic Journal of Behavioral Sciences, 11(1), 4-27. Tarter, R. (1988) Are There Inherited Behavioral Traits that Predispose to Substance Abuse? Journal of Consulting and Clinical Psychology, 56(2), 189-196. .
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