RFA-AA-98-003: TREATMENT FOR ADOLESCENT ALCOHOL ABUSE AND ALCOHOLISM

Department of Health
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TREATMENT FOR ADOLESCENT ALCOHOL ABUSE AND ALCOHOLISM Release Date: March 13, 1998 RFA: AA-98-003 P.T. National Institute on Alcohol Abuse and Alcoholism SAMHSA Center for Substance Abuse Treatment Letter of Intent Receipt Date: May 8, 1998 Application Receipt Date: June 12, 1998 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA), in conjunction with the Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA), seeks applications that propose research which will contribute to the identification and development of efficacious treatment interventions and services for adolescent alcohol abusers and alcoholics. Two types of treatment studies may be submitted under this RFA: (1) those that are theory driven and based on experimental design (efficacy studies) and (2) those that assess practice as usual in health service settings (effectiveness studies). The primary aim is to develop a knowledge base derived from efficacy research, i.e., manualized, theory-driven, randomized controlled clinical trials of adolescent treatment interventions. An important secondary aim is to assess the effectiveness of standard adolescent treatment practice utilizing an equally rigorous approach. Projects also may identify, develop, and/or test related screening, assessment, and diagnostic instruments or may propose pretrial studies that investigate, for example, predictors of treatment outcomes in specific subgroups of adolescents. 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 Request for Applications (RFA) is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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 Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Because the nature and scope of the research proposed in response to this RFA may vary from pilot studies and secondary analyses to clinical trials, it is anticipated that mechanisms of support will vary also. Research support may be obtained through applications for a regular research project grant (R01) up to five years. Applicants may also submit Investigator-Initiated Interactive Research Project Grants under this RFA. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications from investigators who wish to collaborate on research. Program Project Grant applications (P01) will not be accepted under this RFA. Research support may also be obtained through Exploratory/Developmental grants (R21) and Small Grants (R03), which are limited to two years for up to $70,000 per year and $50,000 per year, respectively, for direct costs. In addition to citing the above RFA number in their applications, R21 or R03 applicants also need to cite the program announcement number (PA-91-89) for Exploratory/Developmental Grants for Alcoholism Treatment Assessment Research or the program announcement number (PA-91-008) for Small Grants. Potential applicants for Exploratory/Developmental Grants, Small Grants, or Investigator-Initiated Interactive Research Project Grants may obtain copies of the specific announcements from the NIAAA Home Page at http://www.niaaa.nih.gov or from the Office of Scientific Affairs, NIAAA, Willco Building, Suite 409, 6000 Executive Boulevard MSC 7003, Bethesda, Maryland 20892-7003, telephone: 301-443- 4375 or FAX 301-443-6077. Further information on grant mechanisms and areas of research interest may be obtained from program staff listed in the Inquiries section of this RFA. FUNDS AVAILABLE It is estimated that nearly $4 million in total costs will be available to support approximately 15 to 18 grants under this RFA. This level of support is dependent on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of NIAAA, the award of grants pursuant to this RFA also is contingent upon the availability of funds. Investigators who wish to submit an application that exceeds $500,000 for direct costs in any one year must obtain written approval from NIAAA prior to submitting an application. RESEARCH OBJECTIVES Background Alcohol is often abused by adolescents and frequently results in adverse consequences. It has been implicated, for example, in adolescent traffic deaths, suicides, homicides, and other fatal injuries. Risk for alcohol-related consequences increases with each grade in school. School-based 1996 Monitoring the Future data (Johnston et al., In press) indicate that the prevalence of adolescents who had consumed five or more drinks consecutively during the previous two weeks increased with grade: 17 percent of boys and 15 percent of girls in the 8th grade, 27 percent of boys and 22 percent of girls in the 10th grade, and 37 percent of boys and 24 percent of girls in the 12th grade. A 13-year longitudinal study of New Jersey suburban adolescents identified three distinctive patterns of substance use among youth: (1) consistently low use, (2) heavy alcohol and/or drug use followed by low use at 21 years of age, and (3) heavy alcohol and/or drug use in adolescence that persists at 21 years (Bates & Labouvie, 1995). By 21 years of age, 53 percent of the New Jersey sample manifested no problems with alcohol, drugs, or depression. Of the remainder, however, 35 percent received an alcohol abuse or dependence diagnosis, 14 percent were positive for marijuana or cocaine abuse or dependence, 18 percent for depression, 9 percent for adult antisocial behavior, 16 percent were comorbid for some combination of these (Johnson, 1995). Other general population surveys (Kessler 1996, Grant, 1997) as well as an inpatient treatment study (Stewart and Brown, 1995) reveal unexpectedly high and possibly increasing levels of alcohol abuse or dependence among adolescents. Particularly germane to the importance of providing effective alcohol treatment to adolescents is the recent finding that the earlier the age of onset of first alcohol use, the greater the probability of developing alcohol dependence during the life course. The prevalence of lifetime alcohol dependence was found to steadily increase with decreasing age of onset of first alcohol use. For example, 47 percent of respondents in a national household survey who first used alcohol at 13 years of age met DSM-IV criteria for lifetime alcohol dependence as compared with only 11 percent of respondents who reported first alcohol use at age twenty (Grant & Dawson, 1997). In light of these findings, NIAAA and CSAT have initiated a program of extramural research to develop efficacious treatment interventions and to identify effective treatment programs for adolescents with serious alcohol problems. This RFA invites applications to conduct preclinical or clinical research that leads to identification of efficacious treatments and treatment processes for adolescents with primary alcohol-related problems, abuse or dependence. This criterion does not exclude recruitment of subjects with co-occurring conditions and problems as long as outcome measures attend adequately to alcohol-specific behaviors and consequences. The ultimate goal is to identify which types of treatment approaches are most efficacious or effective for which subgroups of adolescents with a primary alcohol-related problem. Areas of Research Interest The objective of applications funded under this RFA is to conduct research that contributes to the efficacy of treatment interventions and the effectiveness of treatment programs for alcohol abuse and dependence in adolescents. These objectives can be met through preliminary observational or experimental studies or secondary analyses of existing data sets as well as through clinical trials designed to determine the efficacy/effectiveness of particular interventions or combinations of interventions. Applicants who propose to assess the impact of interventions not previously tested among adolescents are encouraged to initiate their project with pilot studies that develop formal measures and treatment manuals. In addition, they should assess feasibility of the proposed research design and recruitment plan. Although exploratory or purely empirical studies may be appropriate in some phases of treatment research, clinical trials to test specific interventions should be theory-driven whenever possible. Formal theories postulating mechanisms of action for a particular intervention may be drawn from multidisciplinary sources such as the behavioral, biomedical, developmental, and/or social sciences (Petraitis et al. 1995), for example, Jessor"s (1985) problem behavior theory, Bandura"s (1986) social learning theory, Flay & Petraitis’s (1996) theory of triadic influences, or family interactional theory (Brook et al. 1990). In studies that evaluate the effectiveness of one or more currently available adolescent treatments, program theory may be formalized to make explicit and testable providers assumptions regarding factors leading to favorable treatment outcomes (Moos, Finney, and Cronkite, Chapter 12, 1990). The following discussion offers examples of research topics. Screening and Assessment Background. Over the past decade, a variety of standardized instruments have been developed specifically to evaluate adolescents in need of alcohol or drug abuse treatment (McLellan and Dembo, 1993, Winters & Stinchfield, 1995). These instruments include an array of screening and diagnostic tools, comprehensive multiscale assessment inventories and interviews, and assessment systems that combine instruments into a unified clinical process for screening, diagnosis, treatment planning, and referral (Rahdert, 1991, Winters and Henly 1994). Standardized instruments have also been developed that assess post-treatment outcomes such as coping responses to chronic life stressors and high risk situations (Moos, 1993, Myers and Brown, 1996, Timko et al., 1993). Examples of research areas: o An important process will be to evaluate the relative reliability, sensitivity, specificity, and validity of the array of available instruments in different settings (e.g., primary care or pediatric clinics, schools or other community settings, alcohol/drug treatment programs, referral systems) and among different subgroups of adolescents (e.g., children of alcoholics, polydrug abusers, adolescents with conduct disorder, delinquents, minority group members, teenage parents). o Equally important will be to determine which instruments yield adequate predictive validity and measurement sensitivity for predicting behaviors such as response to treatment, treatment compliance, and treatment outcome. The ultimate goal should be to identify minimal batteries of standardized instruments both for clinical and research applications. o NIAAA also encourages development of new instruments to assess theoretically relevant areas for which adequate standardized measures do not yet exist. Treatment Interventions Background. A variety of interventions have been developed to reduce serious alcohol and alcohol-drug problems among adolescents (Adger, 1991, Wilkinson & Martin, 1991). These are available, for example, in schools through counseling and student assistance programs, in juvenile justice systems through family education, adolescent diversion, and post-adjudication programs, in health systems through emergency room interventions, and in national Outward Bound wilderness programs that target high risk youth (Klitzner et al., 1992). In addition, there are many tertiary care programs designed specifically to treat adolescent substance abusers (e.g., Brown et al. 1992, DelBoca et al., 1995). Despite the proliferation of treatment interventions, their efficacy is largely untested. The recently developed instruments for adolescent screening and assessment (McLellan & Dembo, 1993, Klitzner et al., 1992, Rahdert, 1991, Wagner & Kassel, 1995, Winters & Stinchfield, 1995) provide tools to initiate clinical trials designed to determine the short- and long-term benefits of treatments for adolescents alcohol or alcohol-drug abuse. Three types of randomized clinical trials are encouraged: (1) efficacy or effectiveness clinical trials which standardize and evaluate components currently used in treatment programs for adolescents, (2) efficacy trials which develop and test new interventions, or new combinations of interventions, through experimental clinical trials, (3) efficacy or effectiveness trials which introduce into existing treatment programs interventions determined to be efficacious in previous clinical trials of adults. Cost effectiveness studies that assess the relative social and economic costs of comparison conditions in clinical trials (types 1 and 3 above) are welcome under this RFA. For those applicants considering the inclusion of a cost-effectiveness component, it is advisable to seek the collaboration (not just consultation) of a health economist. Also welcome under this RFA are projects that investigate the relative effectiveness of competing treatment strategies for specific forms of disorders and affected populations. Examples of research areas: o In the absence of tested adolescent-specific interventions, adult treatment approaches have been widely adopted in adolescent treatment. There is a need to develop and test interventions tailored to the developmental and social needs of adolescents. These may be either novel approaches (as long as theoretically or empirically justified and assessed in an initial pilot study) or may modify common adult interventions including: motivation enhancement therapy, stress management, cognitive-behavioral therapy (e.g., social skills training, behavioral family therapy, behavioral self-control training, coping skills training), and the 12-step Minnesota Model approach (Wagner & Kassel, 1995). o Initial research funded by the National Institute on Drug Abuse has demonstrated that family-based intervention is effective in treating adolescent drug use (Liddle & Dakof, 1995). "Integrative" models in particular have proven superior to traditional adolescent substance abuse treatment. These multidimensional, multicontextual family-based approaches intervene with several people in the adolescent’s social networks and intervene with problem behaviors in addition to substance abuse. It will be important to determine which family therapy approaches are most efficacious/effective for adolescents with a primary diagnosis of alcohol abuse or dependence and whether any of these are more effective than other single intervention therapeutic strategies. o Adolescents in substance abuse treatment constitute a remarkably heterogeneous population. Not only do they vary from adults in demographics, lifestyle, developmental issues, and patterns of abuse, they differ significantly among themselves in severity of alcohol abuse and co-occurring conditions such as polydrug use, affective, and conduct disorders (Brown et al., 1996, Sher, 1991, Wilkinson & Martin, 1991, Zucker, 1994). Applicants are encouraged to measure variables that represent significant subgroups. Such variables not only may identify subgroups that vary in response to treatment but also can serve as covariates in analyses of alcohol-specific outcomes. Further, such variables may be used to assess the impact of an alcohol-specific intervention on concurrent conditions or behaviors. Examples of these variables include family history of alcoholism and related conditions, developmental social and biological problems, concurrent or previous psychiatric disorders, and concurrent or previous addictions, including eating disorders. Studies are welcomed that focus on targeting treatments to subtypes of adolescents such as those with alcohol problems only, those who are children of alcoholics, or those with primary alcohol problems who also have concurrent or previous depression, eating disorders, behavior disorders, and/or other substance abuse disorders. More severely affected adolescents may benefit from concurrent treatment that targets specific problems such as severe alcohol dependence, depression, or conduct disorder. Pilot studies that assess the efficacy and safety of promising combined pharmacological-behavioral therapies in adolescent treatment also are invited. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is NIH policy 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 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 have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and 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. LETTER OF INTENT Prospective applicants are asked to submit, by May 8, 1998, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIAAA staff to estimate the potential review workload, identify potential reviewers, and avoid conflict of interest in the review. The letter of intent is to be sent to: RFA: AA-98-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 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 from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: asknih@od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) 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, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for support mechanisms other than R01 must cite the relevant program announcement on line 2 in addition to listing the current RFA. Page limits and limits on size of type are strictly enforced. 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 Center as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included in the application material. Submit a signed, typewritten original of the application, including the checklist and three signed photo copies in one package 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 also be sent to: RFA-AA-98-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Applications must be received by June 12, 1998. If an application is received after that 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 and must be prepared in the format of a revised application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the Institute. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institute in accordance with the review criteria stated below. As part of the initial merit review, a streamlined review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications which are fully discussed and judged to be highly scientifically meritorious will be assigned a priority score. Applications which are not scored will be withdrawn from funding consideration. The second level of review for scored applications will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made 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 in the assignment of the overall score. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Will proposed subjects manifest symptoms of alcohol abuse/dependence? Do outcome measures assess alcohol-specific behavior and consequences? (Note: Inclusion of polydrug users or non-alcohol-specific outcome measures are allowed as long as the focus of the study is alcohol.) Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? If the project is a replication, does it contribute to confirming efficacy of an intervention? Does it assess the generalizability of an intervention? Does the project enhance or extend the original theory and/or method? 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)? Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Budget. Is the requested budget and estimation of time and staff to complete the project appropriate for the proposed research? Where applicable, the adequacy of procedures to protect or minimize effects on human subjects and the environment will be assessed. Plans for the recruitment and retention of subjects also will be evaluated as will the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goal of the research. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues of questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Cherry Lowman, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0637 FAX: (301) 443-8774 Email: clowman@willco.niaaa.nih.gov Karen Urbany Division of Practice and Systems Development Center for Substance Abuse Treatment 5600 Fishers Lane, Room 7A-134 Rockville, MD 20857 Telephone: (301) 443-9678 FAX: (301) 443-3543 Email: kurbany@samhsa.gov Direct inquiries regarding fiscal matters to: Edward Ellis Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 44304703 FAX: (301) 443-3891 Email: eellis@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to intergovernmental review requirement of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract 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 routing 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 ADGER, H. , Jr. (1991) Problems of alcohol and other drug use and abuse in adolescents. 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