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15 SUPPORTING THE SCIENTIFIC INFRASTRUCI~URE FOR PREVENlION RESEARCH The National Institute on Alcohol Abuse and Alcoholism now allocates $5.5 million, approximately 9 percent of its total budget for extramural research and research training, to prevention research (including research on safety and trauma). The most common form of research support is the investigator-initiated (ROT) project grant. The kinds of research topics that are investigated under this mechanism include early intervention, risk precursors, high-risk groups, health promotion, prevention modalities, the influence of law and policies, and other miscellaneous topics. One of NIAAA's 12 alcohol research centers is devoted exclusively to prevention. Almost all of the prevention research projects currently funded by the institute are devoted either to basic or to applied research in the early hypothesis-testing stages. In the 1970s, NIAAA supported several communi~r-based intervention programs through its Division of Prevention; however, the Prevention Demonstration and Education Program was discontinued when funding for community treatment and prevention programs became part of the block grants for the states. Funding decisions on the community-based prevention research grants that NIAAA did fund were ~rimarilv based on the perceived quality of the proposed intervention components, with little effort made to ensure sound evaluation. Consequently, information about outcomes or intervention efficacy was limited. Since then, however, much has been learned about outcome evaluation. The experience and sophistication gained through the demonstration and education research grants programs funded by the National Heart, Lung, and Blood Institute (NHLBI) and by the National Cancer Institute (NCI) have provided new insights into the way future alcohol problem prevention programs might be designed, implemented, and evaluated. . ~ ~ , Federally directed funding for community prevention programs again became available after the passage of the Omnibus Anti-Drug Abuse Act of 1986. Under this act, $24 million was appropriated for demonstration projects administered by the Office of Substance Abuse Prevention (OSAP) working directly under the administrator of the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA). To date, 131 demonstration projects have been initiated. Program evaluation, however, was not included as a requirement in the initial announcement. These demonstration projects are sponsored mainly by local community organizations (55 percent) and by state and county agencies (22 percent). University-based programs account for only 12 percent of the total. Although there has been an effort on the part of OSAP to institute outcome evaluation through contract mechanisms, at this time it is unclear whether such remedial after-the-fact action will be sufficient. There may not be enough expertise in the contract research community to meet this challenge. Should the federal government decide to continue this prevention demonstration program on substance abuse (both alcohol and drug), it should specify an outcome evaluation component as necessary for every funded site. The existing OSAP demonstration programs are in the early stages of applied research (i.e., "component" research) and are heavily targeted toward special populations. Yet without outcome evaluation, intervention effectiveness cannot be assessed; in addition, the testing of hypotheses, if it is assumed that the programs were conceived according to existing theory and basic research knowledge, will not be possible. Prevention trials should -309

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become an established tradition at NIAAA, as they are at the National Institutes of Health (NIH). A significant opportunity now exists for NIAAA, the National Institute on Drug Abuse (NIDA), and OSAP to conduct controlled prevention demonstration projects with well-designed evaluation components. Future funding of prevention demonstration projects under federal anti-drug abuse initiatives should include at least a 5 to 20 percent set-aside for the joint design and evaluation of prevention trials by NIAAA, NIDA, and OSAP. Such controlled prevention demonstration projects require participation by both program design and outcome evaluation researchers. A central position for researchers in developing the total program has been a key factor in the success of NHLBI and NCI community trials. Mechanisms of Support for Prevention Research The traditional mechanisms of federal research funding (investigator-initiated ~ROls," center grants, etc.) are appropriate for funding basic research and much of the applied research in prevention. The kinds of needed studies that can be supported readily in these ways include pilot projects, prototype studies, controlled intervention trials, and studies of defined populations. Although NIH also uses traditional mechanisms for the support of community-based demonstration and education research projects, the cost of such projects relative to the total research budget of NIAAA might make these funding mechanisms somewhat unrealistic. The committee recommends the following: Major preventive trials involving comprehensive, multiyear research efforts at several sites are necessary to establish the effectiveness and generalizability of interventions aimed at preventing alcohol problems. Funding such trials through a separate budget line, for both new and recurring initiatives, would be preferable to traditional mechanisms of support. . Outcome evaluation should be specified as an integral part of any program. Cooperative agreements of the type suggested for treatment research (see Chapter 16) would help to standardize methodology and coordinate research directions. There is often a need for rapid review of a prevention research proposal. For example, obtaining baseline data when new laws are passed is difficult, given the time allotted for proposal review. Response to changes in the legal environment (e.g., tax hikes or labeling laws) also requires rapid response. The committee proposes the development of a mechanism to expedite the review of proposals for the study of rapidly implemented legal and regulatory interventions. Infrastructure Needs A network of expertise in outcome evaluation is needed to help NIAAA and scientists interested in alcohol prevention research. The expertise and experience developed through the Planned Approach to Community Health (PATCH) program of the Centers for Disease Control (CDC), the Stanford Center for Research in [Disease Prevention, and other research teams that have conducted successful research demonstration programs should be marshaled in this effort. -310

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The committee recommends the following: A successful program should develop a research team that includes scientists with expertise in alcohol-specific issues, research design and evaluation, and implementation. The training of personnel in all of these areas is needed. The communications and community assistance divisions of OSAP might also be directed toward these areas of expertise. NIAAA should take the lead in coordinating alcohol prevention/intervention research efforts in collaboration with other federal agencies including the Veterans Administration, the Department of Defense, the Department of Transportation, the Department of Education, and other branches of the Department of Health and Human Services. Prevention demonstration and education research projects similar to the Stanford University Three-communit~rlFive-city projects could be developed through the Department of Defense. Research on the effects of changes in regulation and policy might be jointly sponsored by NIAAA and the Department of Transportation. Community Initiatives is needed that can respond to prevention efforts arising from A support mechanism community initiatives that represent new or unique research oppor~un~es. en research funding mechanisms may not be suitable for these novel initiatives. Programs and activities that communities develop themselves are more likely to utilize available resources and may have a greater chance of long-term survival than programs initiated in response to outside funding, utilizing researchers who are not part of the community. It is proposed that initial funding be made available to communities for planning and development if the local initiative is judged to be a worthwhile research opportunity. This initial support could be followed by funding for assistance with implementation, data collection, and outcome evaluation. In all of these efforts, the community would be provided with help from collaborating researchers. The initial planning and development phase could have a fixed cost but need not be time limited. In this way the community would not be compelled to apply for funds to implement a program before adequate community support existed. The cooperative efforts of OSAP and NIAAA could be especially helpful in this regard. The provision of technical expertise to prevention programs that are already under way would enable a community to undertake program evaluation and outcome data collection. This kind of funding would ensure that outcome evaluation is performed and, consequently, that what is learned from a given initiative is transferable to other communities. Such a support mechanism for community initiatives in prevention research does not presently exist. However, if it were instituted, it would substantially increase the benefits obtained from prevention research and would stimulate the initiation of local prevention activities. Most of this opportunity is now missed. Again, close cooperation between OSAP and NIAAA could be critically helpful to committees and prevention researchers. Cooperative Studies A research strategy that ultimately leads to prevention programming will require a collaborative design and highly coordinated analyses. Collaborative studies involving several -311

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research laboratories have been successful. An example is the multihospital studies of the phenothiazine treatment of schizophrenia in the early 196Os. A system is needed that will connect research groups in cooperative studies that combine individual strengths, and support strong theoretical and methodological integration, while allowing for continued independence as appropriate. It is necessary to determine with what degree of success this has been accomplished in other research areas. For example, in recent years, foundations have supported small networks or consortia of selected research teams with longitudinal interests in factors relating to mental health. In the alcohol field, federal support is needed on a larger scale than is likely to be provided by private sources. Therefore, various mechanisms (consortia, cooperative agreements, etc.) should be explored as NIAAA seeks to provide leadership in this area. With such leadership, a structure should emerge that fosters the exchange of information among research groups in the early and intermediate stages of their preventive research activities and perhaps lead to the planning of joint research projects. NIAAA is to be commended for the organizational steps it has taken to foster cross-fertilization from different investigative areas. It should continue in this endeavor. Indeed, prevention research could not proceed if it were isolated from other research areas. The fragmentation of different aspects of NIAAA's mission could result in lost or delayed research opportunities--a risk shared by other research agencies. The committee also commends NLAAA for the steps it has taken, and should continue to take, in the direction of integrating biobehavioral, biomedical, psychosocial, and prevention research categories. The committee recommends that NIAAA continue to work actively to promote collaborative strategies and new prevention research initiatives. In addition, the committee makes the following recommendations for a collaborative prevention research strategy: Collaborative examination is required of existing longitudinal data bases. Analyses are needed in which a laboratory would attempt to replicate specifically chosen findings from other laboratories. - Collaborative design of new studies should be undertaken, and this process should specifier the population samples front which the data are to be collected. Planning should include the possibility of extending existing longitudinal data bases to allow for additional follow-up. Experimental interventions can be analyzed by taking known predictors of substance use into account. In addition, some existing data can be reanalyzed, and new preventive intervention trials can be designed which are directed at early antecedents that have not yet been addressed. The purpose of these experimental interventions is to understand the function of the specific predictors in the causal paths leading to heavy alcohol use and other outcomes. After preventive intervention evaluation studies, researchers will be in a position to recommend a national policy on alcohol abuse and to help design and implement prevention interventions aimed at specific antecedents. -312