Reducing Risks for Mental Disorders Frontiers for Preventive Intervention Research (1994) / Chapter Skim
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10 DESIGNING, CONDUCTING, AND ANALYZING PROGRAMS WITHIN THE PREVENTIVE INTERVENTION RESEARCH CYCLE
10 DESIGNING, CONDUCTING, AND ANALYZING PROGRAMS WITHIN THE PREVENTIVE INTERVENTION RESEARCH CYCLE
Pages 359-414
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From page 359... ...
It is apparent from the review in Chapter 7 that an encouraging number of well-designed research programs on the reduction of risk factors associated with the onset of mental disorders do exist. The task over the next decade will be to enlarge that body of work into a prevention science by instituting rigorous standards for designing, conducting, and analyzing future preventive intervention research programs.
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From page 360... ...
The second step is to consider relevant information from the core biological and behavioral sciences and from research on the treatment of mental disorders, and to review risk and protective factors associated with the onset of the disorders or problem, as well as prior physical and mental disorder prevention intervention research. The investigator then embarks on designing and testing the preventive intervention, by conducting rigorous pilot studies and confirmatory and replication trials (the third step)
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From page 361... ...
Problems that are appropriate targets for intervention can include those such as child maltreatment that are serious social problems in their own right but are also risk factors associated with the onset of mental disorders. At this step in the research cycle, the investigator also considers the personal, social, and economic costs associated with the suffering and disability resulting from the problem or disorder.
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From page 364... ...
Giving the community a voice in defining the problem and in formulating the research program and procedures can be done in many ways, such as by having a representative from the community, perhaps a delegate from a service agency, participate with the research team on an ongoing basis (Kelly, Dassoff, Levin, Schreckengost, and Altman, 1988; Weiss, 1984; Snowden, Munoz, and Kelley, 1979; see also the commissioned paper by Fawcett, Paine, Francisco, Richter, and Lewis, and commentaries by Gallimore and Rothman, available as indicated in Appendix D.) Review of Risk and Protective Factors and Relevant Information Tom the Knowledge Base Information regarding the concept of risk reduction and how it can be applied in research programs on the prevention of mental disorders can be obtained from a review of prevention programs in physical health (see Chapter 3~.
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From page 365... ...
This points toward preventive interventions to reinforce these protective factors and thereby diminish the likelihood of stress-induced initial onset of illness. Pilot Studies and Confirmatory and Replication Trials Once the pertinent information has been reviewed, the investigator can begin the process of designing, conducting, and analyzing the research program.
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From page 366... ...
Choosing a Theoretical Model to Guide the Intervention Program To prevent the targeted disorder or problem, the investigator chooses a theoretical model based on the available body of knowledge that addresses one or more of the following factors: · The presence of risk factors and absence of sufficient protective factors correlated with the disorder that may be both causal and malleable, that is, can be altered through intervention. · The mechanisms that link the presence of risk factors and the absence of protective factors to the initial onset of symptoms (which may involve gene-environment interactions)
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From page 367... ...
A variety of questions are typically addressed at this stage in the prevention research process, such as: Is this intervention acceptable and feasible for the targeted population? Has consideration been given to ethical concerns, cultural factors, and linguistic differences?
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From page 368... ...
, in part because individuals who already have the disorder in question must be excluded from the preventive intervention and individuals who are at especially high risk should be included. For most mental disorders, genetic predispositions have only a probabilistic influence on the manifestation of the illness.
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From page 369... ...
Incentives for participation, such as payment for interviews, video tapes of children, printed educational materials, and free transportation, are often presented at this time. Noncompliance and attrition are major issues in prevention research programs.
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From page 370... ...
Such trials may require involvement with community service agencies or organizations of various kinds, including social service agencies, mental health clinics, primary health care clinics, schools, and day care centers all here referred to for convenience as organizations and will definitely require the involvement of many more interveners. Therefore the investigator, although still theoretically in charge, can lose some control over the fidelity of the implementation unless considerable attention is paid to the details regarding the delivery of the intervention and the recording of data.
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From page 371... ...
Additional guidelines to aid in the shaping of productive interorganizational exchange can be derived from the experiences of a team of intervention researchers with extensive experience (Schilling, Schinke, Kirkham, Meltzer, and Norelius, 1988~. They advise that researchers · approach and orient the organization at least six months in advance, · invite suggestions from the organization on research objectives and procedures, · gear operations, if possible, to tangibly benefit the organization's program,
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From page 372... ...
For this trial the investigator turns the carefully tuned intervention program over to the organization that hopes to run it, but leaves the research component in place. This stage in the research cycle is frequently not achieved, but the Centers for Disease Control and Prevention is currently planning to test the Infant Health and Development Program (see Chapter 7 and program abstract, available as indicated in Appendix D)
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From page 373... ...
The goals influence the types of research methodology that will be used, as well as the answers to methodological questions encountered in steps three and four of the preventive intervention research cycle. Questions concerning the structure and duration of the trial and follow-up period, sampling, measurement, and statistics and analysis are considered here, including: What are the characteristics of the population to be used in sampling?
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From page 374... ...
A finding of lower incidence of disorder in the experimental group as compared to higher incidence in the control group is the best way of documenting the effect of a preventive intervention. Although randomized controlled trials remain the optimal design for preventive intervention trials, quasi-experimental time series designs can sometimes permit investigators to capitalize on policy or regulatory changes and conduct natural experiments in the real world, as, for example, with the Intervention Campaign Against Bully-Victim Problems (Olweus, 1991)
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From page 375... ...
Duration of the Tnal and Follow-up The length of the intervention as described above-short enough to be practical and yet long enough to be effective-governs the length of the preventive intervention trial as well. In addition, because a decrease in the incidence of a disorder is the major long-term goal, participants should be followed longitudinally in prospective designs.
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From page 376... ...
But the current practice of short-term support is especially limiting in regard to research on prevention of mental disorders. Lengthy foDow-up periods that delay the reporting of results have disadvantages in terms of scientific practice as well.
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From page 377... ...
The heterogeneity, combined with the low incidence rates of the disorder likely in such a population, creates a situation in which very large sample sizes are necessary to detect any indication of efficacy or effectiveness. Because the effects may seem quite small, the clinical or policy significance of the prevention program may be underestimated.
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From page 378... ...
That to Measure Careful selection of primary outcome measures is essential to the success of a preventive intervention trial. These are usually the measures of changes in the theorized mediating variables, including risk and protective factors, that are assumed to be responsible for the reduction in risk.
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From page 379... ...
Documentation of the changes in risk and protective factors for the child could have been extended for a more complete picture of mediating variables. Although disorder incidence measures were not included in the Perry Preschool Program, it is one of the few research programs to have included long-term outcome measures of any sort.
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From page 380... ...
Without this, the investigator's ability to draw firm conclusions about what would have happened in the experimental group in the absence of the intervention is compromised. The baseline information is also needed to determine eligibility for the program, to ensure that the elements in the prevention program are not already in place in the participants' environment before the experiment, to describe the population to which the results might be expected to generalize, to document the success of the randomization procedures, and, in secondary analysis, to detect those subgroups for which there is differential outcome.
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From page 381... ...
Almost always, a variable can be measured with either technique, but the yield is different. When they are appropriate, continuous measures can increase statistical power, but the crucial issue in deciding on the outcome measures in a trial of a prevention program is that of selecting the most valid and reliable measures available.
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From page 382... ...
Whether the chosen measures are categorical or continuous, they should display high internal consistency and construct validity based on earlier psychometric analyses and research as well as high reliability with different assessors. With the advent of the DSM-III and DSM-III-R, certain comprehensive diagnostic instruments that can elicit all the signs and symptoms of mental disorders have come into general use and provide a means for improving the reliability and replicability of diagnosis.
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From page 383... ...
Having many measurements and diagnostic assessments may compromise the quality control of the measurements. When there are only a few crucial measurements on which the success of a trial depends, the investigator can spend a great deal of time and effort to select the best instruments, provide adequate training and orientation to the assessors, and institute adequate quality control procedures.
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From page 384... ...
A quality control check on raters' blindness can be done by administering a questionnaire to raters at several times during the prevention trial, asking them to make guesses about the assignment of the participants. As is the case in many randomized controlled trials, however, it is simply not possible to blind all assessors to the group membership of the participants.
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From page 385... ...
Considerable interest has been generated recently by the use of random effects regression models as alternatives to repeated measures analysis of variance and covariance or MANOVA designs (Gibbons, Hedeker, Elkin, Waternaux, Kraemer, Greenhouse et al., in press; Laird and Ware, 1982~. In this methodology a separate curve is fit to each participant's response data, using a few clinically interpretable parameters to define the mathematical model for the curve.
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From page 386... ...
Statistical methods of survival analysis are being used in treatment trials and epidemiological studies of onset and natural history (Elandt-lohnson and Johnson, 1980~. Typically, there are individual differences in the susceptibility among participants in any group-based on risk and protective factors-and these differences are reflected in different survival function shapes.
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From page 387... ...
of smoking decreased in the later cohorts, leaving more nonsmoking "survivors" and a higher plateau value. For a given group, the point in time at which its curve reaches the 50 percent point is the median survival time or median onset time.
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From page 388... ...
Depending on the natural history and risk periods for the disorder, hazard curves may grow, recede, or have one or several peaks. Whereas survival and hazard functions can illuminate the changes in incidence of mental disorders among participants in a prevention program, impacts of the program on the severity of the disorders that do develop among participants for whom the prevention program failed, such as the degree of impairment or disability, relapse pattern, or duration of episodes, require the use of prevalence assessments to highlight the differences between the experimental and control groups.
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From page 389... ...
DOCUMENTATION ISSUES For the committee's examination of preventive intervention research programs, it compiled a list of criteria, which appear in Chapter 7, to be
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From page 390... ...
But an even higher standard will be desirable in the next decade of preventive intervention research. For example, efforts will need to be made to assess costs and benefits in a realistic way (see the section on economic issues below)
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From page 391... ...
Throughout the preventive intervention research cycle, investigators must be sensitive to the attitudes, values, beliefs, and practices of the cultural groups with whom they are working, as matters of good science and therapeutic leverage, as well as professional ethics (Kavanagh and Kennedy, 1992; Locke, 1992; Vega, 1992; Galanti, 1991~. However, they must strive for more, namely, a set of skills and a perspective that have become commonly known as cultural competence (Isaacs and Benjamin, 1991; Cross, Bazron, Dennis, and Isaacs, 1989; Lefley, 1982~.
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From page 392... ...
Ultimately, cultural competence specific to prevention will emerge through the conduct of preventive interventions themselves, critical reflection on what does and does not work, and constructive exchanges intended to capitalize on success and reduce the likelihood of future failure. The committee identified a number of points throughout the preventive intervention research cycle at which issues of cultural competence become especially salient and must be addressed.
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From page 393... ...
Attempts to understand risk and protective factors, triggers, and processes regarding the onset of a disorder or problem should allow for the possibility of alternative explanation and circumstances among cultural groups (Neighbors, 1990~. For example, risk factors can be unique to a specific population.
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From page 394... ...
~ Preparing the content, format, and delivery of preventive interventions. Individuals and groups are adapted to ethnocultural niches, defined in familial, social, political, and economic terms.
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From page 395... ...
Though their role has been slightly eroded, family councils among Hmong refugees, who relocated to the United States after fleeing from Vietnam, remain central to conflict resolution and mediation of domestic disputes (Norton and Manson, 1993; Bloom, Kinzie, and Manson, 1985~. Imagine the probability of success of preventive interventions that ignore, or even run counter to, such decision-making processes.
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From page 396... ...
This same lesson is evident in reports of prevention programming among Southeast Asian refugees (Bliatout, Rath, Do, Kham One, Bliatout, and Lee, 1985; Le Xuan and But, 1985; Lum, 1985; True, 1985) , Asian-Americans and Pacific Islanders (Murase, Egawa, and Tashima, 1985)
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From page 397... ...
ETHICAL ISSUES All types of scientific research face challenges in ensuring that their activities adhere to fundamental standards of integrity. Many of these
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From page 398... ...
The development of a specific ethical code for prevention research is premature and perhaps not even desirable. What is needed, however, is a sensitivity on the part of the individual investigator, and of the research community in general, regarding the importance of ethical issues throughout the preventive intervention research cycle.
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From page 399... ...
6~. In addition to being bound by the values and standards that guard scientific integrity and by the IRB policies, preventive intervention research programs must address numerous specific ethical issues regarding participants.
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From page 400... ...
If the group of prevention researchers differs significantly from the community in terms of such factors as social class, race, religion, or politics, what will be the effect on the community? What is informed consent for a community?
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From page 401... ...
Time constraints, economic resources, planning for the research program's termination all of these issues carry ethical implications for how an intervention program is presented and whether or not it is conducted in good faith. · Treat participants with respect and dignity.
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From page 402... ...
Through continued examination of issues of confidentiality, on which opinions now vary considerably, researchers may identify ways to better ensure the efficacy and effectiveness of preventive intervention research programs while exercising responsibility for the welfare of victims and rehabilitation of perpetrators of violence. Obtain informed consent.
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From page 403... ...
Weithorn (1987) concluded that prevention researchers should regard the federal regulations covering informed consent as an important guide, but view them as the minimum adequate standards and not as a substitute for careful reference to the moral principles that underlie them.
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From page 404... ...
Also, involving administrators in the planning of a school intervention program may lead to a commitment for continuing the program beyond its externally funded demonstration phase- itself an ethical issue. Although there is consensus about the importance of ethics in prevention research on mental disorders, ethical accountability in this area has not yet received the emphasis it deserves.
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From page 405... ...
Analysis of costs and benefits can help inform decision makers about which kinds of interventions for mental disorders hold the most promise for yielding net benefits. The basic goal is to reach a decision on whether a particular intervention program is worth undertaking or whether an existing program should be discontinued, expanded, or reduced in scope.
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From page 406... ...
Many potential preventive intervention research programs are consistent with the policy priorities for school districts, and the classroom and teacher resources required to conduct them could be achieved at
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From page 407... ...
Evaluation can show who gains and who loses as well as how big the overall gain or loss actuaBy is. One example of a pioneering benefit-cost analysis of a prevention program is that done for the Perry Preschool Program, a selective preventive intervention (Berrueta-Clement, Schweinhart, Barnett, Epstein, and Weikart, 1984~.
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From page 408... ...
According to the researchers' estimates, by the time experimental group participants reach age 60, they can be expected to have accrued $48,151 more benefit per person than their counterparts in the control groups, assuming they continue to be employed. CONCLUSION If the research standards and methodology outlined here are systematically and rigorously applied within the preventive intervention research cycle and the guidelines on cultural, ethical, and economic issues are carefully considered at each step, prevention research will yield progressively more powerful results over the next decade.
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From page 409... ...
(1990) Ethical issues in evaluating the effectiveness of primary prevention programs.
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From page 410... ...
Intervention research as an interorganizational exchange.
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From page 411... ...
In: Preventing Mental Disorders: A Research Perspective. National Institutes of Health.
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From page 412... ...
(1982) New Directions in Prevention Among American Indian and Alaska Native Communities.
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From page 413... ...
Ethical Issues of Primary Prevention. New York, NY: The Haworth Press.
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From page 414... ...
(1987) Informed consent for prevention research involving children: Legal and ethical issues.
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