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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH 7 Illustrative Preventive Intervention Research Programs Although preventive intervention research is still a relatively young field and formidable tasks lie ahead, the past decade has brought encouraging progress. At present, there are many intervention programs that rest on sound conceptual and empirical foundations, and a substantial number are rigorously designed and evaluated. From a mental health perspective, these interventions are consistent with—even though they do not prove—the hypothesis that serious psychological problems can be avoided by preventive action before the onset of a diagnosable disorder. In this chapter the committee selects a limited number of these interventions to illustrate a range of promising program approaches to achieving diverse prevention goals. This review of preventive interventions is based on three principles presented in earlier chapters in this report: (1) Prevention of the initial onset of mental disorders can be accomplished through intervention programs aimed at risk reduction, which can include both reduction of causal risk factors and enhancement of protective factors. The goal is to address malleable, or modifiable, risk and protective factors related to the onset of disorders, including precursor symptoms, to reduce the incidence of mental disorders or at least to delay their onset. However, even if the interventions fail to prevent a disorder, they may have some effect on reducing the severity or duration of the disorder. (2) Preventive intervention programs can be successfully implemented at all three levels—universal, selective, and indicated—described in Chapter 2. (3) Preventive intervention programs can be initiated throughout the life span.
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH The committee-reviewed numerous prevention programs that were supported by federal agencies and private foundations. A wide net was cast in soliciting nominations, but the search could not be exhaustive. A majority of the prevention programs that currently exist are service programs and demonstrations that have not incorporated rigorous research methodologies. Even those that have an evaluation component usually have not used rigorous standards for assessment of effectiveness. Thus the nation is spending billions of dollars on programs whose effectiveness is not known. Most of the prevention programs discussed in this chapter meet the criteria listed below, including the use of a randomized controlled trial design. Such a high standard lends credence to the results of these studies. These program illustrations demonstrate that rigorous protocols can be applied to complex interventions, yielding tangible outcomes. Many of the prevention programs that were reviewed used quasi-experimental designs. Where their findings provide some confirmatory evidence for a study with a randomized controlled trial design, or where their findings provide new leads in areas where there have been no randomized controlled studies, the information is briefly discussed in the chapter. Also, three well-known service projects that have not been rigorously evaluated are presented to highlight the potential for applying experimental designs to preventive interventions created by practitioners. All prevention program titles are in italics. Titles of programs that met the criteria for use as full illustrations are preceded by an asterisk. These illustrative programs are also listed in Table 7.1 and are abstracted in more detail in the background materials (program abstracts are available as indicated in Appendix D). The programs target different age groups and are arranged here in developmental sequence from gestation through old age. As individuals move from one stage to the next, the developmental tasks facing them change, as does the nature of the risk and protective factors. This life course presentation serves to emphasize the importance of continuity and integration of interventions across the entire life span. Prevention programs that lasted for several years and bridged successive developmental phases or had effects on more than one generation are presented in this chapter at the earliest developmental phase. At the end of each section, several findings and leads that emerged from the review of programs addressing that age group are listed. The order of the points does not imply priority, and the list is not meant to be comprehensive but rather to illustrate the sorts of patterns, problems, and directions for future work that can be learned from such a perspective.
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH CRITERIA FOR EXAMINING PREVENTIVE INTERVENTION PROGRAMS DESCRIBED IN THE LITERATURE As a basis for selecting the illustrative preventive intervention research programs, the committee formulated six criteria. The criteria pertain to (1) the risk and protective factors addressed, (2) the targeted population group, (3) the intervention itself, (4) the research design, (5) evidence concerning the implementation, and (6) evidence concerning the outcomes. Each of these criteria is described in detail below. In addition, Figure 7.1 displays these criteria in a format that may be useful to the reader in future examinations of published prevention programs. Description of the Risk and Protective Factors Addressed A well-documented description of the risk and protective factors addressed in the preventive intervention and how they relate to developmental tasks of the targeted group is a critical scientific first step. Without such specification, the rationale for identifying any group for intervention will be difficult to provide. Furthermore, the accumulation of data about well-documented risk and protective factors is essential to the design of preventive interventions, and the identification of malleable, or modifiable, risk factors is crucial to the success of prevention efforts built on the risk reduction model. In identifying risk and protective factors, the causal status of the risk or protective factor is crucial. Some risk factors may not be causal but are nevertheless useful for identifying and targeting high-risk populations. The risk factors used to target the population may not always be the risk factors that one is attempting to modify through an intervention. Although definitive scientific evidence of the causal role that a risk or protective factor plays in the development of mental disorder is seldom available until an intervention is tried, certain critical pieces of evidence should be in place. For example, there should be epidemiological evidence to suggest that the risk or protective factor is statistically correlated with the incidence or prevalence of the disorder itself. Furthermore, evidence that the risk or protective factor precedes the disorder is an important indication that the factor has at least a potential role in causation. Also, there may be a dosage effect, that is, the stronger the risk factor, the more disorder. In addition, the mechanism or process through which the risk or protective factor potentially operates should be specified. For example, a protective factor may affect risk either directly by operating on the antecedent risk factor itself or indirectly by affecting the strength of the relationship between the risk factor and
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH FIGURE 7.1 A framework for examining preventive interventions. This format might be used as a worksheet in determining the methodological rigor of a specific program.
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH some mental health outcome. A protective factor may also operate by affecting some mediating mechanism that stands causally between the risk factor and the development of mental disorder. Ultimately, it is important that the risk and protective factors addressed in the prevention program be explicitly identified and established as risk and protective factors in rigorous scientific studies. As scientific evidence converges on particular sets of risk and protective factors, interventions addressing them become more plausible and more likely to succeed. Description of the Targeted Population Group A description of the characteristics of the targeted group is another critical ingredient. As described in Chapter 2, universal preventive interventions are provided to entire populations; selective preventive interventions are targeted toward groups or individuals with high lifetime or high imminent risk; and indicated preventive interventions are targeted toward high-risk individuals on the basis of the individual's minimal, but detectable, behavioral symptoms that could later develop into a full-blown mental disorder, or the individual's biological markers that identify him or her as being at especially high risk. Because our knowledge of precursor signs and symptoms of mental disorders is only preliminary (for example, no standardized lists of these exist), it is often difficult in practice to distinguish between selective and indicated interventions. We are just beginning to understand which risk factors contribute in a general way to multiple disorders and which are actually precursor symptoms for a single disorder. For example, in the causal chain leading to conduct disorder, aggressive behaviors at ages 4 to 6 are stable predictors of later problems and could be used to trigger an indicated intervention. Farther along the chain, at ages 9 to 11, academic difficulties also begin to stabilize as predictors of later conduct disorder and substance abuse. At this point the academic problems are not just a general risk factor for multiple disorders; they are also a precursor symptom for conduct disorder and can also be used to target an indicated population. The committee believes that the exercise in distinguishing between selective and indicated targeted populations is a useful one—and has attempted to do it for the illustrations given here—for it allows us to see more clearly where past efforts have been directed and how successful they have been. In addition, the distinction provides clues as to what degree of specification of targeted group tends to produce the best outcomes. Specifying the targeted group is important for evaluating the degree
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH to which the group actually displays the purported risk factors, for evaluating the actual and potential impact of the intervention, and for replicating the intervention. For example, scientific evidence should be provided to indicate that the group targeted actually is a group at risk for a particular disorder, cluster of disorders, or problem, and, if known, the degree to which the group is at risk should also be provided. The targeted group should be described not only in terms of its risk and protective factors but also in terms of a combination of sociodemographic variables, including such characteristics as gender, age, race, socioeconomic status, living conditions, exposure to major life transitions, and family configuration. The number of participants and the distribution of sociodemographic characteristics in various experimental and control conditions should also be specified. Finally, because of potential effects on outcomes, there should be a description of the recruitment process and the consent process. Description of the Intervention Program All too often, treatment interventions as well as preventive interventions lack adequate description. This lack of specification is sometimes due to restrictions imposed by journal publication formats. In other cases, adequate descriptions of intervention protocols, including documents such as intervention manuals and training programs for delivery of the intervention, are simply missing. This is a danger signal, impeding evaluation. Adequate descriptions of the goals and content of the intervention, and of the personnel delivering the intervention, including their professional qualifications and/or training for the delivery of the intervention, are needed. Detailed descriptions of the intervention site, including information on physical surroundings; the institutional and cultural context; special ethical considerations; and special physical aspects of the environment, including equipment or instrumentation, are other elements. The actual methods of delivery must also be described, including the use of any special techniques, such as media devices and learning exercises. In addition, there must be a clear indication of the duration and extent of the intervention, including the prescribed length of exposure to the intervention by individuals or groups, whether booster sessions after the main intervention are required, and if so, at what intervals. Finally, many preventive interventions have multiple components that are designed to work in an additive, sequential, or interactive
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH fashion. Each of the components, modules, or stages ought to be described in enough detail that replication is possible. Description of the Research Methodologies The choice of research methodologies is a major issue in examining preventive interventions and the research trials designed to determine their outcomes. It heavily determines whether evidence is compelling that a preventive intervention could have produced its intended effect. The ideal research design in a preventive trial is a randomized controlled trial of adequate size embedded in a longitudinal study. However, a variety of other designs, including group comparisons such as pretest-posttest, and quasi-experimental designs such as interrupted time series and regression discontinuity, are often employed. Such designs may be particularly necessary for large-scale community interventions. Although such designs have the potential for yielding useful data, they are less desirable than true randomized experimental designs. Such designs also require detailed descriptions of comparison groups, including methods of recruitment and any other information that might allow evaluation of comparison groups. The research design should include appropriate use of statistical methods and account for attrition of participants through appropriate use of weighting procedures, statistical modeling of attrition effects, or the conservative use of full randomized designs even where attrition has taken place (Kraemer, 1992; Cohen, 1988; see also commissioned paper by Kraemer and Kraemer in the background materials, available as indicated in Appendix D). Even when randomized assignment is possible, attrition is still a threat. It is frequently still necessary to confirm that randomized assignment has had its intended effects by comparing experimental and control groups on sociodemographic characteristics and other characteristics in addition to the outcomes. Furthermore, designs that employ appropriate and sufficient baseline measures, such as data on intelligence, personality, and physical health, are highly desirable because variables that appear extraneous are potentially significant. Inclusion of such measures has become standard practice for the evaluation of most randomized trials. Description of the Evidence Concerning the Implementation How well the intended objectives and processes of the intervention were actually implemented needs to be examined even when an
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH adequate, detailed description of the intervention program is available. The critical issue is whether the intervention was delivered in accordance with its design. It is important to assess the degree to which targeted participants actually were exposed to the intervention and, wherever possible, the degree to which there were variations in exposure or dosage. The degree to which the intervention was delivered with fidelity can be determined if evidence is provided through various program data collected by external observers, through detailed program archives documenting contacts with participants, or through knowledge obtained from participants who were targets of the intervention. Description of the Evidence Concerning the Outcomes The final element to be examined is the outcomes. Most fundamentally, evidence should be provided that risk or protective factors have been changed. Without at least preliminary evidence that the intervention was successful in reducing risk factors or increasing protective factors, or in showing that protective factors reduced the strength of the relationship between risk factors and outcomes or affected some hypothesized mediating process, the claim that the intervention had an effect on some aspect of the causal chain leading to disorder becomes less convincing. Other obvious sources of evidence of preventive effects would be an actual reduction in the observed rate of new cases of disorder or a delayed onset of disorder in the experimental group. It is entirely possible for a trial to provide evidence that the incidence of a particular disorder was reduced or the onset was delayed without clearly showing the mechanism of action by which the effect occurred. Accordingly, trials should, if possible, identify evidence not only on rates and age of onset of disorder but also on effects on risk or protective factors. Still other outcomes are important to assess. These include the identification of unanticipated side effects, data regarding the costs and benefits of the intervention, and any benefit-cost or cost-effectiveness analyses conducted as part of the intervention evaluation. However, information on side effects and benefits and costs rarely has been included in published reports. Increasingly, it should become a standard part of the evidence on outcomes. A DEVELOPMENTAL PERSPECTIVE With these criteria in mind, the committee reviewed the preventive intervention research using, as an organizing conceptual framework, an
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH understanding of human development throughout the life span. As mentioned above, each developmental phase brings new tasks to be accomplished; each is accompanied by potential biopsychosocial risk factors as well as opportunities for growth. Just as each individual is continually changing and evolving, risk and protective factors emerge and disappear over time or, if present for a long time, may express themselves differently. Likewise, outcome variables may need to vary through developmental stages. Figure 7.2 illustrates the conceptual framework of the life course of human development, with developmental tasks and corresponding social relationships and settings, such as family of orientation and peer group, which are the appropriate targets and contexts for preventive interventions. (See Table 7.1 for a summary of research programs corresponding to this life course framework.) INTERVENTIONS FOR INFANTS In infancy, the biopsychosocial risk factors that can hinder development include, but are not limited to, preventable infections, disease, or injuries that can cause brain damage, neurodevelopmental disorders, or behavioral disorders; problems of parent-infant attachment or parenting; deprivation of cognitive and language stimulation; economic deprivation; and child maltreatment. The corresponding protective factors of robust health and “good-enough” parenting—coupled with adequate nutrition and shelter—encourage the physical, intellectual, and emotional growth of the child. In recent years, there have been notable increases in infants and children at risk for developmental impairments, and in infants and children already showing such problems (Rickel and Allen, 1987). Unemployment, deteriorating neighborhoods, increased violence, and lack of access to medical care have all contributed to this problem (see Chapter 6 on risk and protective factors). The Center for the Study of Social Policy (1992) concluded that our nation has failed to keep pace with the needs of its youngest citizens: over the 1980s child poverty expanded, births to unmarried teens climbed, more children were living in families with only one parent, and more babies were being born at risk because they were underweight. Although the larger societal and structural issues will require societal and macroeconomic solutions, a number of creative and comprehensive programs have shown that it is possible to address the adverse effects on mothers and children of the heightened risks caused by these social changes. Preventive intervention strategies that have been used during infancy to target babies and their parents include high-quality prenatal
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH FIGURE 7.2 Developmental tasks and social fields for preventive interventions over the life course. Source: Adapted from Kellam, S. G.; Branch, J. D.; Agrawal, K. C.; Ensminger, M. E. (1975) Mental Health and Going to School. Chicago, IL: University of Chicago Press.
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REDUCING RISKS FOR Mental Disorders: FRONTIERS FOR PREVENTIVE INTERVENTION RESEARCH and perinatal care, childhood immunization, regular home visitation, parenting education, promotion of healthy parent-infant interaction, appropriate cognitive and language stimulation, well-baby health care, family support, and center-based infant day care. Physical Health Interventions with Applications to Mental Health High-Quality Prenatal and Perinatal Care Prenatal and perinatal care provide examples of universal preventive interventions directed at the entire population of pregnant women for the protection of the developing fetus and the newborn baby. There is a strong general health promotion and wellness aspect to prenatal care, but such care is also known to prevent prematurity and low birthweight, as well as specific disabilities and disorders in newborns. There is general agreement that all pregnant women should receive early, regular, and comprehensive prenatal care. In Healthy People 2000: National Health Promotion and Disease Prevention Objectives (DHHS, 1991), the U.S. Public Health Service affirmed that ensuring all infants a healthy start in life and enhancing the health of their mothers must be a top priority in the 1990s if we are to ensure the future health of the nation. Despite this consensus, however, there continue to be large numbers of women in the United States who do not receive prenatal care. Teenage mothers, mothers who are members of disadvantaged minorities, and unmarried mothers all tend to receive prenatal care that is late or inadequate, or they receive no prenatal care at all (IOM, 1985). Well-established medical guidelines define the timing and protocol for appropriate prenatal care, but frequently these are not followed for these high-risk groups (IOM, 1985). Lack of prenatal care has important implications for mental disorders. Inadequate or absent prenatal care is the main cause of a mixed group of preventable disorders that appear in low-birthweight babies. In the United States, there are disproportionately high rates of low-birthweight babies in some racial and ethnic groups, particularly among African-Americans (Center for the Study of Social Policy, 1992). Low-birthweight babies constitute about 60 percent of all infant deaths. Those babies that survive often do so with major lifelong disorders, such as mental retardation and cerebral palsy, as well as behavioral, emotional, and learning problems (IOM, 1985). There is also some preliminary limited evidence that pregnancy and birth complications may play a role in later development of schizophrenia (see Chapter 6). Improving prenatal and perinatal care and delivering this care to all pregnant
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Representative terms from entire chapter: