STRATEGIES FOR MAXIMIZING THE CLINICAL SIGNIFICANCE OF INTERVENTION PROGRAMS
A clear goal of behavioral intervention research is to develop and implement intervention programs that are clinically significant and effect a change that is meaningful to an individual and society. One strategy for achieving this goal is to design interventions that place individuals “at risk” and target factors that are amenable to change. For example, the Resources for Enhancing Alzheimer’s Caregiver Health II (REACH II) intervention (Chapters 2, 4 and 14) targeted five areas that place caregivers who are at risk (e.g., care recipient target behaviors, lack of social support). Although the cognitive status of the person with dementia could not be changed, family caregivers could be instructed in concrete strategies for managing behavior problems, one of the most challenging aspects of caregiving. Also, in REACH II, caregivers in most need were targeted in the intervention. This is not to suggest that studies should “stack the deck” by including only individuals who exhibit extreme levels of dysfunction. Rather, it suggests that intervention programs are more likely to be successful if they target populations who are most in need of the intervention.
Intervention programs are also more likely to achieve clinically significant outcomes if they are congruent with the beliefs, attitudes, values, and needs of target populations. Thus, it is important to conduct a needs assessment prior to the development of an intervention program to obtain information on the needs, goals, and preferences of relevant populations (e.g., caregivers, family members, social service agencies). This can be accomplished through techniques such as focus groups, interviews, or questionnaires. As noted earlier in the chapter, evaluations of social validity should occur at different points during the intervention process—at the beginning, during the course of treatment, or at follow-up. Using community-based participatory approaches and including a community advisory board as part of the intervention team (see Chapter 10) are effective strategies to help achieve these goals.
It is also important to choose measures of clinical significance that are relevant and sensitive to treatment-related goals (Chapter 14). Some measures, such as measures of social impact, may not be sensitive to detect change that results from treatment effects. This issue is further complicated when multiple measures of clinical significance are employed—some measures may change and others may not, or some may change in the reverse direction. This makes it difficult to evaluate the overall impact of the treatment program and determine if clinically significant outcomes have been achieved. A criterion needs to be established for defining clinical significance such as a small improvement on multiple outcomes, a large improvement on a few outcomes, or meeting the absolute standard on a few key outcomes. The criterion chosen will vary with the goals of the program and the stakeholders invested in program outcomes. For example, in caregiver intervention research, the stakeholders are likely to include health care providers, insurers, payers, care recipients, other family members, and, of course, the caregiver. For the caregiver, a meaningful effect may be a reduction in burden and increase in caregiving skills; for other family members, an important outcome may be the physical health of the caregiver; whereas for health care providers, insurers, and payers, cost-effectiveness may be the most important outcome. It is important to be aware of the concerns of the stakeholders during the design and implementation of an intervention program.