Editorial: Assessing and Enhancing Clinical Significance/Social Validity of Intervention Research in Pediatric Psychology

Abstract

The purpose of this editorial is to renew the call for assessing and documenting clinical significance/social validity in our intervention research. Clinical significance/social validity needs to be documented at three levels: (1) the goals of our intervention studies are relevant to interested parties, such as children, parents, referral sources, and third party payers; (2) the intervention procedures are acceptable to interested parties and are therefore more likely to be adopted if effective; and (3) the effects of our interventions are satisfactory to consumers and meet some standard of achieving clinically significant effects. This editorial describes methods for assessing clinical significance/ social validity at all three levels. A statistically significant treatment effect gives us confidence that an effect is not due to chance. However, a statistically significant effect does not inform us about the size, importance, or clinical significance of the effect. Even ‘‘effect sizes’’ (using Cohen’s convention of r1⁄4 .10 as small, r1⁄4 .30 as medium, and r1⁄4 .50 as large; Cohen, 1988), do not determine if the threshold for clinical significance has been reached. For example, the effect size for low-dose aspirin used to prevent first heart attacks was r1⁄4 .02, which is less than a ‘‘small’’ effect size according to Cohen. However in that study, the sample size was large (22,071) and the risk reduction was 44% (p .00001). Consequently, the trial was prematurely stopped due to the obvious benefits of low-dose aspirin (Steering Committee of the Physicians’ Health Study Research Group, 1988). There have been previous admonitions published in this journal about the need to document clinical significance/social validity in intervention research in pediatric psychology (Drotar, 1997, 2008, 2009; Drotar & Lemanek, 2001). The purpose of this editorial is to renew that call for assessing and documenting clinical significance/social validity in our intervention research. My objectives are to (1) define clinical significance and social validity, and (2) describe ways to assess clinical significance and social validity using examples from the literature.