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date: 12 May 2021

Abstract and Keywords

This chapter describes methodological and design considerations central to the scientific evaluation of clinical treatment methods via randomized clinical trials (RCTs). Matters of design, procedure, measurement, data analysis, and reporting are each considered in turn. Specifically, the authors examine different types of controlled comparisons, random assignment, the evaluation of treatment response across time, participant selection, study setting, properly defining and checking the integrity of the independent variable (i.e., treatment condition), dealing with participant attrition and missing data, evaluating clinical significance and mechanisms of change, and consolidated standards for communicating study findings to the scientific community. After addressing considerations related to the design and implementation of the traditional RCT, the authors turn their attention to important extensions and variations of the RCT. These treatment study designs include equivalency designs, sequenced treatment designs, prescriptive designs, adaptive designs, and preferential treatment designs. Examples from the recent clinical psychology literature are provided, and guidelines are suggested for conducting treatment evaluations that maximize both scientific rigor and clinical relevance.

Keywords: Randomized clinical trial, RCT, normative comparisons, random assignment, treatment integrity, equivalency designs, sequenced treatment designs

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