Premium
Design of Control‐Group Conditions in Clinical Trials of Behavioral Interventions
Author(s) -
Lindquist Ruth,
Wyman Jean F.,
Talley Kristine M.C.,
Findorff Mary J.,
Gross Cynthia R.
Publication year - 2007
Publication title -
journal of nursing scholarship
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.009
H-Index - 80
eISSN - 1547-5069
pISSN - 1527-6546
DOI - 10.1111/j.1547-5069.2007.00171.x
Subject(s) - psychological intervention , clinical study design , control (management) , clinical trial , intervention (counseling) , research design , strengths and weaknesses , medicine , behavior change , applied psychology , computer science , risk analysis (engineering) , psychology , nursing , social psychology , artificial intelligence , social science , pathology , sociology
Purpose: To review considerations in the design of placebo (attention) control conditions for community‐based clinical trials of health behavior change interventions and to provide practical strategies for the design of control conditions.Organizing Constructs: A well‐designed control condition is an essential component of a clinical trial to foster the unambiguous interpretation of study findings.Methods: Pitfalls in the design of control conditions in clinical trials of behavioral interventions are identified and strategies to address them are offered. Types of control conditions that have been used in fall prevention trials are described, along with their strengths and weaknesses. The control condition used in the recent fall evaluation and prevention program (FEPP) was designed to overcome limitations of previous trial designs; it is provided to illustrate how to apply specific design principles.Conclusions: Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.