Choosing a control group in effectiveness trials of behavioral drug abuse treatments

Maryhaven Research Institute, Maryhaven, Columbus, OH 43207, USA.
Journal of substance abuse treatment (Impact Factor: 2.9). 07/2009; 37(4):388-97. DOI: 10.1016/j.jsat.2009.05.004
Source: PubMed


Effectiveness trials are an important step in the scientific process of developing and evaluating behavioral treatments. The focus on effectiveness research presents a different set of requirements on the research design when compared with efficacy studies. The choice of a control condition has many implications for a clinical trial's internal and external validity. The purpose of this article was to provide a discussion of the issues involved in choosing a control group for effectiveness trials of behavioral interventions in substance abuse treatment. The authors provide a description of four trial designs and a discussion of the advantages and disadvantages of each.

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Available from: Daniel J Feaster
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    • "Note that Design 2 in the original conceptualization (Brigham, Feaster, Wakim, and Dempsey, 2009) has been subdivided into Design 2a and Design 2b, depending on whether the new intervention is an add-on to TAU, or substitutes for some existing component of TAU. "
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    ABSTRACT: Multisite effectiveness trials such as those carried out in the National Drug Abuse Treatment Clinical Trials Network (CTN) are a critical step in the development and dissemination of evidence-based treatments because they address how such treatments perform in real-world clinical settings. As Brigham et al. summarized in a recent article (G. S. Brigham, D. J. Feaster, P. G. Wakim, & C. L. Dempsey C. L., 2009), several possible experimental designs may be chosen for such effectiveness trials. These include (a) a new treatment intervention (Tx) is compared to an existing mode of community based treatment as usual (TAU): Tx versus TAU; (b) a new intervention is added to TAU and compared to TAU alone: Tx + TAU versus TAU; or (c) a new intervention is added to TAU and compared to a control condition added to TAU: Tx + TAU versus control + TAU. Each of these designs addresses a different question and has different potential strengths and weaknesses. As of December 2009, the primary outcome paper had been published for 16 of the multisite randomized clinical trials conducted in the CTN, testing various treatments for drug abuse, HIV risk behavior, or related problems. This paper systematically examines, for each of the completed trials, the experimental design type chosen and its original rationale, the main findings of the trial, and the strengths and weaknesses of the design in hindsight. Based on this review, recommendations are generated to inform the design of future effectiveness trials on treatments for substance abuse, HIV risk, and other behavioral health problems.
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    ABSTRACT: To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.
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