Sources of Site Differences in the Efficacy of a Multisite Clinical Trial: The Treatment of SSRI-Resistant Depression in Adolescents

Anthony Spirito; Kaleab Z. Abebe; Satish Iyengar; David Brent; Benedetto Vitiello; Gregory Clarke; Karen Dineen Wagner; Joan Asarnow; Graham Emslie; Martin Keller

doi:10.1037/a0014834

Sources of Site Differences in the Efficacy of a Multisite Clinical Trial: The Treatment of SSRI-Resistant Depression in Adolescents

Anthony Spirito, Kaleab Z. Abebe, Satish Iyengar, David Brent, Benedetto Vitiello, Gregory Clarke, Karen Dineen Wagner, Joan Asarnow, Graham Emslie, Martin Keller

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

Abstract

Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a combined medication plus cognitive-behavioral therapy (CBT) condition. Two potential primary causes of site differences in MRCT outcomes were examined in this article: sampling factors, particularly clinical characteristics of participants, and treatment protocol factors, particularly fidelity. The authors found that differences in the clinical characteristics of participants at baseline across site and within site/across conditions were the most salient explanations for site differences and differences within sites across conditions in outcome. Study findings are discussed with respect to the overall study outcomes in TORDIA as well as MRCTs in general.

Original language	English (US)
Pages (from-to)	439-450
Number of pages	12
Journal	Journal of Consulting and Clinical Psychology
Volume	77
Issue number	3
DOIs	https://doi.org/10.1037/a0014834
State	Published - Jun 2009

Keywords

The Treatment of SSRI-Resistant Depression in Adolescents study
multisite clinical trials
protocol fidelity
sampling factors
site differences

ASJC Scopus subject areas

Clinical Psychology
Psychiatry and Mental health

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10.1037/a0014834

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abstract = "Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a combined medication plus cognitive-behavioral therapy (CBT) condition. Two potential primary causes of site differences in MRCT outcomes were examined in this article: sampling factors, particularly clinical characteristics of participants, and treatment protocol factors, particularly fidelity. The authors found that differences in the clinical characteristics of participants at baseline across site and within site/across conditions were the most salient explanations for site differences and differences within sites across conditions in outcome. Study findings are discussed with respect to the overall study outcomes in TORDIA as well as MRCTs in general.",

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AU - Brent, David

AU - Vitiello, Benedetto

AU - Clarke, Gregory

AU - Wagner, Karen Dineen

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AU - Emslie, Graham

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Sources of Site Differences in the Efficacy of a Multisite Clinical Trial: The Treatment of SSRI-Resistant Depression in Adolescents

Abstract

Keywords

ASJC Scopus subject areas

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