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 journalArticle

17 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)439-450
Number of pages12
JournalJournal of Consulting and Clinical Psychology
Volume77
Issue number3
DOIs
StatePublished - Jun 2009

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Treatment-Resistant Depressive Disorder
Randomized Controlled Trials
Clinical Trials
Cognitive Therapy
Clinical Protocols
Outcome Assessment (Health Care)

Keywords

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

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Sources of Site Differences in the Efficacy of a Multisite Clinical Trial : The Treatment of SSRI-Resistant Depression in Adolescents. / Spirito, Anthony; Abebe, Kaleab Z.; Iyengar, Satish; Brent, David; Vitiello, Benedetto; Clarke, Gregory; Wagner, Karen Dineen; Asarnow, Joan; Emslie, Graham; Keller, Martin.

In: Journal of Consulting and Clinical Psychology, Vol. 77, No. 3, 06.2009, p. 439-450.

Research output: Contribution to journalArticle

Spirito, Anthony ; Abebe, Kaleab Z. ; Iyengar, Satish ; Brent, David ; Vitiello, Benedetto ; Clarke, Gregory ; Wagner, Karen Dineen ; Asarnow, Joan ; Emslie, Graham ; Keller, Martin. / Sources of Site Differences in the Efficacy of a Multisite Clinical Trial : The Treatment of SSRI-Resistant Depression in Adolescents. In: Journal of Consulting and Clinical Psychology. 2009 ; Vol. 77, No. 3. pp. 439-450.
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