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Randomized Controlled TrialsDesign and Implementation for Community-Based Psychosocial Interventions$
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Phyllis Solomon, Mary M. Cavanaugh, and Jeffrey Draine

Print publication date: 2009

Print ISBN-13: 9780195333190

Published to Oxford Scholarship Online: May 2009

DOI: 10.1093/acprof:oso/9780195333190.001.0001

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Planning the Randomized Controlled Trial

Planning the Randomized Controlled Trial

Chapter:
(p.45) 3 Planning the Randomized Controlled Trial
Source:
Randomized Controlled Trials
Author(s):

Phyllis Solomon

Mary M. Cavanaugh

Jeffrey Draine

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195333190.003.0003

Chapter 3 discusses the requisite research necessary for designing and conducting a full-scale RCT. Preliminary efforts include assessing and negotiating within possible settings, assessing the likelihood of agency/provider cooperation and level of engagement, gauging the capability of providers in executing the interventions, determining the availability of potential study participants, and tracking the flow of participants in and out of a preliminary (pilot) research study. Other topics include: developing recruitment procedures and ways to plan for the engagement and retention of study participants, with a particular emphasis on culturally-competent recruitment. Consideration is given to the identification, modification, and development of intervention manuals, workbooks, and educational curriculum as well as methods for fidelity assessment. Particular attention is focused on planning for the design of the RCT, as well as on the importance of ensuring the feasibility of the RCT through essential pilot work and pipeline assessment.

Keywords:   intervention manuals, fidelity assessment, pilot studies, pipeline assessment, culturally-competent recruitment

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