Randomized Controlled Trials: Design and Implementation for Community-Based Psychosocial Interventions

224 Pages·2009·3.037 MB·English

by  Phyllis Solomon, Mary M. Cavanaugh, Jeffrey Draine

Randomized Controlled Trials
P O C K E T G U I D E S T O
SOCIAL WORK RESEARCH METHODS
Series Editor
Tony Tripodi, DSW
Professor Emeritus, Ohio State University
Determining Sample Size
Balancing Power, Precision, and Practicality
Patrick Dattalo
Preparing Research Articles
Bruce A. Thyer
Systematic Reviews and Meta-Analysis
Julia H. Littell, Jacqueline Corcoran, and Vijayan Pillai
Historical Research
Elizabeth Ann Danto
Confi rmatory Factor Analysis
Donna Harrington
Randomized Controlled Trials
Design and Implementation for
Community-Based Psychosocial Interventions
Phyllis Solomon, Mary M. Cavanaugh, and Jeffrey Draine
Needs Assessment
David Royse, Michele Staton-Tindall, Karen Badger,
and J. Matthew Webster
PHYLLIS SOLOMON
MARY M. CAVANAUGH
JEFFREY DRAINE
Randomized
Controlled
Trials
Design and Implementation for
Community-Based Psychosocial
Interventions
1
2009
1
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Copyright © 2009 by Oxford University Press, Inc.
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Library of Congress Cataloging-in-Publication Data
Solomon, Phyllis L.
Randomized controlled trials : design and implementation for
community-based psychosocial interventions / Phyllis Solomon, Mary M.
Cavanaugh, and Jeffrey Draine.
p. cm.
Includes bibliographical references and index.
ISBN 978-0-19-533319-0
1.Social service—Research—Methodology. 2. Evidence-based social work.
I. Cavanaugh, Mary M. II. Draine, Jeffrey. III. Title.
HV11.S5946 2009
361.3'20724—dc22
2008029903
1 3 5 7 9 8 6 4 2
Printed in the United States of America
on acid-free paper
Acknowledgments
W e would like to thank Mallory Jensen for her wonderful competence,
responsiveness, and kind understanding. In addition, we want to acknowl-
edge Leslie Alexander and Francis Barchi for their helpful comments on
previous drafts of the manuscript. We express our gratitude to the review-
ers for their thoughtful comments that served to strengthen the fi nal
manuscript. We also want to thank the agency administrators and pro-
viders who, in their pursuit of more effective interventions for the clients
they so selfl essly serve, allowed “outsiders” in to conduct our research.
But most importantly, we thank the participants of our research inter-
ventions. Without these partners and collaborators sharing our belief in
the value of sound research and its connection to more effective services,
the many RCTs in which we have been involved would not have been
a reality. We are forever indebted to far too many to name each indi-
vidually, but without their support and participation we would not have
learned the challenges and pitfalls of these deceptively simple designs and
therefore, this book would not have been possible.
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Contents
Acknowledgments v
1 Introduction 3
2 Ethical Considerations of Randomized Controlled Trials 19
3 Planning the Randomized Controlled Trial 45
4 Developing Conceptual Foundations for Randomized
Controlled Trials 80
5 Designing the Randomized Controlled Trial 96
6 Implementing the Randomized Controlled Trial 138
7 Generalizing Randomized Controlled Trial Outcomes
to Community Practice Settings 170
Glossary 187
References 195
Index 209
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1
Introduction
The primary objection raised about a randomized controlled trial
(RCT) is related to its central feature: the randomness of the decision
regarding an individual’s treatment regimen. To some, it seems unethical
to base such an important decision on mere chance. In order to examine
this objection, it may prove useful to begin with a careful examination
into the randomness and rationality in our health and social service sys-
tems as they typically operate. Adults and children experiencing acute
challenges such as abuse, health crises, mental illness, substance abuse,
and incarceration, to name a few, are sorted into varying categories, case-
loads, service systems, and need levels, and placed onto wait lists every
day throughout a wide variety of settings. How rational are these sorting
mechanisms? How often is this sorting accomplished using validated pro-
cedures or reliable assessments? How often is this sorting driven by the
relatively random availability of an open placement or funding streams?
Quite often, the services individuals receive and/or are eligible for are
dependent on layers of random decisions far beyond the control of indi-
vidual practitioners, case managers, or program directors.
Moving the above discussion a step further, it would be useful to
inquire to what extent these sorting mechanisms are n ot random, and
rather are based on biases and choices that are more unfair than chance?
3