Journal of Pediatric Psychology, Vol. 26, No. 7, 2001, pp. 385-394
© 2001 Society of Pediatric Psychology
Steps Toward a Clinically Relevant Science of Interventions in Pediatric Settings: Introduction to the Special Issue
1 Case Western Reserve University School of Medicine, 2 Ohio State University College of Medicine
All correspondence should be sent to Dennis Drotar, Rainbow Babies & Children's Hospital, Department of Pediatrics, 11100 Euclid Avenue, Cleveland, Ohio 44106-6030. E-mail: dxd3{at}po.cwru.edu .
| Abstract |
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Objective: To describe methods and strategies to advance the science of interventions in pediatric psychology.
Methods: We consider the advantages of various strategies to develop and extend the applications of intervention research in pediatric practice settings.
Results: Strategies are needed to enhance application of empirically supported interventions to pediatric settings, including testing the generalizability of empirically supported interventions in clinical samples, developing interventions based on clinical experience and tested in controlled clinical trials, designing program evaluations in the context of practice settings, and conducting case studies and series. Critical next steps in intervention research include documenting the clinical significance of interventions, conducting multisite research concerning interventions, including interventions conducted in clinical settings, and implementing integrated clinical intervention and research. Training in empirically supported treatments and intervention research and developing policy related to intervention research would also promote a clinically relevant scientific agenda concerning intervention research with pediatric populations.
Conclusions: Pediatric psychologists have the opportunity to develop a clinically relevant science of interventions in pediatric settings by using multiple methods and strategies.
Key words: intervention; treatment; pediatric populations; clinical significance; clinical relevance.
| Introduction |
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The science related to psychological interventions with pediatric populations is now at a crossroads representing the emerging maturity of the field: on the one hand, there is a growing body of scientific information concerning the efficacy of psychological interventions that have been used with a range of pediatric populations. In this regard, the Journal of Pediatric Psychology's (JPP) highly successful series on empirically supported treatments has been an important impetus.
On the other hand, given the focus of this series, it is not surprising
that most of the reviewed studies have focused on the efficacy of
research-based interventions rather than the effectiveness of clinical care as
currently delivered by pediatric psychologists in practice settings.
Consequently, as in other areas of clinical intervention with children
(Kazdin, 2000
;
Weisz, 2000
), there is a
significant gap between the available results from empirically supported
treatments in pediatric psychology and their implementation in practice.
Closing this gap represents an important challenge for the field of pediatric
psychology.
Several critical issues need to be addressed to develop and sustain more widespread application of empirically supported interventions in pediatric psychology and to enhance their clinical relevance. One priority is documentation of the clinical significance of interventions in pediatric settings in ways that address the following question: do interventions improve children's functioning in ways that matter to children and families, referring pediatricians, and other professionals who are consumers of pediatric psychology services?
Another priority concerns demonstration of the generalizability of empirically supported interventions with a broad range of clinical populations. In this regard, significant questions include the following: can interventions shown to be effective with relatively homogeneous populations in the context of research studies be implemented on a widespread basis with more heterogeneous populations? What are the limits or boundary conditions of such generalization? What barriers must be surmounted to ensure that empirically supported interventions reach greater numbers of children and families?
A third priority concerns the development and evaluation of new interventions to address clinically compelling, heterogeneous problems for which empirical data are currently limited (e.g., complex combinations of physical illness and mental health problems, chronic problems with adherence to medical treatment, chronic pain that severely limits functioning, etc.).
This special issue of JPP concerning clinical interventions in pediatric settings considers research that addresses these priorities. We hope that the publications in this issue, which reflect the current state of the art in applied clinical intervention research in pediatric psychology, will stimulate others to meet the considerable challenges of such research and advance the level of scientific knowledge in this field. To facilitate this goal, our introduction to this issue considers the special problems involved in clinical intervention research in practice settings and suggests strategies to address them.
| Challenges to Clinical Application of Empirically Supported Interventions in Pediatric Settings |
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It is not difficult to understand potential reasons for the gap between the research findings concerning empirically supported interventions and their application in pediatric settings. One obstacle to such application is the different professional role demands for researchers and practitioners and contrasting values and incentives for their professional work (Drotar, 1991
In marked contrast to researchers, pediatric psychology practitioners are in the front lines of clinical care. Their responsibilities involve delivering interventions to children referred to them with a wide range of problems. They are pressed for answers to compelling questions from parents (what problem does my child have? what can be done about it now?). Except for those with highly specialized practices, most practitioners encounter extraordinary individual variations in clinical problems and available family and economic resources in children they are called on to treat.
The broad scope of the clinical practice of pediatric psychology poses
significant barriers to the integration of research and practice concerning
treatment efficacy for several reasons: for one, multiple outcomes are
affected by the psychological problems encountered in pediatric populations,
including children's emotional and cognitive development and health, as well
as family outcomes, such as parental mental health and family relationships.
Consequently, clinical interventions should specifically target these critical
dimensions or be sufficiently powerful to generalize across multiple outcome
dimensions (Drotar, 1997
).
More important, interventions delivered in the context of clinical care need to address complex, multifaceted problems that often require highly individualized treatment plans. Such practice constraints limit the immediate application of most standardized or "one size fits all" empirically supported intervention models developed in the context of randomized controlled trials with pediatric populations.
Consequently, most, if not all, of the intervention models developed in controlled trials need to be substantially modified and tailored to be more applicable to practice settings. But herein lies an essential paradox: interventions developed and tested in controlled research and then substantially modified to be implemented in practice may not be valid in the context of practice. Consequently, an alternative approach is to conduct studies of the effectiveness of interventions as they are delivered in clinical settings. But who is to conduct such studies, and how can they be implemented? Researchers may not be interested in generalizing their intervention models to a range of problems and settings. On the other hand, practitioners generally do not have the time or resources to conduct validation studies.
The collaborative context of pediatric psychology services creates another
set of challenges for the development of intervention research and for
clinical application of such findings. Researchers depend on pediatricians,
other professionals, and parents for referrals of patients for their studies.
For this reason, research concerning interventions requires the development of
close collaboration with pediatric and other practitioners in pediatric
settings. However, such collaborations are difficult to develop and sustain
for multiple reasons (Drotar,
1995
), not the least of which includes the formidable pressures of
practice in a managed care environment
(Walders & Drotar, 1999
).
As a result, many practitioners find it difficult, if not impossible, to
participate in research, even research focused on clinical interventions and
consistent with their professional interests.
| Strategies to Bridge the Gap Between the Research and Practice of Interventions |
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For all of the reasons already noted, the wide gap between the results of intervention research and the practice of empirically supported interventions in pediatric psychology threatens to increase over time. What would bridge the gap? What strategies are likely to have the best payoff? Our experience suggests that there is no one ideal strategy to accomplish this aim. Promising strategies are summarized in Table I and include the following: testing the generalizability of empirically supported interventions in clinical samples, implementing evaluations of interventions and programs in practice settings, developing interventions based on clinical experience that are tested in controlled trials and practice in pediatric psychology, using case studies and series to study intervention, enhancing the clinical significance of intervention research, and synthesizing findings concerning intervention effects.
|
Testing the Generalizability of Empirically Supported Interventions
With Clinical Samples
One of the important next steps in treatment and interventionrelated
research is to apply the models and programs demonstrated as effective in
randomized controlled trials to practice settings. At this point, a relatively
large number of interventions in pediatric psychology have been supported by
data. (For some examples, see Holden,
Deichmann, & Levy, 1999
;
McQuaid & Nassau, 1999
;
Mellon & McGrath, 2000
;
Powers, 1999
.) Nevertheless,
few of these interventions have been tested in practice settings with clinical
populations. As one example, McQuaid and Nassau found that relaxation training
was probably efficacious in reducing symptoms related to asthma, especially
for children with emotional triggers. In particular, EMG feedback was
efficacious in reducing frontalis muscle tension for children with asthma.
However, the applicability and effectiveness of these interventions for
children with asthma referred to pediatric psychologists for problems in
illness management, as well as the clinical significance of reductions in
illness-related symptoms related to such interventions, still need to be
established. Similar opportunities for clinical applications are available for
any of the empirically supported treatments described in the JPP
series.
Implementing Evaluations of Programs and Treatments in Practice
Settings
Among others, Weisz (2000
)
has argued for a clinic-based treatment development model for child and
adolescent clinical psychology in which the development and testing of
empirically supported treatments takes place in clinical practice settings.
His cogent recommendation also challenges the field of pediatric psychology.
Evaluation of the interventions and programs delivered in practice settings
has not been a frequently used strategy of pediatric psychology intervention
researchers, with some exceptions (Finney,
Riley, & Cataldo, 1991
).
Multiple methods and approaches will be needed to develop the knowledge base concerning evaluations of clinical interventions conducted in pediatric settings for several important reasons: in some instances, it may be premature to conduct a randomized controlled clinical trial of an intervention. For example, there may not be sufficient empirical evidence concerning an intervention model to warrant the investment of time, energy, and funds in an experimental trial. Consequently, it may be more useful to gather data concerning the feasibility and preliminary results of interventions delivered in practice before refining the intervention model using a controlled study.
In situations where services are already being provided to pediatric
populations, it may not be feasible or ethically defensible to implement a
controlled intervention study. In situations where researchers cannot change
the patterns of service delivery for purposes of their research, program
evaluation provides an alternative method. Program evaluations generally
include a description of the participants in a program, the specific
intervention delivered and evaluation of outcomes, ideally with a detailed
pre- and postevaluation over a suitable follow-up period
(Weiss, 1998
).
A handful of pioneering pediatric psychology researchers has conducted
program evaluations that provide a model for this approach. For example, Olson
et al. (1989
) conducted an
evaluation for a program of inpatient consultation, and Finney et al.
(1991
) have described a model
for assessing the outcomes of children referred for outpatient treatment of
behavioral problems. Recently, Naar-King, Siegel, Smythe, and Simpson
(2000
) have outlined a model
that can be used to evaluate collaborative health care programs for children
with special needs that applies to pediatric settings. This model includes
evaluation of the process components of a program such as the numbers of
visits, utilization of services, accountability or documentation of provided
services, continuity of service, and coordination or the degree to which the
team communicates with other caregivers. The outcome evaluation component
includes parent, staff, and child satisfaction with the services provided,
level of teamwork, medical outcomes (e.g., visits to the emergency room or
inpatient hospitalization), and psychosocial outcomes (e.g., behavioral
adjustment or adherence to medical treatment).
Researchers' contributions to this special issue illustrate the program evaluation approach. Sobel, Roberts, Rayfield, Barnard, and Rapoff (this issue) describe a pediatric psychology clinic that has operated for a number of years, together with information concerning outcomes of the interventions provided. Data indicate that children's behavior improved significantly from pre- to posttreatment and that parents were satisfied with the services and recommendations provided.
Douglas, Kelley, Van Horn, and DeMaso (this issue) describe the role of process evaluation in evaluating the development of a new hospital-based mental health clinic for children facing medical stressors. Their findings support the feasibility and utility of using a process evaluation approach to facilitate the development of clinical services in pediatric psychology settings, as well as to create opportunities for collaboration with medical providers.
Finally, Schuman, Holtz, Peterson, and Rakusan (this issue) evaluated a multicomponent pain management intervention for children with human immunodeficiency virus (HIV) infection who were undergoing routine venipuncture in connection with their treatment with HIV. Multicomponent interventions included preparation, relaxation, distraction, parent involvement, and EMLA anesthetic cream. Children's reports of pain were significantly reduced by the time of the third postintervention procedure. Moreover, child distress and parent anxiety were significantly lower by the time of the second postintervention procedure.
Readers and reviewers should appreciate that program and process
evaluations serve different but nonetheless important functions that contrast
with randomized clinical trials designed to test the efficacy of
interventions. Program and process evaluations are best used to document the
feasibility and acceptability of interventions, characteristics of
participants in interventions, or to describe the impact of an intervention in
changing psychological problems, medical symptoms, and so on from pretreatment
to posttreatment levels. These important goals are best viewed as an initial
step in developing scientific knowledge of interventions, in documenting
potential feasibility of interventions, and enhancing program development in
clinical settings. Owing to different goals and methods, program and process
evaluation cannot be held to the same standards as evaluations of randomized
controlled clinical trials but instead need to be judged by different
standards (Weiss, 1998
). The
characteristics of a very good program evaluation are simply not the same as
those of a controlled trial of intervention. Nevertheless, when evaluating the
findings from program evaluation research, readers need to remain cognizant of
the threats to validity posed by such research, especially if it is
uncontrolled (Campbell & Stanley,
1966
).
Testing Interventions Developed From Clinical Experience in
Controlled Studies
One important but as yet little used strategy in pediatric psychology to
enhance the generalizability of intervention research is to develop specific
interventions, based on extensive clinical experience with a specific
pediatric population, tested in randomized controlled trials. This approach
has the distinct advantage of using data from clinical experiences to
construct a model of intervention, which should have greater clinical
relevance and generalizability than interventions based entirely on previous
research findings. One example of such an approach is Kazak and colleagues'
Surviving Cancer Competently Program
(Kazak et al., 1999
), based on
clinical experience and data concerning the prevalence of posttraumatic stress
in families who experienced childhood cancer. This program documented a need
for preventive interventions to decrease later posttraumatic stress by
reducing distress during treatment (Kazak
et al., 1998
). The intervention model, which integrates behavioral
(Seligman, 1990
) and family
approaches (Steinglass, 1998
)
in group sessions for separate groups of survivors of cancer (mothers,
fathers, siblings), is now being tested in a controlled trial.
Using Case Studies and Series to Study the Impact of
Interventions
One useful strategy to facilitate the application of clinically relevant
interventions in pediatric settings is to use case studies or series, which
have several important advantages. First, the case study gives researchers and
practitioners maximum flexibility to develop interventions with a range of
clinical problems. For this reason, case studies and series can be used to
illustrate the impact of a new intervention or generalizability of an
empirically supported intervention to a new population. Palermo and Scher's
(this issue) case study of a child who was incapacitated by pain provides a
dramatic example of an intervention that focused specifically on improving the
child's functioning. Case studies and series also have the potential advantage
of engaging practitioners who are generally not in a position to conduct
large-scale randomized clinical trials of interventions in research.
On the other hand, publishable case studies are by no means easy to conduct
or prepare because they require collection of baseline data, special
methodologies, or specification of their unique contribution to convince
reviewers of their scientific merit. (See
Drotar, LaGreca, Lemanek, & Kazak,
1995
, for a detailed discussion of guidelines for published case
studies in JPP.) Judging from the small numbers of case studies
published in JPP over the past 5 years, there is a continuing gap
between the potential versus reality of the scientific contribution of case
studies to research on interventions in pediatric psychology.
Evaluating the Clinical Significance of Intervention Research
One of the important topics for future research concerns the demonstration
of the clinical significance of interventions conducted in pediatric settings,
a neglected topic in the field of clinical psychology (see Kazdin,
1999
,
2000
; Kendall, Marrs-Garcia,
Nash & Sheldrick, 1999). Several methods can be used to evaluate the
clinical significance of interventions, including the following
(Kazdin, 2000
): (1) comparison
with normative samples (i.e., demonstrating that at the end of treatment the
scores of treated clinical problems fall now within the range of normative
behavior); (2) comparison with pretreatment samples (i.e., demonstrating that
the score for an individual at the end of treatment has departed substantially
from his or her initial score at the beginning of treatment); (3) use of
psychiatric diagnostic criteria (i.e., demonstrating that individuals no
longer meet diagnostic criteria for disorders or problems for which they were
referred for intervention); (4) subjective evaluation of the impact of
interventions (e.g., evidence that children or parents perceive a significant
change); and (5) evaluation of social impact (e.g., demonstrating that the
intervention has affected functioning in ways that are important to families
and practitioners who make referrals).
Although demonstrations of clinical significance in research on
interventions in pediatric psychology have been limited for the most part,
some researchers have described the clinical significance of interventions in
interesting ways, and others might wish to follow their lead. Some examples of
such research include assessments of social validity of behavioral
interventions (Wysocki et al.,
1997
), costs and benefits of interventions
(Pinto & Hollandsworth,
1989
), and changes in clinically relevant outcomes, including use
of medications (Varni, Gilbert, &
Dietrich, 1981
), hospitalizations
(Olness, 1981
), medical
visits, and school absences (Finney,
Lemanek, Cataldo, Katz, & Fuqua, 1989
).
Another way to enhance the clinical significance of intervention studies is to broaden the range of children who participate to include clinical samples. The majority of interventions that have been empirically supported in pediatric psychology have been conducted on nonreferred populations for whom the clinical significance of the problems encountered were not clearly documented or were unknown. For this reason, documenting the clinical significance of interventions conducted on clinically referred populations using multiple methods (e.g., case reports and series, program evaluation, and controlled trials) would appear to be an important next step.
Synthesizing Findings Concerning Intervention Effects
There is a continuing need for critical synthesis of the known and the
unknown about interventions in pediatric psychology so that this information
can be used to improve methods and models and extend their generalizability
(Drotar, in press
). To address
this need, Plante, Lobato, and Engel (this issue) conducted a systematic
review of studies that described group treatments for pediatric populations,
which have been used in many settings but have not been systematically
evaluated. Their results indicated that a number of group interventions show
scientific promise and underscores the need to implement group treatments in
pediatric populations.
The JPP series on empirically supported treatments has certainly
filled an important need for scholarly synthesis of intervention research.
These reviews should be extended to include methods such as meta-analyses
(Rosenthal, 1991
). A critical
advantage of meta-analysis is the comprehensive analysis of the pattern of
effect sizes as a function of clinically relevant factors, such as sample
characteristics (age, presence or absence of associated problems, such as
compliance problems, type of intervention, etc.) of intervention findings
using a common metric. (See Kibby, Tyc,
& Mulhern, 1998
, for an example of meta-analysis concerning
interventions with children and adolescents with chronic medical illness.)
| Future Directions |
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The implementation of clinically relevant intervention research in pediatric psychology in the ways we have defined it in this special issue will require new approaches. Promising new directions include conducting multisite research concerning interventions conducted in practice, implementing intervention research in the context of clinical programs, implementing integrated clinical intervention and research programs, promoting information exchange and training concerning empirically supported interventions, developing training methods and models for the conduct of intervention research, and working to develop policies based on findings from intervention research.
Implementing Multisite Research Concerning Interventions Conducted in
Practice Settings
One of the more creative but as yet untried (to our knowledge) strategies
of enhancing research in practice in pediatric settings is to conduct
large-scale research on the interventions conducted by practicing pediatric
psychologists. We know little about what intervention modalities are currently
used most frequently by pediatric psychologist practitioners with a range of
populations.
Our medical colleagues in pediatrics and psychiatry have a head start in
conducting large-scale descriptive research concerning practice patterns. Such
work can inform the development of practice-based research in pediatric
psychology. For example, there is the Child Behavior Study, conducted with a
national network of pediatric practices, as well as the Pediatric Research in
Office Settings (PROS) network (Kelleher,
McInerny, Gardner, Childs, & Wasserman, 2000
). A second
network, the American Psychiatric Practice Research Network, is conducting
research on the patterns and combinations of treatment provided for specific
mental disorders and comorbid conditions, as well as the clinical
decision-making process (West,
2000
). Such practice-based research may help to identify
discrepancies between treatments and empirically supported treatments that
need to be addressed in research, training, and continuing education.
Moreover, pediatric psychologists have a track record of collaboration in
multisite research that could facilitate the implementation of such studies
(Armstrong & Drotar,
2000
).
Implementing Integrated Clinical Intervention and Research
Programs
Optimal integration of intervention research with clinical care requires a
long-term commitment to a research program that includes multiple methods
including descriptive and experimental research, ideally in a practice
setting. Few have been able to achieve this difficult standard. Nonetheless,
the field of pediatric psychology does have models to draw on. These include
Kazak's integrated research and practice psychosocial services program in the
Division of Oncology at the Children's Hospital of Philadelphia
(Kazak, in press
;
Kazak & Meadows, 2000
);
Blount, Bunke, and Zaff's
(2000a
,
2000b
) integration of basic
research, treatment research, and clinical practice at the University of
Georgia; and Powers and colleagues' comprehensive evaluation of interventions
(medication and behavioral) of children and adolescents with headaches at
Children's Hospital Medical Center, Cincinnati
(deGrauw, Hershey, Powers, & Bentti,
1999
; Hershey, Powers, Bentti,
& deGrauw, 2000
; Hershey,
Powers, Bentti, LeCates, & deGrauw, in press
;
Powers et al., in press
).
Readers are referred to these authors' descriptions of their approaches and
suggestions for strategies to conduct such work.
Promoting Information Exchange and Training Concerning Empirically
Supported Interventions
As new interventions are developed, tested, and supported by research,
practitioners and students need to know about them and consider their
potential relevance to practice. Moreover, practitioners who develop new ideas
about potentially effective interventions forged in the experiences of
clinical practice need to communicate with researchers to test the validity of
their ideas (Weisz, 2000
).
Empirically supported behavioral interventions do not necessarily make
their way into practice readily. (See
Houts, 2000
, for a discussion
related to behavioral versus pharmacological treatments for enuresis.) For
this reason, pediatric psychology researchers and practitioners have an
opportunity, if not a responsibility, to make empirically supported treatments
more available to their colleagues through presentations and workshops,
publications, and expert consultation. In this regard, Henggeler and
colleagues' continuing work (Henggeler
& Randall, 2000
) to implement multisystemic treatment (MST) in
multiple sites through formal training and consultation in local communities
is an example for pediatric psychologists to emulate.
Developing Training Methods and Models for the Conduct of
Intervention Research
Intervention research raises many formidable methodological and pragmatic
problems (e.g., methods that are appropriate for analysis of prospective data,
implementing methods to reduce subject attrition, ethical issues, etc.). These
methods require specialized didactic training and experiences with a range of
methods (e.g., training in single case study designs, program evaluation
research, and methods related to randomized controlled trials of intervention)
that may not be consistently emphasized in graduate training.
Owing to important reality constraints such as the need to finish a
graduate training program within a reasonable time frame, many students lack
opportunities to conduct intervention research for their master's and
dissertation research. Nevertheless, graduate training programs can facilitate
the training of students in intervention research in pediatric psychology by
providing hands-on opportunities for students to participate in ongoing
research studies that focus on interventions. For example, the pediatric
psychology research training program at Case Western Reserve University has
given students hands-on experience in research on such interventions as
screening of economically disadvantaged mothers for depression in a primary
care pediatric clinic (Needlman et al.,
1999
), a pediatric psychology service designed to assess
behavioral problems seen by primary care practitioners (Riekert, Stancin,
Palermo, & Drotar, 1998), and a randomized controlled trial of the
efficacy of a problem-solving intervention to reduce asthma-related morbidity
in children and adolescents (Walders,
2001
).
Critical opportunities for postdoctoral training in intervention research in pediatric psychology need to be developed. Such programs can provide trainees with opportunities to design and implement intervention research, learn about the methodological issues in randomized controlled trials, ethical issues in intervention research, and so on under the supervision of experienced mentors.
Promoting Policies Based on Findings From Intervention Research
The clinical relevance of intervention research would also be enhanced by
promoting policies based on findings from such research
(Houts, 2000
). Perhaps more
researchers would develop empirically supported interventions and more
practitioners would learn to implement them if these interventions were
supported by policies that govern reimbursement of clinical care. The forces
that shape reimbursement are complex and are certainly beyond the scope of
this discussion (Walders & Drotar,
1999
). Nevertheless, there is a gap between the interventions
reimbursed by insurance companies and sought after by consumers versus those
interventions supported by empirical data. Consequently, there is a need for
pediatric psychologists in educating consumers, pediatric practitioners, and
policy makers, including managed care companies, concerning those
interventions shown to be effective in improving clinically relevant outcomes
and the implications for service delivery.
There is a considerable agenda for future research to facilitate the
development of a clinically relevant science of intervention in pediatric
settings. Moreover, pediatric psychologists are not alone in facing the
daunting task of implementing such an agenda. For example, the Committee on
Science and Practice for Division 12 has recently made a series of important
recommendations to enhance evidence-based practice and training in the field
of clinical psychology that will be of interest to pediatric psychologists
(Weisz, Hawley, Pilkonis, Woody, &
Follette, 2000
). Clearly, there is a long way to go in developing
a clinically relevant science of interventions in pediatric settings. As a
consequence, considerable opportunities exist for pediatric psychologists to
advance the field. The contributors to this special issue have taken important
steps in meeting some of the challenges of clinically relevant intervention
research, and we applaud their efforts.
| Acknowledgments |
|---|
Susan Wood's excellent work in processing this manuscript is gratefully acknowledged.
Received December 20, 2000; accepted February 1, 2001
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