Journal of Pediatric Psychology, Vol. 27, No. 2, 2002, pp. 167-176
© 2002 Society of Pediatric Psychology
Enhancing Reviews of Psychological Treatments With Pediatric Populations: Thoughts on Next Steps
Case Western Reserve University School of Medicine
All correspondence should be sent to Dennis Drotar, Rainbow Babies and Children's Hospital, Department of Pediatrics, 11100 Euclid Avenue, Cleveland, Ohio 44106-6038. E-mail: dxd3{at}po.cwru.edu .
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Abstract |
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 Top Abstract IntroductionHistory of Reviews of...Limitations of the Chambless...RecommendationsCaveats and Final...References |
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Objective: To critique the approach used by the Journal of Pediatric Psychology for reviews of empirical support for psychological treatments and provide recommendations to enhance the scientific review of interventions.
Methods: Application of the Chambless et al.
(1996
,
1998) criteria to select and
describe empirically supported treatments was evaluated from the standpoint of
method, theory, and clinical significance.
Results: While reviews of treatments based on the Chambless
et al. (1996,
1998) criteria have provided
valuable information, they are limited by reliance on statistical significance
rather than effect sizes and also need to consider systematically the
theoretical and clinical significance of intervention findings.
Conclusions: Reviews of psychological treatments conducted with pediatric populations would be enhanced by inclusion of information concerning effect sizes, theory specification, and clinical significance. In addition, broadening the focus of initial reviews to include meta-analyses, clinical significance, and theory-guided interventions would enhance the scientific knowledge base of psychological interventions with pediatric populations.
Key words: empirically supported treatments; Chambless criteria; psychological interventions; review.
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Introduction |
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TopAbstractIntroductionHistory of Reviews of...Limitations of the Chambless...RecommendationsCaveats and Final...References |
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In recent years, pediatric psychology researchers have underscored the central importance of developing a scientific knowledge base concerning psychological interventions with pediatric populations, especially for interventions that can be used in practice (Drotar, 1997
;
Kazak, 1998). To facilitate
the development of empirically supported interventions and, in particular, to
identify those that have been supported by scientific evidence, the
Journal of Pediatric Psychology (JPP) has initiated a series of
reviews to summarize the results of interventions with pediatric populations
(Kazak, 1998) for the past
several years (e.g., Holden, Deichman, & Levy, 1999;
Janicke & Finney, 1999;
McGrath, Mellon, & Murphy,
2000; McQuaid & Nassau,
1999; Mellon & McGrath,
2000; Powers,
1999; Walco, Sterling, Conte,
& Engel, 1999). Based on the application of the Chambless et
al. (1996,
1998) criteria that specify the
evidence and methods to identify empirically supported interventions,
publications in this series have advanced the science of psychological
interventions with pediatric populations in several important respects. They
have helped to sensitize the readership of JPP to the importance of
empirically supported interventions with pediatric populations, identified
interventions that have been supported by data, underscored methodological
limitations of intervention studies, and suggested new research
directions. Yet, despite these advances, the approach that has guided the reviews of empirically supported intervention adopted by JPP has important but heretofore unrecognized limitations as a strategy to advance the science of psychological interventions, especially the generalizability of intervention findings. Some of these limitations reflect the state of the art in research concerning interventions in the field of pediatric psychology. Others relate to policy and procedures concerning the reviews of empirically supported treatments in JPP. Written primarily to improve the reviews of empirically supported treatments, this critique also contains information of interest to the producers of such research.
This critique describes a central methodological problem: reliance on an approach that identifies and summarizes findings from interventions on the basis of statistical significance rather than effect sizes. A second problem is the failure to consider the theoretical significance of interventions in the approach to the reviews. A third, more pragmatic limitation is that published summaries have not considered critical questions related to the clinical significance of interventions. This commentary describes the implications of each of these limitations and offers recommendations to enhance the reviews of interventions with pediatric populations.
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History of Reviews of Empirically Validated Therapies in Clinical and Pediatric Psychology |
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TopAbstractIntroductionHistory of Reviews of...Limitations of the Chambless...RecommendationsCaveats and Final...References |
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In 1996, the Division 12 Task Force on Promotion and Dissemination of Psychological Procedures developed criteria for empirically validated therapies and examples of evidence-based treatments that met these criteria (Chambless et al., 1996
). The
primary criteria used to classify empirically validated treatments into two
major categories, well-established or probably efficacious, include the
demonstration of statistical significance either in group designs or single
case experiments, the development of treatment manuals, clear specification of
client samples, and the demonstration of effects by at least two different
investigators or investigatory teams (Chambless et al.,
1996,
1998). Based on application of
these criteria, in 1999 JPP published the first of a continuing
series of reviews of "treatments that work," or empirically
supported interventions in pediatric psychology. This series was initiated to
stimulate and improve research concerning psychological treatments, to help
guide selection of intervention strategies in practice, and to promote an
interactive dialogue among scientists concerning intervention research
(Kazak, 1998). Although the
series has provided structure and consistency in the reviews of
treatment-related research and facilitated the publication of high quality
reviews of interventions and commentaries, it also has limitations. |
Limitations of the Chambless et al. (1996-1998) Criteria in Evaluating Treatments |
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TopAbstractIntroductionHistory of Reviews of...Limitations of the Chambless...RecommendationsCaveats and Final...References |
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Methodological Limitations
The most significant methodological problem in the Chambless et al. (1996
,
1998) criteria is the use of
descriptive (Kazdin, 2000) or
vote-counting procedure (Glass, McGraw, & Smith, 1981;
Light & Pillemer, 1984)
that relies heavily on the demonstration of statistical significance to select
efficacious interventions and report the findings in the review. The fact that
effect sizes of intervention findings were not described or considered in
these reviews has several important limitations
(Glass et al., 1981;
Rosenthal, 1991). Larger
samples typically produce greater statistically significant findings than
small samples do, but this does not necessarily mean that such effects are
more powerful or clinically significant. Very large samples have an abundance
of power and can demonstrate statistically significant, albeit clinically
trivial effects (Rosenthal,
1991). In general, treatments with larger effect sizes have a
greater chance of affecting children in ways that make a meaningful difference
to parents, teachers, medical care providers, and the children themselves
(McCartney & Rosenthal,
2000). One of the most important problems with the current
approach to reviews of treatment is that conclusions based on the Chambless et
al. (1996,
1998) criteria contain
insufficient information and can be misleading, because readers cannot easily
gauge the strength of intervention effects based on the information contained
in reviews.
The absence of effect sizes in reviews of treatments also makes it
impossible to compare effect sizes across different studies. In areas of
research in which empirical support for certain types of interventions has
been established, the key scientific questions often shift to documenting the
specific characteristics of interventions, methods, or samples that result in
the most powerful interventions. Comparison of effect sizes across different
studies allows readers to judge the strength of findings across different
interventions, sample characteristics, methods, or outcomes by using the
common metric of effect size (Weiss, Weiss, Alecke, & Klotz, 1987). In the
absence of such information, precise estimates of factors that influence the
power or consistency of intervention effects across different studies cannot
be made (Glass et al., 1981).
The resulting lack of precision poses a special problem for areas of pediatric
psychology research where relatively large numbers of psychological
intervention studies have been conducted, such as with diabetes or asthma
(McQuaid & Nassau, 1999).
In such areas, information concerning effect sizes is necessary to recommend
refinements in interventions to improve the strength and clinical significance
of the effects.
Limited Attention to Clinical Relevance and Significance
Though identification of clinically significant interventions was never the
primary goal of the JPP reviews, the hope was that the data generated
from such reviews would eventually guide selection of intervention strategies
in practice settings (Kazak,
1998). In fact, information contained in the reviews does allow
readers to identify broad categories of interventions identified as
empirically supported (e.g., behavioral interventions to improve the
disease-related symptoms of children with asthma or diabetes;
McQuaid & Nassau, 1999; or
the role of the urine alarm in treatment of enuresis;
Mellon & McGrath,
2000).
On the other hand, while findings based on the recent reviews of
interventions published in JPP have given scientists and
practitioners new information, they do not translate directly into helping
practitioners select and implement interventions in practice settings, as was
intended. One problem is that statistical significance does not translate into
clinical significance (Kazdin,
2000; Kendall, Marrs-Garcia,
Nath, & Sheldrick, 1999), and clinical significance of effects
is not addressed in the reviews.
The complex documentation of clinical significance can be done in a number
of ways (see Jacobson, Roberts, Berns,
& McGlinchey, 1999;
Kazdin, 1999;
Kendall, Marrs-Garcia, Nath, Sheldrick,
1999). For example, Kendall et al.
(1999) have described the
importance of documenting whether an intervention returned once extreme or
abnormal cases to within normative ranges on key dependent measures. These
authors advocate complementing traditional statistical analysis with
equivalency testing to test the hypothesis that two groups are equivalent
within a given range of scores (Kendall et
al., 1999).
Kazdin (1999,
2000) has also described the
importance of other methods of documenting clinical significance: (1)
comparison with pretreatment samples (i.e., demonstration that the score for
an individual at the end of treatment has departed substantially from the
score for an individual at the beginning of treatment); (2) use of psychiatric
diagnostic criteria (i.e., demonstrating that individuals no longer meet
diagnostic criteria for disorder or problem for which they were referred for
treatment); (3) inclusion of subjective evaluations of the impact of
intervention (i.e., evidence that others interact with the child or the child
himself or herself perceives a change that makes a clear difference in
perceived functioning); and (4) social impact (i.e., demonstrating that
treatment has affected the child's functioning in ways that are important to
society, families, or those who value referrals for intervention).
In fact, some of the empirically supported treatments reviewed in
JPP have demonstrated effects on functional outcomes relevant to
practitioners and parents. These include Finney, Lemanek, Cataldo, Katz, and
Fuqua's (1989) demonstration
that brief targeted therapy for recurrent abdominal pain not only relieved
children's pain but reduced school absences and medical visits; Olness's
(1981) finding that imagery
and self-hypnosis reduced pain frequency as well as the number of medications
required to manage pain in a child with cancer; and Varni, Gilbert and
Dietrich's (1987) demonstration that progressive muscle relaxation, meditative
breathing, and guided imagery lessened pain with reduced medications and
hospitalizations, and increased activity for a child with hemophilia. However,
for the most part, treatment-related studies contained in JPP's
reviews did not include information concerning clinical significance, even
though some of these studies included clinically relevant outcome measures.
For example, a number of the studies considered by McQuaid and Nassau's
(1999) review of interventions
in asthma and diabetes included measures of physiologic health status, such as
pulmonary functioning in asthma or control of diabetes as measured by the
hemoglobin AIC. To enhance the clinical significance of findings, it would
have been useful for investigators to describe and analyze the degree of
change in such measures as a function of treatment and to document whether
these measures had improved to levels of adequate or more optimal health
status.
A second problem that relates to the question of clinical significance is
that the children who have participated in many of the intervention studies
described in reviews JPP published are not necessarily the same
children seen by practicing pediatric psychologists. As has been the case for
psychotherapy research with children
(Kazdin, 2000), research
participants in controlled intervention studies generally have less severe, as
well as more homogeneous problems than those who are generally seen by
practitioners in pediatric settings. Moreover, many of the participants in
preventive psychological interventions conducted and evaluated for some
populations (e.g., children with chronic health conditions) do not demonstrate
clinically significant psychological problems, which obviously limits the
implications of these studies for the practice of pediatric psychology.
On the other hand, it should be noted that several studies reviewed in the
JPP series did include criteria that helped to establish the clinical
significance of the problems that were treated. For example, Stark and her
colleagues' study of the impact of behavioral group treatment for encopresis
included failure of previous medical treatment for this problem as a
requirement for participation in their studies
(Stark et al., 1997;
Stark, Owens-Stively, Spirito, Lewis,
& Guevremont, 1990). Moreover, Finney et al.'s
(1989) aforementioned study of
treatment of abdominal pain required study participants to have episodes of
abdominal pain sufficient to affect activity. Children in these treatment
studies are likely to resemble children referred to pediatric psychologists
for management of such problems. Consequently, the findings from treatments
conducted with such samples would be more likely to generalize to the children
seen by pediatric psychologists in practice settings as compared with
psychological treatment studies of unselected populations such as children
with asthma selected from a clinic sample
(Vazquez & Buceta,
1993).
Neglect of Theoretical Issues in Evaluating Treatments
The Chambless et al. (1996,
1998) criteria were crafted to
judge empirical support for interventions, whether an intervention works, and
do not address theoretical questions such as why an intervention works. Though
the criteria have served the purpose for which they were intended, the neglect
of theory has certain consequences. For example, by not including theory
explicitly in reviews, this approach neglects hypothesized processes of change
and specification of how theory informs the operational principles and
implementation of tested treatments (Douglas-Kelly, Nixon, & Bickman,
2000). If a treatment is found to be successful but the theory that guides the
intervention is not specified, then the processes by which the effect was
achieved cannot be discerned. On the other hand, if a theory of
treatment-related change is clearly specified and linked to a successful test,
then the theory of change is also supported. Consequently, successful tests of
treatments closely linked to and guided by theory are much more likely to
advance the development of generalizable principles of change, which is an
important long-range scientific and clinical goal for treatments
(Bickman, 1987;
Kazdin, 2000;
Weiss, 1995). Other
researchers have noted that theory-based research is especially important to
the field of pediatric psychology in general
(Wallander, 1992), as well as
to research on psychological interventions with children with chronic illness
in particular (Bauman, Drotar, Leventhal,
Perrin, & Pless, 1997), but it has been underemphasized.
Systematic inclusion of theory in the reviews of treatment effects also has
pragmatic advantages for identifying the specific features of a successful
intervention model that are most effective, for whom, and under what
circumstances (Douglas-Kelley et al.,
2000). On the other hand, if the framework or theory that guided
how an intervention program was implemented is not clearly specified, negative
intervention effects may be difficult, if not impossible, to interpret because
they may reflect either a problematic program or intervention theory or a
failure to accurately test the program theory
(Douglas-Kelley et al., 2000).
For example, Gustafsson, Kiellman, and Lederblad (1985), cited in McQuaid and
Nassau (1999), found no
effects of family therapy on disease activity and morbidity of children with
asthma. However, it was not clear why these authors expected family therapy to
change the medical outcomes of children with asthma. The family therapy
protocol may have been implemented as expected, but the mechanism or theory
linking family therapy to improvement in medical outcomes for asthma may not
have been plausible. Because the theory that guided the treatment model was
not articulated in detail, it is impossible for readers to know.
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Recommendations |
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TopAbstractIntroductionHistory of Reviews of...Limitations of the Chambless...RecommendationsCaveats and Final...References |
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Given the success of the reviews of empirically supported treatments in JPP, there is no reason to throw the baby out with the bath water by making substantial changes in their structure and format. Nevertheless, this analysis suggests that the scientific and pragmatic value of JPP reviews of empirically supported treatment would be enhanced by expanding the information contained in the reviews as well as broadening types of invited and published reviews.
Expanding Information Contained in Reviews
As shown in Table I,
summaries of individual studies would be improved by including effect sizes to
allow readers to compare the strength of treatment-related effects across
different studies, populations, and treatment approaches. Information
concerning effect sizes would not only improve the specificity of the
conclusions and recommendations for future intervention research but provide
data that can be translated into information of primary interest to policy
makers (see McCartney & Rosenthal,
2000).
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Readers' appreciation of the clinical significance of empirically supported
treatments would be facilitated by including the following information in
reviews: (1) clinically relevant features of the samples that were studied
(e.g., whether these children were referred for treatment, what these problems
were, presence or absence of comorbid clinical problems or documenting
clinical relevance of the problems studied); (2) explicit reference to the
clinical significance (or not) of findings; and (3) clinical significance of
findings obtained based on specific criteria (see
Kazdin, 2000;
Kendall et al., 1999).
Investigators who conduct treatments with pediatric populations can
consider any number of options to describe the clinical relevance of a
particular sample of children who participate in treatment. For example,
studies of interventions to promote adherence to treatment for diabetes can
include information about whether problems with adherence are judged to be
interfering with medical management causing persistent hyperglycemia or
episodes of ketoacidosis. Other options include description that establishes
the clinical relevance of samples included in treatment studies, including
cutoffs that describe clinically significant problems on measures of
functioning (e.g., participation in activities or distress) and report changes
as a function of treatment. Explicit reference to the clinical significance or
potential clinical significance of findings obtained in treatment-related
studies and in reviews would help readers to assess the relevance of the
findings to their practice or research concerning treatment. However,
reviewers will not be able to make explicit statements about the clinical
significance of findings from reviews of specific studies unless researchers
have focused their analyses on this question. For this reason, investigators
who conduct treatment-related research should consider applications of methods
to describe clinical significance discussed earlier
(Kazdin, 2000;
Kendall et al., 1999).
Finally, the value of reviews would be improved by specifying the
theoretical basis of the tested interventions, including whether the
intervention was informed by a specific theory, the framework or theory that
guided implementation of the intervention, and to what extent this theory was
supported (Mellon & McGrath,
2000). It is difficult describe the theoretical underpinnings of
treatments if in fact the original articles did not contain explicit reference
to theory or tests of theory. Nevertheless, reviewers can pose relevant
questions about theory that relate to the type and nature of the interventions
studied.
One example of this approach was contained in McQuaid and Nassau's
(1999) review of empirically
supported treatments of disease-related symptoms in asthma, diabetes, and
cancer. In discussing interventions for childhood cancer, McQuaid and Nassau
provided an instructive discussion of alternative mechanisms by which nausea
and vomiting of patients who were undergoing chemotherapy for cancer might be
alleviated by imagery-based or cognitive relaxation treatments. These included
(1) distraction from sensations associated with chemotherapy by focusing
attention on more pleasurable imagery; (2) reduction of distress or arousal or
relaxation associated with specific images or activities may affect children's
symptom perception or physiologic processes such as gut motility or gastric
acid production directly; (3) enhancement of children's perceptions of control
over their chemotherapy side effects by helping them engage in activities that
have a positive effect. Including similar discussion of theoretical issues in
other reviews would serve to stimulate refinements and tests of theory.
Expanding the Types of Invited Reviews
While these recommendations will enhance the quality and comprehensiveness
of the information contained in reviews of empirically supported treatments,
they also need to be tempered by realism. In treatment research, especially
new areas, there may be insufficient information to conduct meta-analyses or
to articulate explicit theories of why an intervention works. In such
instances, the current or traditional approach to empirically supported
reviews will be most useful, though the recommendations to improve the reviews
by reporting effect sizes, articulating theory, and describing clinical
significance are still relevant.
In other areas of work, the research concerning particular treatments may have developed to a point where other types of reviews would be more likely to extend scientific knowledge and should be invited. Table II describes the types of reviews that might be valuable at different phases of intervention research. For example, for treatments for which empirical support has not been established (Phase 1), the first scientific priority is to document whether the treatment is effective and to synthesize these findings. This is the purpose of the reviews of the empirically supported interventions published in JPP thus far. The description of Phase 1 reviews would be enhanced by inclusion of the information noted in Table I whenever such information is available from the original studies.
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In Phase 2, studies of intervention research and reviews of this work have
matured to the point where the primary scientific question is no longer to
document whether an intervention works but to ask more refined questions, such
as how strong are the treatment effects. What factors are associated with
greater or lesser effects? Such questions are best addressed by using
meta-analysis. Meta-analyses of treatments identified by reviews as
established or efficacious would provide a comprehensive analysis of how
effect sizes vary 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.). Such information would not
only document differences in the strength of treatment effects across
different studies but would suggest next steps in treatment research that has
been largely untapped in the field of pediatric psychology (for an exception,
see Kibby, Tyc, & Mulhern,
1998).
Another potential focus of Phase 2 intervention research and the reviews of
such work is to go beyond statistical significance to provide a formal
documentation of clinical significance using appropriate statistical methods
(e.g., measures that include cutoffs reflecting clinically significant change
and indicators of improved functioning)
(Kazdin, 1999;
Kendall et al., 1999). (See
previous section for examples.) Phase 2 reviews of intervention research might
also focus explicitly on documenting other areas of clinical significance,
cost-effectiveness, or social validity of interventions. Such information is
of primary importance to practitioners, families, as well as insurers
(Drotar & Zagorski, 2001;
Walders & Drotar, 1999).
Phase 2 research might also involve application of empirically supported
treatments to a range of clinical samples and eventual reviews of this
evidence.
In the third phase of intervention research, the primary scientific
interest is in documenting why treatment works. This can be accomplished by
testing the efficacy of interventions guided by specific theoretical models,
determining which specific components of treatments are most critical to
obtain effects, and testing generalizability of intervention models across
settings. One of the most compelling reasons to conduct reviews of Phase 3
research relates to the need to generalize the principles of treatment models
across clinical settings. The generalizability of treatments may ultimately
depend on the degree to which theoretical principles of treatment models can
be clearly specified and used to develop treatments sufficiently powerful to
be effective in multiple settings (Kazdin,
2000). Consider some examples of such research. The theoretical
underpinnings of multisystemic therapy (MST) has enhanced the
operationalization of key principles of this model intervention and are
critical ingredients in the generalizability of this approach to a range of
settings (Henggeler & Randall,
2000). Similarly, the success of programmatic research on
interventions to promote children's coping during painful medical procedures
relates in no small measure to attention to theory in the context of clinical
application (Blount, Bunke, & Zaff,
2000a 2000b).
The contributions of Phase 3 reviews are to identify and specify the theoretical models and framework that guide psychological treatments, describe the nature and level of empirical support of theoretical models based on empirical data, refine and develop these models based on treatment findings, and document the generalizability of theories of treatments for different clinical problems and pediatric populations.
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Caveats and Final Recommendations |
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Readers should recognize several limitations of this critique and recommendations. With respect to the specific recommendations for broadening the types of reviews published, reviewers need to rely on available scientific evidence to construct their reviews. Consequently, it is difficult to separate what is contained in reviews of treatments from the nature of the treatment-related research reviewed. Meta-analysis is by no means a panacea for the methodological and pragmatic problems of conducting and reviewing intervention research and has several methodological limitations (DerSimonian & Levine, 1999
; Durlak & Lipsey,
1991; Eggers & Smith,
1997). Moreover, the comprehensiveness and value of meta-analysis
depends on the data generated concerning a particular treatment. In some areas
of treatment research, small numbers of studies or sample sizes limit
applications of meta-analysis, although statistical methods to manage smaller
samples are available (Dunlap, Cortina,
Vaslow, & Burke, 1996;
Levin & Wampold, 1999).
Nevertheless, the success of meta-analytic approaches in describing scientific
progress and suggesting new directions in child psychotherapy research
(Kazdin, 2000) is a powerful
argument for including them in the scientific agenda for reviews of
empirically supported treatments in pediatric psychology.
Recommendations to solicit and publish reviews that focus on clinical and
theoretical significance of interventions depend on the extensiveness and
quality of information related to these topics available in original research
reports of treatment research. My belief is that clinical relevance of science
concerning treatments in pediatric psychology will be enhanced if
investigators address clinical relevance and theoretical significance in
designing their research. To accomplish this difficult task, investigators can
build on available precedents for clinically relevant research concerning
treatments (Pinto & Hollandsworth,
1989; Wysocki et al.,
1997) and theory-guided intervention models
(Ireys, Sills, Kolodner, & Walsh,
1996), heed cogent recommendations to conduct treatment research
in clinical settings (Weisz,
2000), and include outcome measures that reflect clinical
relevance (Kazdin, 2000) and
social validity (Foster & Mash,
1999). The continued growth of a clinically relevant science of
intervention research and the reviews that result from such research may
depend on the flexibility and ingenuity of researchers in using multiple
methods to document the impact of interventions with a wide range of
populations. Case studies and series, program evaluations, and randomized
controlled trials are all needed to develop a clinically relevant and
generalizable science of intervention research. Reviews of empirically
supported treatments should reflect this multifaceted research agenda.
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Acknowledgments |
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The hard and extraordinary work of Susan Wood in processing this manuscript is gratefully acknowledged.
Received September 1, 2000; accepted February 26, 2001
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