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Journal of Pediatric Psychology, 40(10), 2015, 1034–1040

doi: 10.1093/jpepsy/jsv049
Advance Access Publication Date: 6 June 2015
Topical Review

Topical Review: Translating Translational


Research in Behavioral Science
Kevin A. Hommel,1,2 PHD, Avani C. Modi,1,2 PHD,
Carrie Piazza-Waggoner,1,2 PHD, and James D. Myers,1,2 PHD
1
Cincinnati Children’s Hospital Medical Center and 2University of Cincinnati College of Medicine
All correspondence concerning this article should be addressed to Kevin A. Hommel, PHD, Division of Behavioral

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Medicine and Clinical Psychology, MLC-7039, Cincinnati Children’s Hospital Medical Center, 3333 Burnet Avenue,
Cincinnati, OH 45229, USA. E-mail: [Link]@[Link]
Received November 7, 2014; revisions received March 25, 2015; accepted May 7, 2015

Abstract
Objective To present a model of translational research for behavioral science that communicates
the role of behavioral research at each phase of translation. Methods A task force identified
gaps in knowledge regarding behavioral translational research processes and made recommenda-
tions regarding advancement of knowledge. Results A comprehensive model of translational
behavioral research was developed. This model represents T1, T2, and T3 research activities, as
well as Phase 1, 2, 3, and 4 clinical trials. Clinical illustrations of translational processes are also of-
fered as support for the model. Conclusions Behavioral science has struggled with defining a
translational research model that effectively articulates each stage of translation and complements
biomedical research. Our model defines key activities at each phase of translation from basic dis-
covery to dissemination/implementation. This should be a starting point for communicating the
role of behavioral science in translational research and a catalyst for better integration of biomedi-
cal and behavioral research.

Key words: behavioral; behavioral research model; biopsychosocial; translational.

Discussions and debates about the application of new and additional challenges exist, including nonad-
translational research have traditionally focused on herence to treatment, health care seeking, complemen-
the translation of basic biomedical research findings tary and alternative medicine use, etc. This is
into clinical trials and practice. Although models of particularly true in pediatrics, as patients in this seg-
translational research have been proposed in response ment of the health care population are developing
to the National Institutes of Health (NIH) roadmap behaviors and lifestyle habits that will protect or place
initiative (Dougherty & Conway, 2008; Westfall, them at risk for health problems throughout their
Mold, & Fagnan, 2007), they do not accurately repre- lives.
sent the role of behavioral science in translational With exorbitant health care costs, reaching $2 tril-
research, despite evidence that behavior has significant lion or $6,000 per capita in 2005 (Congressional
ramifications for morbidity and mortality. For over 35 Budget Office, 2007), and current worldwide eco-
years, we have known that 40%–50% of premature nomic trends, it is imperative that the pace of transla-
death in the United States is attributable to behavior tional research be accelerated to maximize the impact
and lifestyle (e.g., smoking, obesity, alcohol use; on patient care in the most cost-effective manner.
Schroeder, 2007; U.S. Department of Health Better understanding of the role of behavior in disease
Education and Welfare, 1979). While there has been onset and progression and integration of behavioral
progress in prevention and treatment of behavioral science into biomedical research has the potential to
factors that promote disease, much work remains, and advance and accelerate translational research.

C The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology.
V
All rights reserved. For permissions, please e-mail: [Link]@[Link] 1034
Translating Translational Research 1035

Moreover, applications in pediatric behavioral science provided excellent models of translational research in
have the potential to have widespread and long-stand- alignment with the NIH roadmap and describe activ-
ing impact, as advances in science would have implica- ities traditionally associated with behavioral science,
tions across the lifespan. However, a considerable such as observational and survey research. Dougherty
misperception and lack of consensus regarding how and Conway also emphasize the role of behavioral sci-
and where behavioral science fits into existing transla- ence in quality improvement research. However, there
tional research models remain as critical barriers to is no discussion in these models regarding the multiple
communication and collaboration between behavioral ways in which behavioral science can be integrated
and biomedical science. To address these issues, a task into biomedical research at each phase of translation
force composed of clinical and research psychologists or the benefits of such an approach. Thus, the existing
was formed to review the existing models of transla- models, emphasizing biomedical research translation,
tional research in the empirical literature, identify are less useful to behavioral science because they are
gaps of knowledge with respect to behavioral transla- misleading and/or do not capture the types of behavio-
tional research processes, and make recommendations ral science activities that occur at each phase, which
regarding advancement of knowledge in the general consequently de-emphasizes the role of behavioral sci-

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scientific community. In this article, we propose a ence across the translational spectrum. Further, these
comprehensive model of translational research for models suggest a fragmented approach to science in
behavioral science to communicate the role of behav- which behavioral and biomedical processes operate
ioral research at each phase of translation and advance independently, which is inaccurate and, hence, less
translational research collaboration between behavio- helpful to biomedical translational research efforts.
ral and biomedical science. Thoughtful integration of behavioral and biomedical
translational research is imperative given the large role
patient behavior plays in health outcomes. Relevant
examples of such integration are evident in the body
Overview of Existing Translational of research that has led to biobehavioral treatment for
Research Models pediatric headache, which incorporates the use of cog-
Though definitions of translational research vary, it nitive-behavioral pain management techniques,
has been historically described as the process of taking including biofeedback, as well as pharmacotherapy
knowledge gleaned from basic science research and (Powers, Gilman, & Hershey, 2006), and treatment
applying it to human clinical trials and ultimately for depression, for which it has been demonstrated
patient care. This gradual translation occurs over the through a large number of clinical trials that the most
course of multiple observational studies, phases of effective treatment is a combination of medication and
clinical trials, and dissemination/implementation of cognitive-behavioral therapy (CBT; March et al.,
evidence-based practice. Although a detailed historical 2007). Better communication in the general science
discussion of translational research is not within the community of the value behavioral science can bring
scope of this article, the interested reader is referred to to health care research will result in better research
more detailed articles on the topic (Dougherty & methodology, more comprehensive analysis of health
Conway, 2008; Westfall et al., 2007; Woolf, 2008) as care problems, and expanded articulation of mecha-
well as the Institute of Medicine ([Link]), the nisms of action, particularly at latter stages of
Agency for Healthcare Research and Quality (www. translation.
[Link]), and the NIH ([Link]). Bender and colleagues (Bender, Aloia, Rankin, &
Behavioral science has neglected to define itself well Wamboldt, 2011) recently presented a model of trans-
with respect to translational research and, impor- lational behavioral research that articulates the process
tantly, communicate its role in translational research of translation within clinical research in a stepwise
to the broad scientific community. The published liter- manner, from observational health behavior research
ature predominately focuses on translating random- to clinical effectiveness evaluation. However, this
ized controlled trial (RCT) research into clinical model is limited in scope and neglects to address the
practice, which is only one piece of translational contributions and role of basic behavioral science or
research. Discussions of translational research have the role of behavioral research in dissemination, imple-
poorly articulated the role and placement of behavio- mentation, or quality improvement research. In our
ral science in extant models. Woolf (2008) highlighted proposed model, we describe each phase of transla-
the role that behavioral science has in translating tional behavioral research and the types of research
knowledge of new treatments and prevention methods activities that occur at each phase, consistent with the
into practice, but also described behavioral science as Dougherty and Conway (2008) model. We also pro-
a “basic science,” which conveys a limited scope of vide definitions for Phase 1, 2, 3, and 4 behavioral clin-
contributions behavioral science makes. Westfall and ical trials that parallel U.S. Food and Drug
colleagues (2007) and Dougherty and Conway (2008) Administration clinical trial phases.
1036 Hommel, Modi, Piazza-Waggoner, and Myers

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Figure 1. Behavioral science translational research model.

Model of Translational Behavioral Research trials are controlled trials in which preliminary data
The Behavioral Science Translational Research Model on efficacy, dosage (i.e., number of treatment ses-
(see Figure 1) illustrates the types of research, includ- sions), and side effects (e.g., toxicity resulting from
ing specific examples, that occur at each stage of trans- successful treatment targeting medication adherence)
lation, with basic behavioral science (e.g., behavioral are obtained using a patient sample that is larger than
theory testing), clinical efficacy knowledge, and clini- those in Phase 1 trials. These trials can be blinded or
cal effectiveness knowledge representing the mile- unblinded. Phase 3 trials are blinded RCTs involving
stones along the translational research continuum. larger patient samples with the goal of evaluating effi-
The translation to applied science (T1) bridges basic cacy or effectiveness. Phase 4 trials are large multisite
science and clinical efficacy and may involve epide- trials that are focused on long-term health outcomes
miologic observational studies, case studies, or Phase and cost analysis.
1 trials. Translation to patients (T2) represents the To illustrate the translational research continuum
bridge between clinical efficacy and effectiveness and using this model, we provide a general example from
may involve meta-analyses, Phase 3 trials, or health treatment adherence promotion research. A basic
services research. Finally, translation to practice (T3) behavioral science study might examine the behavio-
bridges the gap between clinical effectiveness research ral/emotional factors and processes within families
and improved quality of health care and population that predict treatment adherence in children with
health and may involve implementation or quality asthma. T1 translation of this study could be a Phase
improvement research. 1 trial examining feasibility and acceptability of a brief
In behavioral clinical trials, the objective of each family-based intervention to improve adherence by
trial phase obviously differs from pharmaceutical trial targeting behavioral functioning with four or five fam-
phases, though the ultimate goal is the same. In Phase ilies of children with asthma. A Phase 2 trial might be
1 behavioral trials, the primary objective is to establish a small controlled clinical trial of this behavioral inter-
feasibility and acceptability of the treatment protocol. vention compared with treatment as usual to establish
These trials are conducted with small sample sizes that preliminary clinical efficacy in a sample of children
may involve patients or healthy individuals. Phase 2 with asthma and their parents. T2 translation would
Translating Translational Research 1037

then establish clinical efficacy using a Phase 3 multisite slowed application of important research findings in
RCT with children with asthma and their parents. clinical practice. There have been numerous examples
This study could also compare the family-based inter- over the past several years illustrating the slow process
vention with an educational intervention used as a of adopting research findings into practice. These
control group. Clinical effectiveness would be estab- include the 25-year span between demonstration of
lished via a Phase 4 trial of the intervention using a efficacy to implementation of b-blockers for standard
large clinical sample representative of those seen in treatment of myocardial infarction (Dougherty &
regular practice within the clinic-based setting and Conway, 2008) as well as evidence-based behavioral
examining long-term health outcomes (e.g., pulmo- treatments for obsessive-compulsive disorder (OCD),
nary functioning, number of asthma episodes). T3 encopresis, enuresis, and feeding disorders, among
translation might then use quality improvement meth- others, which are still not uniformly delivered as
odology and large-scale dissemination tactics to imple- standard care.
ment the intervention in general clinical practice and
examine the impact at a health care systems level (e.g.,
Translational Behavioral Research Examples
emergency room visits, hospitalizations) and costs.

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Table I provides an additional illustration. In an effort to address the issue of adopting research
findings into practice, our team has successfully navi-
gated the translational research spectrum in targeted
Benefits of Translational Behavioral Research conditions to improve care delivery. The first example
Model involves behavioral treatment for regimen adherence
There are clear advantages to using a translational in cystic fibrosis (CF). CF is a life-threatening autoso-
behavioral research model. It provides a coherent con- mal recessive disorder, which results in thick mucus in
ceptual basis for researchers and clinicians regarding the respiratory and digestive tracks. As such, lung
the role and impact of behavioral science on health functioning and nutrition are critical elements to the
outcomes. In addition, it can facilitate understanding care of these patients. CF requires a highly demanding
of how to integrate behavioral and biomedical scien- medical regimen, which includes dietary changes,
ces in a complementary manner by providing parallel medication, and enzyme use, as well as daily airway
processes at each translational stage that can be com- clearance. A large body of research exists in the medi-
pared with biomedical models for synergistic opportu- cal literature that has demonstrated the importance of
nities. It can also provide a model for a continuum of weight gain/nutrition on lung functioning (Konstan
translational research: A blueprint with specific steps et al., 2003), needed caloric intake and enzyme use for
and key activities at each step for behavioral scientists sufficient weight gain (Borowitz, Baker, & Stallings,
to follow in order to accelerate adoption of research 2002; Ramsey, Farrell, & Pencharz, 1992), and even
findings into practice and directly impact patient out- which types of air way clearance are most efficacious
comes. Scientists sometimes operate in silos of transla- (McIlwaine, 2007). Similarly, there is a strong litera-
tion (i.e., conducting only observational research, only ture within behavioral medicine/pediatric psychology
Phase 3 trials, etc.) and do not actively pursue the next evaluating how to best meet these medical needs for
phase of translation toward patient care, resulting in children with CF and assisting families in reaching

Table I. Example of Research Progression Through Translational Stages

Basic behavioral T1: Translation to Clinical efficacy T2: Translation to Clinical effective- T3: Translation to
science applied science knowledge patients ness knowledge practice

Examination of Observational Phase 2 clinical Phase 3 compara- Dismantling study Implementation of


patterns of medi- study of medica- trial examining tive effectiveness to examine most behavioral inter-
cation nonadher- tion adherence in dosing and pre- trial examining effective compo- vention for nonad-
ence and clinical liminary efficacy effect of behavio- nents of behavio- herence across a
resulting drug population. of behavioral ral intervention ral intervention. large number of
efficacy and Phase 1 feasibility intervention for vs. chronic con- Phase 4 clinical sites/practices.
tolerance in trial of behavioral nonadherence in dition support trial examining Use of quality
animal models. intervention tar- clinical group interven- long-term out- improvement meth-
geting non- population. tion on health comes and cost- ods to determine
adherence. outcomes of effectiveness optimal approach
interest. of behavioral to implementation
intervention. and adherence to
treatment guide-
lines across health
care system.
1038 Hommel, Modi, Piazza-Waggoner, and Myers

these goals. This line of research includes a number of best practice airway clearance behaviors and techni-
T1 studies, which are observational or small case ser- ques; and contingent positive reinforcement in the
ies that assess patient-specific and family systems fac- form of a token economy.
tors, which impact meeting dietary intake goals The multidisciplinary unit-wide approach to the
(Powers et al., 2002) or identifying barriers to various project was novel. Although a pediatric psychologist
aspects of the treatment regimen (Modi & Quittner, was integrally involved in the whole quality improve-
2006). For example, Powers et al. (2002) identified ment process, the RTs were responsible for ongoing
that mealtime duration, family mealtime interactions, management and implementation of the strategies that
and problematic mealtime behaviors all impacted were taught. This T3 project demonstrated consider-
adherence to intake recommendations, while Modi able improvements with quality (from 21% to 73%)
and Quittner (2006) identified barriers to airway and quantity (from 41% to 64%) of airway clearance
clearance (92% of the sample) and nutrition (69% of adherence. Following the implementation of this proj-
the sample), including child oppositional behaviors, ect, the consistency of conducting quality airway
forgetting, and poor time management. clearance routinely has been maintained on the unit.
The next series of studies aimed to develop inter- A second example demonstrates another T3

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ventions to address behavioral concerns of children level project, which served to improve the delivery
with CF with the goal of improving both child behav- of evidence-based care in the outpatient setting.
iors and pulmonary functioning and nutritional out- OCD is a condition for which there is a well-
comes (“Clinical Efficacy Knowledge” in proposed established empirically based treatment, CBT with
model). For example, Powers and colleagues (2005) particular emphasis on exposure and response preven-
developed an efficacious behavioral intervention that tion (March & Mulle, 1998). Before the implementa-
provided guidelines on reducing meal length, modeled tion of this T3 project, psychologists varied greatly in
and taught behavior management, and used goal set- their adherence to this evidence-based protocol, and
ting to improve toddler adherence to nutritional guide- thus patient outcomes varied. The over-arching goal
lines and height/weight growth. Similarly, researchers of this long-term project was to assure that any patient
have developed interventions that improve adherence presenting to the Division of Behavioral Medicine and
to the CF regimen through contingency management Clinical Psychology at Cincinnati Children’s Hospital
(Bernard, Cohen, & Moffett, 2009), family therapy Medical Center for treatment of OCD would receive
(Quittner et al., 2000), and behavioral strategies the prescribed evidence-based treatment, effectively
(Bernard & Cohen, 2004; Stark et al., 1996). and efficiently, regardless of the clinician treating the
The next important step in translational research patient. While most psychologists in the division had
was to take these findings and apply them to a medical received training in CBT, including Exposure and
inpatient unit (“T3” in proposed model), which cares Response Prevention, mastery of these skills varied
for children and adolescents with CF at Cincinnati and the first step to this project involved a day-long
Children’s Hospital Medical Center (Ernst et al., seminar in the treatment of children and adolescents
2010). In 2001, increased national focus was placed with OCD. The improvement team then developed a
on the discrepancy between recommended (evidence- manual (“T2” in proposed model) that included guid-
based) treatment and actual care delivered (Institute of ance on the components of treatment and relevant
Medicine, 2001). Quality improvement/health care resources (e.g., exposure hierarchy forms, fear ther-
systems research is an excellent tool for applying mometers, symptom severity measures). To further
evidence-based care within the complicated real-world build on the information provided in the initial train-
setting, where each system has unique barriers regard- ing and the treatment manual, the team provided peri-
ing implementation. Within our CF center, during an odic 1-hr continuing education presentations. These
admission for a pulmonary exacerbation, airway trainings aimed to increase mastery of skills by
clearance is prescribed four times a day. Baseline data addressing, for example, means of conducting expo-
indicated that only 41% of patients were receiving air- sures with challenging OCD symptoms. Ongoing case
way clearance four times a day and the quality of the presentations with group discussion further facilitated
airway clearance was poor, with only 21% of treat- consistent use of evidence-based strategies, as well as
ments meeting best practice guidelines. Ernst and col- the implementation (“T3” in proposed model) of rele-
leagues (2010) conducted education workshops with vant tools that were tried and proved to be useful
respiratory therapists (RTs) and implemented a multi- through the “small tests of change.”
disciplinary intervention (pulmonologists, RTs, psy- Perhaps the most useful improvement resulting
chologists) targeting patient behaviors (“T3” in from this project was the development of a session-by-
proposed model). The intervention included contract- session outcome measure (“T1” in proposed model)
ing with the patient airway clearance expectations, that greatly enhanced the value of services and patient
schedule of treatments, and type of treatment patient experience. The project initially used an outcome
will do during the admission; behavior monitoring of measure that was too cumbersome for routine
Translating Translational Research 1039

practice, so the team developed a simple measure that biomedical and behavioral researchers in the early
ascertained the child’s control of symptoms, distress stages of theoretical and applied research will help
associated with the experience of OCD, and func- facilitate a comprehensive understanding of these con-
tional impairment, which are all goals of treatment. ditions and facilitate application at the bedside. In
This measure was found to be highly reliable (r ¼ .89 addition, the scientific community’s traditional cate-
with gold standard) and more efficient. The team used gorization of research (i.e., biomedical vs. behavioral,
quality improvement methodology (“T3” in proposed basic vs. clinical) may not encourage investigators
model) to “spread” the use of this measure so that who are seeking funding/publication to examine both
clinicians were using it consistently and regularly. the biological and behavioral underpinnings of condi-
Two years following the end of the project, this meas- tions or to work on various projects along the transla-
ure is used in 95% of treatment sessions. Its use pro- tional spectrum. Unfortunately, this approach results
vides immediate feedback about progress on goals and in restricted collaboration and creativity, both of
patterns of symptom severity, prompting discussion which are needed to successfully integrate biomedical
and problem-solving to move treatment along at a and behavioral science.
more efficient and effective rate. The resulting briefer Our field’s ability to bridge the collaborative gaps

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course of treatment yields benefit to patients and their between behavioral and biomedical science has sub-
families by bringing about quicker relief from symp- stantial implications for research, practice, and public
toms and value in the form of reduced health care health policy. A broad understanding of disease etiol-
costs. ogy and sequelae, both medical and behavioral, will
These projects are two exemplars for the bench to inform development of better therapies that can be
bedside translation in behavioral health; yet, there are tested and implemented in practice. This approach
numerous other areas in which behavioral research would allow for better understanding of the impact of
has yielded significant improvements for patients disease on medical outcomes as well as behavioral out-
across the proposed translational model. However, comes including quality of life, psychosocial dysfunc-
there are several areas in which efficacious treatments tion, and functional disability. Moreover, a
are not implemented at the bedside. Further, despite comprehensive translational approach would allow us
the potential impact on population health, T3 transla- to better account for health care costs for treatment of
tional work is uncommon across the health care sys- various conditions, which would significantly inform
tem, particularly in behavioral science. One recent health care policy and standards of practice.
biomedical example of T3 translation in pediatric
inflammatory bowel disease has demonstrated
improvement in remission rates within a large multi-
center collaborative in which standardization of care
is heavily emphasized (Crandall et al., 2011). With Conclusions
new health care system policies increasing the focus Behavioral science has struggled with defining a
on integrated care at lower cost, combined with a translational research model that effectively articu-
growing demand for complex and chronic care, it is lates activities at each stage of translation and com-
increasingly important for behavioral and biomedical plements biomedical translational research
scientists and clinicians to streamline and expedite the processes. Our model defines key activities at each
translational process. phase along the translational process from basic dis-
covery to dissemination and implementation of evi-
dence-based treatments. There have been recent
Remaining Challenges exemplars for translating behavioral trial research
to the bedside, though many other conditions could
There are several barriers that exist to widespread
be effectively treated with better implementation of
adoption and application of this model in research
behavioral treatments into practice. Thoughtful inte-
and practice. The perceived need to fit behavioral
gration of biomedical and behavioral science early
translational research into a traditional biomedical
in the translational spectrum is necessary to realize
translational model has resulted in significant diffi-
the full potential benefit of comprehensive multidis-
culty in behavioral science’s ability to coherently
ciplinary health care from treatment outcome and
define its role in the translational process. The pro-
cost savings perspectives. This model should serve
posed model, however, provides a complementary
as a starting point for communicating the role of
approach that indicates an integration of biomedical
behavioral science in translational research and as a
and behavioral research. Indeed, the lack of thought-
catalyst for integrating biomedical and behavioral
fully integrated biobehavioral research in many medi-
research more thoroughly.
cal and behavioral conditions has slowed the
translational process. Collaboration between Conflicts of interest: None declared.
1040 Hommel, Modi, Piazza-Waggoner, and Myers

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