The ORBIT Model:
A Phased Approach to Behavioral
Intervention Development
Susan Czajkowski, Ph.D.
“Translating Ideas into Interventions” Workshop
December 6 - 7, 2010
Bethesda, MD
The standard NIH Translational
Research Model …
T1 Translation
Bench
T2 Translation
Bedside
Public
Health
…. applied to Behavioral Research
T1 Translation
bBSSR
T2 Translation
Behavioral
Intervention
Public
Health
T1 research – biomedical
(drug development) model
Bench
Bedside
Drug Development
Investigation of
biologic
mechanisms of
underlying disease
Phase I
Phase II
Phase III
 (safety:
 (biologic activity:  (efficacy &
“dose –finding”) “dose-response”)
effectiveness)
Identification of
biologic targets
for intervention
Moving animal findings
to human application
Feasibility Pilot
Studies
T1 research – behavioral model
Behavioral
Intervention
bBSSR
Behavioral intervention development
Investigation
of biologic &
behavioral
mechanisms of
RF’s & disease
Identification of
behavioral targets
for intervention
Phase I?
Phase II?
Phase III
 safety, dose biologic &
 efficacy &
finding, tolerance
behavioral
effectiveness
activity, doseresponse
Moving animal findings
to human application
Feasibility Pilot
Studies
Requirements/features of the ORBIT RFA
 Application required detailed Plan for Intervention
Development which describes timeline, planned studies, and
milestones/criteria for moving to next phase of the
intervention development process
 Intervention Development Plan involved applicant’s best
estimate of what is required at each stage to fully develop
intervention of interest – plans were to be as specific as
possible, but with recognition that the plan may change
during development of the intervention
Phases of Intervention Development
Defining the Intervention (6 months – 1 year)

Experimental and observational studies to refine understanding
of the basic biological, behavioral or social science research
finding(s) or concepts being used in relation to the particular
intervention (e.g., dietary or physical activity behaviors) and
population of interest.

Formative (qualitative) research to engage the community of
participants in the development of strategies (“user-centered”
design), explore the acceptability of the approach being used,
and assess attitudes, norms, values, and meanings of relevance
to the population being targeted in order to guide development
of the intervention.
Phases of Intervention Development (cont’d)
Characterizing the Intervention’s Effects (2 – 3 years)

Early phase (I & II) trials to evaluate safety, tolerability & to characterize
effects of interventions or intervention components (e.g., examine effects
of varying an intervention’s content, timing, mode of delivery, intensity,
duration and frequency of contact on outcomes of interest).

Studies using adaptive designs and pre-specified decision rules based on
participant characteristics and responses to treatment to customize the
intervention strategy to the individual, evaluate for whom a treatment
should be employed, or when it should change over time in order to
maximize its effects.

Studies using modeling techniques and systems science approaches (e.g.,
network analyses and systems dynamics approaches) to develop
interventions and suggest how, when and where they should be targeted
within a social group, family, health care or other system to achieve
maximum benefit
Phases of Intervention Development (cont’d)
Assessing Feasibility and Refining the Intervention (1 - 2 years)

Qualitative research (focus groups, ethnographic interviews)
to determine the acceptability and feasibility of the intervention
within the populations and setting(s) of interest.

Pilot/feasibility studies to





refine intervention and measurement procedures
gain experience in and information concerning screening, recruitment and
retention of the target population (e.g., estimates of yield, pre-testing of
screening/recruitment procedures)
determine estimates of variability and levels of response in the target population
obtain preliminary information about sustainability and cost-effectiveness of the
intervention, and
engage community residents and leadership in preparation for future large-scale
randomized trials of the intervention.
ORBIT Model: Key Features
 Progression from basic to more clinical/applied stages
 Flexibility in terms of number & types of studies within phases
 Duration of each stage can vary depending on # of studies and
needs of each study
 Each phase includes milestones/criteria for moving to next
phase of the intervention development process
 The number, order & types of studies required at each stage
may change as researcher moves through phases (allows for
additional studies or modification of studies in later stages as
needed)
 Flow is bi- not uni-directional -- may need to go back to
previous phases depending on findings at any given stage