Table 1.

Areas of Focus in Designing a Feasibility Study

Area of Focus	Definition	Application to the SADE Study
Applicability	How do the intended recipients, both targeted participants and those implementing the program, react to the intervention?	How do children with ASD and TD ages 6–12 respond to SADE? How do their parents and dental professionals react to the intervention?
Demand	Do people in the target population see a need for the intervention? Are they willing to try it?	Results of prior research have indicated that children with ASD experience great difficulty receiving oral care at the dentist and that sensory sensitivities are associated with this difficulty (Stein, Polido, & Cermak, 2012, 2013; Stein, Polido, Mailloux, Coleman, & Cermak, 2011; Stein, Polido, Najera, & Cermak, 2012).
Implementation	What is the extent to which, likelihood that, and manner in which an intervention can be fully implemented as planned and proposed?	The population at our recruitment site were largely Spanish-speaking Latinos. Latinos are underrepresented in medical research; there is not good evidence regarding whether this situation is due to their views on research, a lack of interest in participating, or barriers in recruitment methods. Moreover, the dental clinic reported a 30%–40% no-show rate; therefore, we were concerned about our ability to retain participants once recruited. Questions we addressed included Is there a sufficient number of eligible participants? Are people willing to participate in the study? What are the most effective methods of recruitment? Are families and dentists willing to allow videotaping during dental procedures? Can ASD diagnoses from community professionals be used, or is additional verification of diagnosis necessary? Do the participants understand the questions in the data collection assessments? Will participants tolerate placement and wearing of the electrodes? Will we be able to retain participants? Within what range of ASD severity will children with ASD be able to participate? What are the follow-up rates, response rates to questionnaires, and adherence and compliance rates?
Practicality	To what extent can an intervention be delivered when resources, time, commitment, or some combination of these are constrained in some way?	What are the constraints of implementing the intervention in a large dental clinic in a children’s hospital? What will we need in terms of person hours for the consent process, verification of autism diagnosis, questionnaire completion, dental cleaning, and video analysis? Will adequate space (private room for dental cleaning) be available? Are there hospital policies or procedures that need to be considered to obtain approval to implement the intervention?
Adaptation	Will procedures need to be changed to be appropriate in a new situation? It is important to describe the actual modifications that are made to accommodate the context and requirements of a different format, media, or population.	See description of SADE adaptations in Table 2.
Integration	What level of system change will be needed to integrate a new program or process into an existing infrastructure? Will change in the organizational setting or the social or physical environment be necessary?	To what extent will the dental staff be willing to incorporate the SADE process into their daily routine? Can we work with the Cancer Research Informatics Core at the university’s cancer center to develop a database management system?
Expansion	What is the potential for success of an already-successful intervention with a different population or in a different setting?	Our program was based on an application of SADE with young children with intellectual and developmental disabilities in a dental clinic in Israel (Shapiro, Melmed, Sgan-Cohen, & Parush, 2009). We wanted to examine its use in the United States with a different population.
Limited-efficacy testing	Many feasibility studies are designed to test an intervention in a limited way such as with a convenience sample, with intermediate rather than final outcomes, with shorter follow-up periods, or with limited statistical power.	We used outcome measures, randomized controlled group assignment, and intervention procedures designed for our final study; however, we did use a smaller convenience sample. Will physiological and psychological outcome measures detect differences? Given the small sample size, are the findings in the hypothesized direction? Given the obtained effect sizes, what sample size is needed for a full-scale RCT? Is the intervention effective for both TD and ASD groups? Do preliminary findings suggest questions to ask about subgroups of children for whom the intervention may be more or less effective?

Note. ASD = autism spectrum disorder; RCT = randomized controlled trial; SADE = sensory-adapted dental environment; TD = typically developing.