Transitioning From Development to Efficacy Trial: Challenges Faced by An Autism Intervention Study

Background: The research process is comprised of sequential phases designed to systematically determine the effectiveness of an intervention. However, differences in phase characteristics make transitioning between phases challenging. While there is a body of literature discussing the transition from efficacy to effectiveness trials, there is a paucity of information on the challenges specific to the preceding transition from intervention development to efficacy trial, which is thought to be equally important to translation (Whittenmore & Grey, 2002). The current study responds to this gap by examining the specific challenges accompanying this transition, using a case study of a school-based intervention for preschool students with autism.

Objectives: The aims of this qualitative study were to: (a) illustrate the challenges and issues raised during the transition from intervention development to multi-site intervention efficacy trial in the field of autism; (b) describe lessons learned using an autism intervention study as a case example; and (c) provide suggestions for researchers seeking to fund and complete these two phases of the research process.

Methods: The school-based Advancing Social-communication And Play (ASAP) intervention for preschoolers with autism was developed and refined through a four-year development grant (IES goal 2), and the efficacy of the fully-developed intervention is currently being tested through an efficacy trial grant (IES goal 3) conducted at four research sites across the U.S. Issues and challenges related to the transition between these two research phases have been documented by the research team, and solutions have been trialed and implemented. Based on systematic qualitative analysis of the documentation of these challenges and solutions in research team meeting notes, recurring themes were derived using a grounded theory approach (Glaser & Strauss, 1967). This approach allowed the researchers to reverse-engineer hypotheses through a process of substantive coding, categorization, and melding of deductive and inductive reasoning. Due to the nature of the data and the research team’s lack of a-priori theories, this approach to data analysis was most appropriate and produced the richest results possible.

Results: Preliminary themes that emerged from the documentation of the transition were in the following categories: consistency-related issues/solutions (e.g., moving to larger-scale monitoring of assessment/coding fidelity/reliability); statistical and methodological issues/solutions (e.g., ensuring adequate statistical power for a larger-scale study); and single site to across-site issues/solutions (e.g., variations in classroom characteristics across sites). Presentation of results will expand on these categories to provide a richer understanding of the myriad issues and processes inherent in the transition between these two research phases.

Conclusions: Implications for this study include an improved understanding of potential issues in transitioning between initial research phases, and strategies for addressing these challenges. Highlighting such issues and solutions has the potential to produce more rigorous research and more efficient translation of research findings into practice (Glasgow, Lichetenstein, Marcus, 2003). Specifically, this presentation will use the ASAP research team’s trial and documentation of solutions to inform future researchers’ decisions (i.e., regarding methodology, organization, grant-writing, and analysis) during the transition from development to efficacy trial.