Applying a User-Centered Design Framework to Develop a Remote Research Assessment Protocol for a Randomized Clinical Trial for Toddlers with Early Autism Characteristics.

COVID-19 required many research teams to shift from in-person to remote assessments, which posed both procedural and theoretical challenges. While research has explored the utility of remote assessments for autism diagnosis from the perspective of families and clinicians, less is known about their application in clinical trials. This paper describes the development of a remote research assessment protocol for a randomized clinical trial focusing on the implementation of reciprocal imitation teaching (RIT) with toddlers in Part C early intervention. This project spans two phases. For Phase 1, our team developed and documented a series of steps utilizing user-centered design (UCD) strategies (e.g., recruiting potential users, creating a prototype, engaging in iterative development) for the purpose of redesigning an assessment protocol for a remote environment. For Phase 2, we examined preliminary outcomes of the redesign process. Primary end users (assessors) rated post-redesign usability and acceptability, while acceptability was examined using attrition data from secondary end users (family participants). Preliminary fidelity of implementation was also examined. The iterative redesign process allowed the research team to refine aspects of the assessment that ultimately led to promising preliminary ratings of usability, acceptability, and feasibility, as well as high fidelity. Preliminary data suggest that the redesigned assessment appears to be an acceptable, feasible, and usable tool for autism clinical trial research and that assessors can use it with fidelity. Further research is needed to examine the reliability and validity of the assessment, as well as implementation characteristics on a larger scale.

A Taxonomy of Reported Harms in Pediatric Autism Spectrum Disorder Screening: Provider and Parent Perspectives.

The U.S. Preventive Services Task Force (USPSTF) report on screening for Autism Spectrum Disorder (ASD) highlighted the need for research that examines the harms potentially associated with screening so as to assess the overall net benefit of universal screening. In response, this study engages qualitative, semi-structured interviews to generate a taxonomy outlining potential harms reported by parents and providers (pediatricians and Early Intervention providers) with experience in screening young children for ASD. Potential harms emerged including: physical, psychological, social, logistical/financial, opportunity cost, attrition, and exacerbation of non-targeted disparities. Respondents reported harms being experienced by the toddlers, parents, and providers. The harms reported highlight opportunities for providers to offer resources that mitigate the potential for these unintended consequences.

Multi-method process maps: An interdisciplinary approach to investigate ad hoc modifications in protocol-driven interventions.

INTRODUCTION: Implementation scientists increasingly recognize that the process of implementation is dynamic, leading to ad hoc modifications that may challenge fidelity in protocol-driven interventions. However, limited attention to ad hoc modifications impairs investigators' ability to develop evidence-based hypotheses about how such modifications may impact intervention effectiveness and cost. We propose a multi-method process map methodology to facilitate the systematic data collection necessary to characterize ad hoc modifications that may impact primary intervention outcomes. METHODS: We employ process maps (drawn from systems science), as well as focus groups and semi-structured interviews (drawn from social sciences) to investigate ad hoc modifications. Focus groups are conducted with the protocol's developers and/or planners (the implementation team) to characterize the protocol "as envisioned," while interviews conducted with frontline administrators characterize the process "as realized in practice." Process maps with both samples are used to identify when modifications occurred across a protocol-driven intervention. A case study investigating a multistage screening protocol for autism spectrum disorders (ASD) is presented to illustrate application and utility of the multi-method process maps. RESULTS: In this case study, frontline administrators reported ad hoc modifications that potentially influenced the primary study outcome (e.g., time to ASD diagnosis). Ad hoc modifications occurred to accommodate (1) whether providers and/or parents were concerned about ASD, (2) perceptions of parental readiness to discuss ASD, and (3) perceptions of family service delivery needs and priorities. CONCLUSION: Investigation of ad hoc modifications on primary outcomes offers new opportunities to develop empirically based adaptive interventions. Routine reporting standards are critical to provide full transparency when studying ad hoc modifications.