Sensitive, standardized, reliable measures of outcomes for clinical trials attempting to change behavior and function in children and adults with autism spectrum disorder (ASD) have been extremely limited to date. Previous clinical trials have often relied on a single measure to quantify change, determined change in one domain or context (i.e., language or solely parent report or assessments only in the clinic), or used an approach measure with limited capability for replication, thus reducing the scope of the research.

Adequate measures of targeted behaviors expected to change, associations with neurophysiological and biomedical methods that allow inferences about mediating and moderating factors, and appropriate expectations for biases and placebo effects are critical for developing comprehensive and reliable protocols. Outcomes in clinical trials that combine multiple domains to measure behavior, as well as multiple contexts for measure collection, will ensure the greatest success for capturing change in individuals with ASD. In addition, clinicians and researchers need to be realistic about the limits of how much effort a parent of a child with ASD is able to expend during the course of a multi-week clinical trial and to make thoughtful decisions about how to use this effort.

In the current project, Catherine Lord and Rebecca Jones plan to develop behavioral and neurophysiological measures sensitive to change in response to brief treatments of individuals with ASD and to determine an integrated clinic, online and home protocol that is cost-effective, unobtrusive, and maximizes participant retention. Multiple sources of data (including biophysiological, behavior, language, parent report, clinical assessment) across multiple contexts (i.e., home, clinic, smartphone/computer) will be used to capture the complexity and nuances of the behavioral profile of an individual with ASD. This design is expected to enable the refinement of a research protocol that can ultimately be repeated by other research groups to measure change in individuals undergoing medical and behavioral interventions.