Utility of Outcome Measures in ASD – Are We Measuring What We Think We Are Measuring?

Background: While many different outcome measures are available to measure the core and associated symptoms of Autism Spectrum Disorder (ASD), traditionally these scales have been utilized to facilitate diagnosis, or to measure change over longer time periods. While there are both clinician (observational and interview) and caregiver/parent measures available, most frequently studies utilize parent/caregiver measures due to their extensive knowledge of the child or adult with ASD. The very nature of early clinical drug development requires that a measure that meets several criteria: 1) comprehensively measure the core symptoms of autism, and ideally some associated symptoms; 2) is responsive to change over short time periods (ie, 3-6 months) by measuring aspects of behavior that might be expected to change with treatment; 3) is understandable from the first administration, without explanation or support from the clinician or study staff to avoid bias; 4) and avoids burnout over time by being brief and repeatable.

Objectives and Methods: This presentation will focus on the results of a recently completed caregiver cognitive debriefing study (N=50 parents/caregivers) with a validated measure of core and associated ASD symptoms, the Autism Behavior Inventory (Bangerter et al, 2017).

Results: The ABI is a part of the JAKE ® (Janssen Autism Knowledge Engine) System, a set of tools and technologies designed to optimize clinical trials for ASD. While the vast majority of comments from caregivers regarding the ABI reflected their clear comprehension of the items and concepts, small changes to item wording and examples resulted in improved acceptance and understanding and reduced scale length.

Conclusions: Examples of caregiver feedback and impact on utility of the ABI for clinical trials will be discussed.