Identification of the Minimal Clinically Important Difference (MCID) for Childhood Autism Rating Scale Second Edition (CARS2) in children with ASD

Purpose: In clinical trials, treatment efficacy is commonly assessed by comparing control and treatment groups. However, in large samples, even small and clinically trivial differences may achieve statistical significance. Accordingly, the Minimal Clinically Important Difference (MCID) is used as a threshold to determine whether statistically-significant effects are also clinically meaningful to patients. The objective of this study was to estimate the MCID for the Childhood Autism Rating Scale Second-Edition (CARS2) using the Patient Impression of Change (PIC) as an external anchor. Methods: Single-item PICs are not well suited to characterizing improvement in a multifaceted disorder such as ASD. Accordingly, the 77-item Autism Treatment Evaluation Checklist (ATEC) was used as a multi-item PIC. CARS2 and ATEC were administered concurrently to 62 children with ASD, aged 1.8-7.9 years, with assessments conducted six months apart. Results: The correlation between changes in CARS2 and ATEC total scores was 0.41-0.44 (p<0.0001), supporting the use of ATEC as an anchor measure. Two anchor-based methods yielded MCIDs of 2.39-2.82 CARS2 points. Two distribution-based methods produced MCIDs of 1.33-3.32. Conclusions: Taken together, these approaches suggest that a between-group difference of 2.6 CARS2 points (the midpoint of the anchor-based estimates) may serve as the MCID in children with ASD.