AVATA Cure Digital Therapeutics for Social Communication in Children With Autism Spectrum Disorder: A Pilot Clinical Trial.

Abstract

Objective: Autism spectrum disorder (ASD) is characterized by deficits in social interactions, reciprocal communication, and pragmatic language. Traditional therapeutics are effective but limited by economic, temporal, and spatial constraints. This pilot trial evaluated the effectiveness of AVATA Cure, a mobile-based digital therapeutic application, in improving the social communication skills of children with ASD.

Methods: Thirty-three children with ASD aged 1-7 years were enrolled, of whom 29 completed the study. Participants used AVATA Cure at home on a tablet device for at least 30 minutes per day, 4 days per week, for 8 weeks. The program included modules targeting joint attention, receptive and expressive pragmatics, and non-verbal communication. Social communication skills were assessed at baseline, 4 weeks, and 8 weeks using the Autism Diagnostic Observation Schedule-2 (ADOS-2); Sequenced Language Scale for Infants (SELSI) or Preschool Receptive-Expressive Language Scale (PRES); Social Communication Questionnaire (SCQ); and Korean Vineland Adaptive Behavior Scales 2nd edition (K-Vineland-II). The statistical analyses included complete case analysis with analysis of variance and Bonferroni correction.

Results: Significant improvements were observed in all measures. ADOS-2 reciprocal social interaction scores decreased significantly, indicating reduced impairment. SELSI/PRES pragmatic language scores increased significantly. SCQ scores decreased, and the K-Vineland-II subscales improved, reflecting enhanced adaptive functioning.

Conclusion: AVATA Cure demonstrated preliminary efficacy for enhancing social communication among children with ASD. Notable improvements across multiple assessments suggest its potential as a scalable, accessible, and cost-effective intervention that may complement existing therapies and provide early therapeutic benefits.