Abstract
<title>Abstract</title> <p>Background To observe the efficacy of the Early Start Denver Model (ESDM) combined with digital therapy in treating children with Autism Spectrum Disorder (ASD). Methods Children aged 2–8 years diagnosed with ASD were assigned to either the ESDM group (n = 58) or the ESDM + DTx group (n = 35), based on parental preference. With the latter group receiving DTx, both groups received ESDM intervention for 3 months. Efficacy was assessed before and after treatment using the Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), Autism Treatment Evaluation Checklist (ATEC), and Griffiths Development Scales-Chinese (GDS-C). Results Both groups improved significantly. Moreover, Between-group analysis of covariance revealed that the ESDM + DTx group exhibited superior performance to the ESDM group in terms of performance on GDS-C, the language subscales of ABC, as well as total score on the CARS. Additionally, the ESDM + DTx group showed better outcomes in physical/ health/ behavior, expressive language, and cognitive/awareness and the total score of ATEC. Conclusion The combination of ESDM and DTx significantly improved core symptoms and developmental outcomes in ASD children compared to ESDM alone, suggesting integrating digital therapeutics with early intervention can enhance treatment effectiveness for ASD children. Trial registration: This study was approved by the Ethics Committee of the First Hospital of Jilin University (Approval No. 25K071-001) and was clinically registered at March 24th, 2025 (ChiCTR2500099406).</p>