Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 14, 2024
Date Accepted: Aug 8, 2025
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Development of a Social Communication Intervention Application for Adolescents with ASD and SCD: Protocol for a Pilot Clinical Trial
ABSTRACT
Background:
Autism spectrum disorder (ASD) and social communication disorder (SCD) are characterized by deficits in social communication that hinder social adaptation, with limited pharmacologic options for therapy due to the absence of identified biomarkers.
Objective:
Recognizing the need for accessible and cost-effective interventions, we developed the digital therapeutic NDTx-01, integrating cognitive behavioral therapy principles, story-based interventions, and gamification elements.
Methods:
This study introduces a protocol for evaluating the efficacy and safety of NDTx-01 through a multicenter, prospective, randomized, assessor-blinded pilot trial involving adolescents aged 1018 years. Participant recruitment and enrollment will be executed in three major medical hospitals, where inter-reliability will be managed by the study team. Enrolled participants, divided into intervention and control groups, will undergo a 6-week intervention with NDTx-01 and usual care or maintain usual care, respectively. The intervention, implemented by NDTx-01, will be structured to last for 6 weeks, with sessions of approximately 10 minutes daily, 5 days a week. Following this, data analysis, including frequency analysis, descriptive statistical analysis, and tests for within-group and between-group differences, will be undertaken.
Results:
As of August 2024, we enrolled 39 patients, and this clinical trial has been successfully completed.
Conclusions:
Anticipated results, to be published in April 2024, aim to contribute crucial insights into the effectiveness of digital therapeutics as interventions for ASD and SCD in adolescents.
Citation
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Copyright
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