Effectiveness of a mobile application game (NDTx-01) in enhancing social communication skills in adolescents with autism spectrum disorder or social communication disorder: A randomized controlled pilot trial.

Aim: Adolescents diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) experience social communication difficulties. Social skills training (SST) for this population has proven effective, although its use remains restricted due to limited accessibility. This multicenter, parallel, open-label, assessor-blinded, randomized controlled pilot trial evaluated the efficacy of NDTx-01, a mobile application game integrating SST, in patients aged 10 to 18 years diagnosed with ASD or SCD.

Methods: A total of 39 participants fulfilled the eligibility criteria and were randomly assigned to two groups. While the control group received treatment as usual (TAU), the intervention group (INT + TAU) engaged with TAU plus NDTx-01 for 10 minutes, five times per week, for 6 weeks. The primary outcome measure included changes in the adaptive behavior composites (ABC) of the Korean Vineland Adaptive Behavior Scale-II. Secondary measures included Social Responsiveness Scale-2 (SRS-2) scores, anxiety levels, and parenting stress.

Results: One participant in the INT + TAU group withdrew consent. Thirty-eight patients remained for analysis. Compared with the TAU group (n = 19, 18 males; age, 13.58 ± 2.14 years), the INT + TAU group (n = 19, 16 males; age, 13.42 ± 2.36 years) exhibited significant improvements (INT + TAU 5.89 ± 5.61 vs TAU 1.21 ± 5.99) in the ABC (P = 0.037) after 6 weeks. Additionally, a significant reduction in restricted interests and repetitive behaviors (INT + TAU -9.11 ± 10.26 vs TAU -2.89 ± 7.13) in SRS-2 scores was found (P = 0.037). No adverse events were reported in participants.

Conclusion: The mobile game-based SST has demonstrated effectiveness in adaptive functioning in young patients with ASD or SCD. A further confirmatory study with power estimate is required to validate the effects of NDTx-01.

Clinical Trial Registration Information: This randomized controlled study was registered in Clinical Research Information Service, National Center for Medical Information and Knowledge, Republic of Korea (Registration Number: KCT0009140, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=26713&search_page=L).