Trial reportPsychiatry and clinical neurosciences2025
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.
Trial report in Psychiatry and clinical neurosciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
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Authors and funding
14 authors.
Funding
Abstract
aimAdolescents 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.
methodsA 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.
resultsOne 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.
conclusionThe 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).
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