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.

IF 5 3区医学 Q1 CLINICAL NEUROLOGY

Psychiatry and Clinical Neurosciences Pub Date : 2025-04-11 DOI:10.1111/pcn.13824

Jae Hyun Yoo, Enn Young Lee, Jung-Won Lee, Hahn Kim, Sung Ja Cho, Ran Ju, Hyun Jae Kim, Jung Yeon Moon, Tae Young Choi, Junho Lee, Changwon Jang, Seong Hee Park, Bum Joon Seok, Yoo-Sook Joung

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引用次数: 0

Abstract

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).

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手机应用游戏（NDTx-01）在提高自闭症谱系障碍或社交障碍青少年社交技能方面的有效性：一项随机对照试点试验。

目的：被诊断为自闭症谱系障碍（ASD）或社会沟通障碍（SCD）的青少年经历社会沟通困难。社会技能培训（SST）已被证明是有效的，尽管它的使用仍然受到限制，因为有限的可及性。这项多中心、平行、开放标签、评估者盲法、随机对照的试验评估了NDTx-01（一款整合SST的移动应用游戏）对10 - 18岁ASD或SCD患者的疗效。方法：39例符合入选标准的受试者随机分为两组。对照组接受常规治疗（TAU），干预组（INT + TAU）使用TAU + NDTx-01治疗10分钟，每周5次，持续6周。主要结果测量包括韩国Vineland适应行为量表ii的适应行为复合（ABC）的变化。次要测量包括社会反应量表-2 （SRS-2）得分、焦虑水平和养育压力。结果：INT + TAU组1名受试者撤回同意。38例患者留作分析。与TAU组比较(n = 19，男性18例；年龄（13.58±2.14岁），INT + TAU组(n = 19，男性16；年龄（13.42±2.36岁）6周后ABC有显著改善（INT + TAU 5.89±5.61 vs TAU 1.21±5.99）（P = 0.037）。此外，在SRS-2评分中，限制兴趣和重复行为（INT + TAU -9.11±10.26 vs TAU -2.89±7.13）显著降低（P = 0.037）。无不良事件报告。结论：基于手机游戏的SST在年轻ASD或SCD患者的适应功能方面显示出有效性。需要进一步的验证性研究和功率估计来验证NDTx-01的效果。临床试验注册信息：本随机对照研究已在韩国国家医学信息知识中心临床研究信息服务中心注册（注册号：KCT0009140， https://cris.nih.go.kr/cris/search/detailSearch.do?seq=26713&search_page=L）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Psychiatry and Clinical Neurosciences 医学-精神病学

CiteScore

7.40

自引率

4.20%

发文量

181

审稿时长

6-12 weeks

期刊介绍： PCN (Psychiatry and Clinical Neurosciences) Publication Frequency: Published 12 online issues a year by JSPN Content Categories: Review Articles Regular Articles Letters to the Editor Peer Review Process: All manuscripts undergo peer review by anonymous reviewers, an Editorial Board Member, and the Editor Publication Criteria: Manuscripts are accepted based on quality, originality, and significance to the readership Authors must confirm that the manuscript has not been published or submitted elsewhere and has been approved by each author