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评估节奏与语言训练严肃游戏联合言语治疗对比单纯言语治疗对诵读困难儿童的非劣效性:一项研究者设盲的随机对照试验方案

Assessing the Noninferiority of a Rhythm and Language Training Serious Game Combined With Speech Therapy Versus Speech Therapy Care for Children With Dyslexia: Protocol for an Investigator-Blinded Randomized Controlled Trial.

作者信息

Grossard Charline, Descamps Mélanie, Cadoni Sara, Pellerin Hugues, Vonthron François, Xavier Jean, Falissard Bruno, Cohen David

机构信息

Department of Child and Adolescent Psychiatry, Pitié-Salpêtrière Hospital, Paris, France.

Poppins, Paris, France.

出版信息

JMIR Res Protoc. 2025 Apr 3;14:e71326. doi: 10.2196/71326.

DOI:10.2196/71326
PMID:40179385
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12006771/
Abstract

BACKGROUND

Specific learning disorder (SLD) of reading skills impacts approximately 7% of children. Speech and reading therapy is currently the gold-standard intervention for improving children's reading abilities. However, intensive interventions are difficult to implement. Recently, numerous studies have investigated the interest of game- and home-based training approaches to enhance children's motivation and facilitate intensive learning activities in home settings. The serious game Poppins Clinical integrates rhythm and specific written language exercises to improve reading skills in children with SLD.

OBJECTIVE

This study aimed to assess the noninferiority of Poppins Clinical combined with a reading specialist session once every 2 weeks versus a reading specialist session every week, on the reading skills of children with SLD.

METHODS

A total of 306 children with dyslexia will be recruited for this study and randomly assigned to either the experimental or control group. Children in the experimental group will use the serious game Poppins Clinical at home for 20 minutes, 5 days a week, and attend 1 reading therapy session every 2 weeks. The control group will participate in one reading therapy session per week. Poppins Clinical combines rhythm and language exercises integrated into an engaging game designed to maintain user motivation. We will use a noninferiority paradigm to assess the clinical impact of both interventions in terms of reading accuracy, reading speed, and reading comprehension. We will also investigate the evolution of phonological and visual-attentional skills. However, we will explore the impact of the protocol on parental stress and children's perception of their difficulties. Finally, we will also assess the cost of medical care and the impact of introducing the serious game Poppins Clinical on reading therapy. To facilitate recruitment and ensure the representativeness of our sample, the evaluation of the children will be conducted via videoconference using standardized tests that have been adapted for videoconference administration.

RESULTS

Patient recruitment is expected to start in December 2024, with study completion by the end of August 2025.

CONCLUSIONS

This study should allow us to assess the interest in using the serious game Poppins Clinical in addition to reading therapy to improve reading abilities in children with SLD.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06592911; https://clinicaltrials.gov/study/NCT06592911.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71326.

摘要

背景

阅读技能的特定学习障碍(SLD)影响约7%的儿童。言语和阅读疗法是目前提高儿童阅读能力的金标准干预措施。然而,强化干预难以实施。最近,许多研究调查了基于游戏和家庭训练方法的趣味性,以提高儿童的积极性并促进在家中进行强化学习活动。严肃游戏《波平斯临床版》将节奏和特定的书面语言练习相结合,以提高患有SLD儿童的阅读技能。

目的

本研究旨在评估《波平斯临床版》结合每两周一次的阅读专家课程与每周一次的阅读专家课程相比,对患有SLD儿童阅读技能的非劣效性。

方法

本研究共招募306名诵读困难儿童,并随机分配到实验组或对照组。实验组的儿童将在家中使用严肃游戏《波平斯临床版》20分钟,每周5天,并每两周参加1次阅读治疗课程。对照组将每周参加1次阅读治疗课程。《波平斯临床版》将节奏和语言练习融入一个引人入胜的游戏中,旨在保持用户的积极性。我们将使用非劣效性范式,从阅读准确性、阅读速度和阅读理解方面评估两种干预措施的临床影响。我们还将调查语音和视觉注意力技能的演变。然而,我们将探讨该方案对父母压力和儿童对自身困难认知的影响。最后,我们还将评估医疗护理成本以及引入严肃游戏《波平斯临床版》对阅读治疗的影响。为便于招募并确保样本的代表性,将通过视频会议使用已针对视频会议管理进行调整的标准化测试对儿童进行评估。

结果

预计患者招募将于2024年12月开始,研究于2025年8月底完成。

结论

本研究应能让我们评估除阅读治疗外,使用严肃游戏《波平斯临床版》对提高患有SLD儿童阅读能力的价值。

试验注册

ClinicalTrials.gov NCT06592911;https://clinicaltrials.gov/study/NCT06592911。

国际注册报告识别码(IRRID):DERR1-10.2196/71326。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/610f/12006771/b88e56360d69/resprot_v14i1e71326_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/610f/12006771/08ad5fce9102/resprot_v14i1e71326_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/610f/12006771/b88e56360d69/resprot_v14i1e71326_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/610f/12006771/08ad5fce9102/resprot_v14i1e71326_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/610f/12006771/b88e56360d69/resprot_v14i1e71326_fig2.jpg

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