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面对面及通过远程医疗服务进行视觉-听觉干预治疗残留语音障碍的非劣效性试验(VISIT)方案

Protocol for visual-acoustic intervention with service delivery in-person and via telepractice (VISIT) non-inferiority trial for residual speech sound disorder.

作者信息

McAllister Tara, Preston Jonathan L, Hitchcock Elaine R, Benway Nina R, Hill Jennifer

机构信息

Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Room 602, New York, New York, 10012, USA.

Department of Communication Sciences and Disorders, Syracuse University, Syracuse, New York, USA.

出版信息

BMC Pediatr. 2025 Jan 27;25(1):65. doi: 10.1186/s12887-024-05364-z.

Abstract

BACKGROUND

Residual speech sound disorder (RSSD) is a high-prevalence condition that negatively impacts social and academic participation. Telepractice service delivery has the potential to expand access to technology-enhanced intervention methods that can help remediate RSSD, but it is not known whether remote service delivery is associated with a reduction in the efficacy of these methods. This project will systematically measure the outcomes of visual-acoustic biofeedback intervention when delivered in-person or online.

METHODS/DESIGN: This project, Visual-acoustic Intervention with Service delivery In-person and via Telepractice (VISIT), aims to treat 76 children in a parallel randomized controlled clinical trial in which children with RSSD will receive visual-acoustic biofeedback treatment either in person or via telepractice. Eligible children will be speakers of American English aged 9-17 years who exhibit RSSD affecting /ɹ/ but otherwise show cognitive-linguistic and hearing abilities within the typical range. All participants will receive twenty sessions of visual-acoustic biofeedback; they will be randomized, with stratification by pre-treatment speech production ability and site, to complete their treatment sessions either in the laboratory setting or at home via telepractice. For the primary outcome measure, blinded listeners will evaluate changes in the perceived accuracy of /ɹ/ production after the end of treatment.

DISCUSSION

By comparing outcomes in children randomized to receive a standard course of biofeedback treatment either via telepractice or in-person, this study will provide evidence-based guidance for clinicians seeking flexible service delivery options for a challenging and prevalent condition.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT06517225, 07/23/2024. URL: https://clinicaltrials.gov/study/NCT06517225 .

摘要

背景

残留语音障碍(RSSD)是一种高发性疾病,对社交和学业参与产生负面影响。远程医疗服务提供了扩大获取技术增强型干预方法的机会,这些方法有助于治疗RSSD,但尚不清楚远程服务提供是否会降低这些方法的疗效。本项目将系统地测量面对面或在线提供视觉声学生物反馈干预的效果。

方法/设计:本项目,即面对面和通过远程医疗进行视觉声学干预(VISIT),旨在在一项平行随机对照临床试验中治疗76名儿童,其中患有RSSD的儿童将接受面对面或通过远程医疗的视觉声学生物反馈治疗。符合条件的儿童将是年龄在9至17岁之间、以美式英语为母语、患有影响/ɹ/的RSSD但在认知语言和听力能力方面处于典型范围内的儿童。所有参与者将接受20次视觉声学生物反馈治疗;他们将根据治疗前的语音产生能力和地点进行分层随机分组,在实验室环境中或通过远程医疗在家中完成治疗课程。对于主要结局指标,不知情的听众将在治疗结束后评估/ɹ/发音的感知准确性变化。

讨论

通过比较随机接受远程医疗或面对面标准生物反馈治疗课程的儿童的结局,本研究将为临床医生提供循证指导,帮助他们为这一具有挑战性的高发性疾病寻求灵活的服务提供选择。

试验注册

ClinicalTrials.gov标识符NCT06517225,2024年7月23日。网址:https://clinicaltrials.gov/study/NCT06517225

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99b5/11771047/9ef1cba3b3f3/12887_2024_5364_Fig1_HTML.jpg

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