Abstract：
BACKGROUND: Children who are deaf or hard-of-hearing (DHH) are at risk for speech and language delay. Language outcomes are worse in DHH children from lower socioeconomic backgrounds, due in part to disparities in access to specialised speech-language therapy. Teletherapy may help improve access to this specialised care and close this language gap. Inclusion of diverse DHH children in prospective randomised clinical trials has been challenging but is necessary to address disparities and pursue hearing health equity. Stakeholder input regarding decisions on study design elements, including comparator groups, masking, assessments and compensation, is necessary to design inclusive studies. We have designed an inclusive, equitable comparativeness effectiveness trial to address disparities in paediatric hearing health. The specific aims of the study are to determine the effect of access to and utilisation of speech-language teletherapy in addressing language disparities in low-income children who are DHH.
METHODS: After stakeholder input and pilot data collection, we designed a randomised clinical trial and concurrent longitudinal cohort trial to be conducted at four tertiary children\'s hospitals in the USA. Participants will include 210 DHH children aged 0-27 months. 140 of these children will be from lower income households, who will be randomised 1:1 to receive usual care versus usual care plus access to supplemental speech-language teletherapy. 70 children from higher income households will be simultaneously recruited as a comparison cohort. Primary outcome measure will be the Preschool Language Scales Auditory Comprehension subscale standard score, with additional speech, language, hearing and quality of life validated measures as secondary outcomes.
BACKGROUND: This study was approved by the Institutional Review Boards of the participating sites: the University of California, San Francisco (19-28356), Rady Children\'s Hospital (804651) and Seattle Children\'s Hospital (STUDY00003750). Parents of enrolled children will provide written informed consent for their child\'s participation. Professional and parent stakeholder groups that have been involved throughout the study design will facilitate dissemination and implementation of study findings via publication and through national and regional organisations.
BACKGROUND: NCT04928209.
METHODS: After stakeholder input and pilot data collection, we designed a randomised clinical trial and concurrent longitudinal cohort trial to be conducted at four tertiary children\'s hospitals in the USA. Participants will include 210 DHH children aged 0-27 months. 140 of these children will be from lower income households, who will be randomised 1:1 to receive usual care versus usual care plus access to supplemental speech-language teletherapy. 70 children from higher income households will be simultaneously recruited as a comparison cohort. Primary outcome measure will be the Preschool Language Scales Auditory Comprehension subscale standard score, with additional speech, language, hearing and quality of life validated measures as secondary outcomes.
BACKGROUND: This study was approved by the Institutional Review Boards of the participating sites: the University of California, San Francisco (19-28356), Rady Children\'s Hospital (804651) and Seattle Children\'s Hospital (STUDY00003750). Parents of enrolled children will provide written informed consent for their child\'s participation. Professional and parent stakeholder groups that have been involved throughout the study design will facilitate dissemination and implementation of study findings via publication and through national and regional organisations.
BACKGROUND: NCT04928209.
摘要：
背景：失聪或听力困难（DHH）的儿童有言语和语言延迟的风险。来自较低社会经济背景的DHH儿童的语言结果更差，部分原因是在获得专门的言语语言治疗方面存在差异。远程治疗可能有助于改善获得这种专业护理的机会，并缩小这种语言差距。将不同的DHH儿童纳入前瞻性随机临床试验一直具有挑战性，但对于解决差异和追求听力健康公平是必要的。利益相关者关于研究设计元素决策的输入，包括比较组，掩蔽,评估和补偿，设计包容性研究是必要的。我们设计了一个包容性的，解决儿科听力健康差异的公平比较有效性试验。该研究的具体目的是确定获得和利用言语远程治疗在解决DHH低收入儿童的语言差异方面的效果。
方法：在利益相关者输入和试点数据收集之后，我们设计了一项随机临床试验和并行纵向队列试验,在美国4家三级儿童医院进行.参与者将包括210名0-27个月的DHH儿童。其中140个孩子将来自低收入家庭，他们将被随机分配1:1接受常规治疗，而不是常规治疗，并获得补充的言语语言远程治疗。将同时招募70名来自高收入家庭的儿童作为比较队列。主要结果测量将是学前语言量表听觉理解子量表标准分数，加上额外的演讲，语言,听力和生活质量验证指标作为次要结局.
背景：这项研究得到了参与研究的机构审查委员会的批准：加州大学，旧金山（19-28356）拉迪儿童医院（804651）和西雅图儿童医院（STUDY00003750）。注册儿童的父母将为他们的孩子的参与提供书面知情同意书。参与整个研究设计的专业和家长利益相关者团体将通过出版物以及国家和区域组织促进研究结果的传播和实施。
背景：NCT04928209。
方法：在利益相关者输入和试点数据收集之后，我们设计了一项随机临床试验和并行纵向队列试验,在美国4家三级儿童医院进行.参与者将包括210名0-27个月的DHH儿童。其中140个孩子将来自低收入家庭，他们将被随机分配1:1接受常规治疗，而不是常规治疗，并获得补充的言语语言远程治疗。将同时招募70名来自高收入家庭的儿童作为比较队列。主要结果测量将是学前语言量表听觉理解子量表标准分数，加上额外的演讲，语言,听力和生活质量验证指标作为次要结局.
背景：这项研究得到了参与研究的机构审查委员会的批准：加州大学，旧金山（19-28356）拉迪儿童医院（804651）和西雅图儿童医院（STUDY00003750）。注册儿童的父母将为他们的孩子的参与提供书面知情同意书。参与整个研究设计的专业和家长利益相关者团体将通过出版物以及国家和区域组织促进研究结果的传播和实施。
背景：NCT04928209。
