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.
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。