背景:腭裂患儿,有或没有唇裂(CP±L),与没有裂痕的儿童相比,平均表现出语言延迟。解决这些差距的干预措施很少。在这项多中心研究中,带切口的幼儿图书共享(BOOST),我们将测试一个遥控器,以父母为中心的干预促进CP±L儿童的语言发育
目的:本研究将检验两个主要假设。首先,与接受标准护理(SOC)的儿童相比,随机接受BOOST的幼儿将表现出更好的语言结果。第二,我们假设BOOST程序对语言结果的影响是由亲子阅读互动的频率和质量介导的。
方法:本研究是一项比较BOOST组与SOC比较组的随机对照试验。我们将招募N=320名年龄在24-32个月的英语和/或西班牙语儿童,其CP±L(每组n=160)。两组都将收到儿童读物,父母将使用为这项研究开发的智能手机应用程序记录并上传自己与孩子一起阅读书籍的视频。父母还将完成调查,询问他们是否在每周随机选择的五天给孩子读书。此外,BOOST组将通过Zoom参与3次远程对话书籍共享干预会话。我们将编写书籍共享视频,以评估父母的目标技能使用情况和孩子的表达语言。研究结束评估将包括儿童语言结果的衡量标准(例如,临床医生管理的措施,父报告,和自然主义儿童语言样本)。
结果:报名于2024年4月开始,并将持续到2028年4月左右。
结论:BOOST研究将解决文献中关于改善CP±L儿童语言的干预措施的关键空白。结果将为患有口腔裂痕的幼儿提供护理,并对其他人群具有潜在的应用价值。
BACKGROUND: Children with cleft palate, with or without cleft lip (CP±L), exhibit language delays on average compared to children without clefts. Interventions to address these disparities are scarce. In this multi-center study, Book Sharing for Toddlers with Clefts (BOOST), we will test a remote, parent-focused intervention to promote language development in children with CP±L.
OBJECTIVE: The
study will test two primary hypotheses. First, toddlers randomized to BOOST will exhibit better language outcomes than children receiving standard-of-care (SOC). Second, we hypothesize that the BOOST program\'s effect on language outcomes is mediated by the frequency and quality of parent-child reading interactions.
METHODS: The
study is a randomized-controlled
trial comparing the BOOST group to a SOC comparison group. We will enroll N = 320 English and/or Spanish-speaking children ages 24-32 months with isolated CP±L (n = 160 per group). Both groups will receive children\'s books, and parents will record and upload videos of themselves reading the books with their children using a smartphone app developed for the
study. Parents will also complete surveys asking whether they read to their children on five randomly selected days each week. In addition, the BOOST group will participate in 3 remote dialogic book-sharing intervention sessions via Zoom. We will code book-sharing videos to assess parents\' target skill usage and children\'s expressive language. End-of-
study assessments will include measures of child language outcomes (e.g., clinician-administered measures, parent reports, and naturalistic child language samples).
RESULTS: Enrollment began in April 2024 and will continue through approximately April 2028.
CONCLUSIONS: The BOOST
study will address a critical gap in the literature on interventions to improve language in children with CP±L. The results will inform the care for toddlers with oral clefts and have potential applications for other populations.