Collett Brent R, Gallagher Emily R, Johns Alexis L, Trevino Cindy O, Leroux Brian G, Shic Frederick, Crerand Canice E, Baylis Adriane L, Cummings Caitlin A, Santillan Lupita
Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, Washington, United States of America.
Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, United States of America.
PLoS One. 2024 Jun 13;19(6):e0304630. doi: 10.1371/journal.pone.0304630. eCollection 2024.
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.
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.
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).
Enrollment began in April 2024 and will continue through approximately April 2028.
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.
患有腭裂（无论有无唇裂，即CP±L）的儿童与无腭裂儿童相比，平均存在语言发育迟缓的情况。针对这些差异的干预措施很少。在这项多中心研究“腭裂幼儿图书分享（BOOST）”中，我们将测试一种以家长为重点的远程干预措施，以促进CP±L儿童的语言发展。
该研究将测试两个主要假设。第一，随机分配到BOOST组的幼儿在语言方面的表现将优于接受标准护理（SOC）的儿童。第二，我们假设BOOST项目对语言结果的影响是通过亲子阅读互动的频率和质量来介导的。
该研究是一项随机对照试验，将BOOST组与SOC对照组进行比较。我们将招募N = 320名年龄在24 - 32个月、讲英语和/或西班牙语、患有单纯CP±L的儿童（每组n = 160名）。两组都将收到儿童书籍，家长将使用为该研究开发的智能手机应用程序录制并上传他们与孩子一起读书的视频。家长还将完成调查问卷，询问他们是否在每周随机选择的五天里给孩子读书。此外，BOOST组将通过Zoom参加3次远程对话式图书分享干预课程。我们将对图书分享视频进行编码，以评估家长目标技能的使用情况和儿童的表达性语言。研究结束时的评估将包括儿童语言结果的测量（例如，临床医生实施的测量、家长报告和自然情境下的儿童语言样本）。
招募工作于2024年4月开始，将持续到大约2028年4月。
BOOST研究将填补关于改善CP±L儿童语言的干预措施的文献中的一个关键空白。研究结果将为腭裂幼儿的护理提供参考，并可能应用于其他人群。
