Shared Reading Intervention for Children with Oral Clefts

项目总结 与同龄人相比，患有口裂的儿童在语言和识字方面存在更大的缺陷风险。 然而，到目前为止，人们还没有注意到可能抵消这些风险的干预措施。这项研究将是 第一个开发和测试共享阅读干预，以促进年轻人的语言和新出现的读写能力 患有口裂的儿童。我们将根据这些人口的需求量身定做干预措施，确保该计划 可与常规头面部预约和使用创新的远程教练相协调 促进传统上在研究中代表性不足的家庭参与的战略 (例如，居住在农村地区的家庭)。具体来说，面对面的会议将与儿童定期会议协调 头面部护理。在两次探视之间，照顾者将使用他们的智能手机发送共享的视频记录 阅读互动，以供干预者回顾并提供鼓励和指导。这项研究将是 在三个主要中心的头面部诊所进行，为不同和互补的患者提供服务 人口：西雅图儿童医院、全国儿童医院和洛杉矶儿童医院 安吉。我们将翻译和审查所有材料，以确保英语和英语在文化和语言上的适当性 说西班牙语的家庭。在研究的规划阶段(UG3)，我们将最终确定我们的治疗方法和 研究方案(目标1)。我们将招募30名16至20个月大的口腔裂儿童作为样本。 和他们的照顾者进行一次简短的干预试验。这将使我们能够建立干预 在我们的目标人群中的可行性/可接受性，并建立跨中心的治疗保真度(目标2)。这 试点还将演示干预是否涉及建议的行为目标(即，父母的阅读 行为)(目标3)。在实施阶段(UH3)，我们将进行随机对照试验 对320例唇裂患儿及其家长进行干预。我们将招募腭部修复后的参与者 (16-20个月)，随机一半接受干预，另一半只接受信息干预 对照组。干预将包括3次面对面会议和12次远程会议 从基线到36个月。随机对照试验的目的包括(1)检验干预改善的假设 儿童36个月时的语言和识字结果；(2a)检验干预的假设 改善照顾者的共享阅读行为和(2b)儿童结果的改善是通过 照顾者共享阅读行为的变化；以及(3)基于以下方面检查结果的异质性 人口学、临床和干预特征。这将是第一个检查干预措施的研究 解决在口裂儿童中观察到的语言和识字缺陷。除了改善对患者的护理 用于将干预范围扩大到农村和地理位置的口裂儿童 不同的家庭将对许多其他儿童群体的干预提供产生影响。

PROJECT SUMMARY Children with oral clefts are at increased risk for deficits in language and literacy compared to their peers. However, to date no attention has been given to interventions that might offset these risks. This study will be the first to develop and test a shared reading intervention to promote language and emergent literacy for young children with oral clefts. We will tailor the intervention to the needs of this population, ensuring that the program can be delivered in coordination with regular craniofacial appointments and using innovative remote coaching strategies to facilitate engagement among families who have traditionally been under-represented in research (e.g., families living in rural areas). Specifically, in-person sessions will be coordinated with children’s regular craniofacial care. Between visits, caregivers will use their smartphones to send video recordings of shared reading interactions for interventionists to review and provide encouragement and coaching. The study will be conducted in craniofacial clinics at 3 major centers, which serve diverse and complementary patient populations: Seattle Children’s Hospital, Nationwide Children’s Hospital, and Children’s Hospital of Los Angeles. We will translate and review all materials for cultural and linguistic appropriateness for English and Spanish-speaking families. In the planning phase (UG3) of the study, we will finalize our treatment and research protocols (Aim 1). We will recruit a sample of 30 children with oral clefts ages 16 to 20-months old and their caregivers for an abbreviated pilot test of the intervention. This will allow us to establish intervention feasibility/acceptability in our target population, and to establish treatment fidelity across centers (Aim 2). This pilot will also demonstrate whether the intervention engages proposed behavioral targets (i.e., parents’ reading behaviors) (Aim 3). In the implementation phase (UH3), we will conduct a randomized controlled trial of the intervention with 320 children with oral clefts and their parents. We will enroll participants after palate repair (ages 16-20 months) and randomize half to receive the intervention and the other half to an information -only control group. The intervention will consist of 3 in person sessions and 12 remote sessions delivered from baseline through age 36-months. Aims for the RCT include (1) Test the hypothesis that intervention improves children’s language and literacy outcomes at age 36 months; (2a) Test the hypothesis that intervention improves caregivers’ shared reading behaviors and (2b) that improvements in child outcomes are mediated by changes in caregivers’ shared reading behaviors; and (3) Examine heterogeneity in outcomes based on demographic, clinical, and intervention characteristics. This will be the first study to examine an intervention to address language and literacy deficits observed in children with oral clefts. In addition to improving care for children with oral clefts, the strategies used to extend the reach of intervention to rural and geographically diverse families will have implications for intervention delivery in many other child populations.