Shared Reading Intervention for Children with Oral Clefts

针对唇裂儿童的共享阅读干预

• 批准号: 10880489
• 负责人: Brent Russell Collett
• 金额: $ 77.9万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10880489
• 关键词: Abbreviations; Address; Affect; Age; Appointment; Attention; Awareness; Behavior; Behavioral; Benchmarking; Books; Caregivers; Caring; Catchment Area; Cellular Phone; Characteristics; Child; Child Care; Child Language; Child Rearing; Clinic; Clinic Visits; Clinical; Congenital Abnormality; Consent; Control Groups; Development; Disparity; Educational Status; Enrollment; Ensure; Family; Frequencies; Geography; Health; Heterogeneity; Home; Infant; Intervention; Intervention Studies; Intervention Trial; Language; Latino; Linguistics; Live Birth; Los Angeles; Manuals; Measures; Mediating; Mediation; Monitor; Outcome; Parent-Child Relations; Parenting Education; Parents; Participant; Pathologist; Patients; Pediatric Hospitals; Persons; Phase; Population; Prevalence; Printing; Protocols documentation; Provider; Randomized; Randomized, Controlled Trials; Reading; Remote session; Research; Risk; Rural; Sampling; Secure; Speech; Target Populations; Testing; Text Messaging; Training; Training Activity; Translating; Translations; Treatment Efficacy; Video Recording; Videoconferencing; Visit; Vulnerable Populations; craniofacial; effective intervention; efficacy testing; group intervention; high risk; improved; innovation; intervention delivery; literacy; novel; operation; oral cleft; palate repair; participant enrollment; patient population; peer; pilot test; programs; recruit; remote delivery; remote intervention; rural area; skills; smartphone application; social; telecoaching

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.

项目概要 与同龄人相比，患有唇裂的儿童出现语言和识字能力缺陷的风险更高。 然而，迄今为止，尚未关注可能抵消这些风险的干预措施。这项研究将 第一个开发和测试共享阅读干预措施以促进年轻人的语言和新兴读写能力 有口腔裂的儿童。我们将根据该人群的需求定制干预措施，确保该计划 可以与定期颅面预约配合并使用创新的远程指导来进行 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，面对面的课程将与儿童的常规课程相协调 颅面护理。在两次访问之间，护理人员将使用智能手机发送共享的视频记录 阅读互动，供干预者回顾并提供鼓励和指导。该研究将是 在 3 个主要中心的颅面诊所进行，为多样化和互补的患者提供服务 人群：西雅图儿童医院、全国儿童医院和洛杉矶儿童医院 安吉利斯。我们将翻译和审查所有材料，以确保英语和语言的文化和语言适宜性。 讲西班牙语的家庭。在研究的规划阶段（UG3），我们将完成我们的治疗并 研究方案（目标 1）。我们将招募30名16至20个月大的唇裂儿童作为样本 及其护理人员对干预措施进行简短的试点测试。这将使我们能够建立干预措施 我们的目标人群的可行性/可接受性，并建立跨中心的治疗保真度（目标 2）。这 试点项目还将展示干预措施是否涉及拟议的行为目标（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 名唇裂儿童及其家长进行干预。我们将在上颚修复后招募参与者 （16-20 个月大），随机分配一半接受干预，另一半接受纯信息干预 对照组。干预将包括 3 场现场会议和 12 场远程会议，会议地点为 基线至 36 个月。 RCT 的目标包括 (1) 检验干预改善的假设 儿童 36 个月大时的语言和读写能力结果； (2a) 检验干预的假设 改善看护者的共同阅读行为，并且 (2b) 儿童成果的改善是通过 照顾者共同阅读行为的变化； (3) 根据以下因素检查结果的异质性： 人口统计学、临床和干预特征。这将是第一项检验干预措施的研究 解决口腔唇裂儿童中观察到的语言和读写能力缺陷。除了改善护理 患有唇裂的儿童，用于将干预范围扩大到农村和地理区域的策略 多样化的家庭将对许多其他儿童群体的干预措施产生影响。