Shared Reading Intervention for Children with Oral Clefts

针对唇裂儿童的共享阅读干预

• 批准号: 10487408
• 负责人: Brent Russell Collett
• 金额: $ 32.01万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10487408
• 关键词: Address; Affect; Age; Appointment; Attention; Awareness; Behavior; Behavioral; Benchmarking; Books; Caregivers; Caring; Catchment Area; Cellular Phone; Characteristics; Child; Child Care; Child Language; Clinic; Clinic Visits; Clinical; Congenital Abnormality; Consent; Control Groups; Development; Educational Background; Enrollment; Ensure; Family; Frequencies; Geography; Glare; Health; Heterogeneity; Home; Infant; Intervention; Intervention Studies; Intervention Trial; Language; Latino; Linguistics; Live Birth; Los Angeles; Manuals; Measures; Mediating; Mediation; Monitor; Oral; Outcome; Parent-Child Relations; Parents; Participant; Pathologist; Patients; Pediatric Hospitals; Persons; Phase; Population; Prevalence; Problem Solving; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Reading; Research; Risk; Rural; Sampling; Secure; Speech; Target Populations; Testing; Text Messaging; Training; Training Activity; Translating; Translations; Treatment Efficacy; Video Recording; Videoconferencing; Visit; Vulnerable Populations; base; craniofacial; efficacy testing; group intervention; high risk; improved; innovation; intervention delivery; literacy; novel; operation; oral cleft; palate repair; patient population; peer; pilot test; programs; recruit; remote delivery; remote intervention; rural area; skills; smartphone Application; social; telecoaching; treatment research

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.

项目摘要 与同龄人相比，有唇腭裂的儿童在语言和识字方面的缺陷风险更大。 然而，迄今为止，没有注意到可能抵消这些风险的干预措施。本研究将 第一个开发和测试共享阅读干预，以促进语言和新兴识字的年轻人 有唇沟的儿童。我们将根据这一人群的需求量身定制干预措施，确保该计划 可以与定期颅面预约协调进行，并使用创新的远程指导 促进传统上参与研究人数不足的家庭参与的战略 (e.g.,生活在农村地区的家庭）。具体来说，面对面的会议将与儿童的定期会议协调进行。 颅面护理在访问之间，护理人员将使用智能手机发送共享的视频记录， 干预者的阅读互动，以进行审查并提供鼓励和指导。本研究将 在3个主要中心的颅面诊所进行，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 洛杉矶。我们将翻译和审查所有材料的文化和语言适当的英语和 西班牙语家庭在研究的规划阶段（UG 3），我们将最终确定治疗方案， 研究方案（目标1）。我们将招募30名年龄在16至20个月大的唇腭裂儿童作为样本 和他们的照顾者进行简短的干预试验。这将使我们能够建立干预 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 试点还将证明干预是否涉及提议的行为目标（即，家长的阅读 行为）（目标3）。在实施阶段（UH 3），我们将进行一项随机对照试验， 对320名唇腭裂儿童及其家长进行干预。我们将招募腭修复后的参与者 (ages 16-20个月），随机分配一半接受干预，另一半接受仅提供信息的干预。 对照组干预将包括3个面对面会议和12个远程会议， 基线至36个月龄。RCT的目的包括（1）检验干预改善的假设 儿童的语言和识字结果在年龄36个月;（2a）测试的假设，干预 改善照顾者的共享阅读行为和（2b）儿童结果的改善是由以下因素介导的： 照顾者的共享阅读行为的变化;以及（3）基于以下因素检查结果的异质性： 人口统计学、临床和干预特征。这将是第一项研究，以检查干预， 解决唇裂儿童中观察到的语言和识字缺陷。除了改善护理外， 唇腭裂儿童，用于将干预范围扩大到农村和地理区域的战略 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。