Early Communication Intervention for Deaf/Hard of Hearing Toddlers: Long-Term Language and Literacy Outcomes
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)
研究概览
简要总结
The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support communication outcomes for deaf and hard-of-hearing (DHH) children. Previously, the investigators enrolled 96 DHH children between 12 and 18 months of age and their parents. Families were randomly assigned to receive either the PMI or a business-as-usual control group. The PMI was a 6-month intervention that included weekly, hour-long Zoom sessions. During the intervention sessions, parents were taught communication support strategies to support their child's language development throughout daily routines and play.
This current period of the trial follows the same children into early elementary school to determine whether the effects of the PMI are long-lasting. The main questions it aims to answer are:
- Does the PMI improve language, reading, and social communication outcomes in the early school years?
- Does parent involvement during early intervention support continued engagement in their child's education?
The investigators will compare parents and children who received the PMI to those in the business-as-usual control group to determine whether the intervention has lasting effects on these outcomes.
Participants will complete standardized assessments, parent-report surveys, and video-recorded naturalistic interactions. All assessments will be completed remotely.
详细描述
Hearing loss is one of the most prevalent congenital conditions. Recent advances in early detection and technology have contributed to significant improvements in long-term outcomes for deaf/hard-of-hearing (DHH) children. Despite this progress, language and literacy outcomes for school-age DHH children are inconsistent, and many DHH children do not "catch up" to their hearing peers. Closing this gap requires the implementation of effective early communication interventions. Yet, until recently, there was a significant paucity of research on early communication interventions for DHH children. Parent-mediated interventions (PMIs), which involve teaching parents strategies to enhance their child's language learning experiences, are a promising form of early intervention for DHH toddlers. During the previous project period (NCT03803943), 96 DHH children, between 12 and 18 months of age and their parents, were enrolled. Parent-child dyads were randomly assigned to receive either the PMI or business-as-usual control group. The investigators examined the effects of the intervention on (a) parent strategy use and (b) child communication outcomes during and after the 6-month intervention period. The follow-up period of the clinical trial is outlined here.
This trial will be the first large-scale evaluation of the long-term effects of an early communication intervention on school-age language and literacy outcomes for DHH children. The study enrolled 96 parent-child dyads, 88 of whom remain involved and consented to contact for the follow-up period. The investigators will complete follow-up assessments during early elementary school. The investigators plan to examine the long-term effects of the intervention on school-age outcomes and characterize the intermediary mechanisms of these effects. The investigators consider not only how early communication interventions affect subsequent child outcomes, but also how involving parents early in their child's development may lay the foundation for sustained parent engagement as children transition to school-based services. Taken together, the investigators plan to integrate child and parent outcomes to fully characterize how early language learning experiences shape long-term language and literacy outcomes. Understanding the pathways through which early interventions affect the developmental trajectory of DHH children will have widespread implications for research and clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and coders will be naive to the experimental condition
入排标准
- 年龄范围
- 5 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 12-18 months
- •diagnosed with bilateral hearing loss
- •no additional diagnoses (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.)
- •one parent with typical hearing
- •exposed to some degree of spoken language by their parents.
排除标准
- 未提供
研究组 & 干预措施
Parent-Mediated Intervention (PMI)
Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. In addition to these services, dyads in the PMI group participated in weekly intervention sessions via Zoom for 6 months.
Intervention sessions followed a Teach-Model-Coach-Review framework to support parents in using communication support strategies with their child. Parents were taught seven communication support strategies in a fixed sequence: (1) Setting the Stage, (2) Play and Engage, (3) Respond and Wait, (4) Notice and Say, (5) Show It, (6) Contrast It, and (7) Add On. These strategies focused on helping parents create opportunities for language learning during everyday routines and play, notice and respond to their child's communication, and model rich, salient language.
干预措施: Parent-Mediated Intervention (PMI) (Behavioral)
Business-As-Usual (BAU) Control
Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. Dyads in the BAU control group did not receive the PMI.
结局指标
主要结局
Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)
时间窗: 7 - 8 years old
The Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) is a standardized assessment of language development. The Core Language Standard Score (M = 100, SD = 15) reflects the child's global language ability, with higher scores indicating better language skills.
Peer-Peer Interaction, Pragmatic Observational Measure (POM)
时间窗: 7 - 8 years old
The Pragmatic Observational Measure (POM), a rating scale of pragmatic skills, will be scored during a naturalistic peer-peer interaction. The POM includes 27 items, capturing a range of pragmatic skills, rated on a 4-point scale (1 = rarely or never observed; 4 = almost always observed). The POM Total Raw Score (Min = 27, Max = 108) reflects the child's pragmatic skills, with higher scores indicating better pragmatic skills.
Woodcock Reading Mastery Tests, Third Edition (WRMT-III)
时间窗: 7 - 8 years old
The Woodcock Reading Mastery Tests, Third Edition (WRMT-III) is a standardized assessment of reading development. The Total Reading Cluster Standard Score (M = 100, SD = 15) reflects the child's global reading ability, with higher scores indicating better reading skills.
次要结局
- Parent-Child Interaction, Keys to Interactive Parenting Scale (KIPS)(5 - 6 years old)
- Parent Empowerment and Efficacy Measure (PEEM)(5 - 6 years old)
- Parental Involvement Survey in Their Child's Elementary Studies (PISCES)(5 - 6 years old)
- The Parent Advocacy Skills and Comfort Survey(5 - 6 years old)
- Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)(5 - 6 years old)
研究者
Megan Roberts
Principal Investigator
Northwestern University
