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临床试验/NCT07116200
NCT07116200进行中(未招募)不适用

Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication: A Randomized Controlled Trial

Ostfold University College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Phonological Awareness and Letter-Sound Correspondence Assessed in Kindergarten

研究概览

简要总结

The goal of this 2x2 factorial randomized controlled trial is to evaluate the effectiveness of two literacy interventions delivered at different time points, in kindergarten and in first grade, on the development of literacy skills in children with intellectual disabilities who require augmentative and alternative communication. The main questions it aims to answer are:

  • Does early intervention in kindergarten lead to greater improvements in phonological and phonemic awareness, vocabulary, and articulation compared to training as usual?
  • Does a follow-up intervention in first grade enhance decoding skills and sight word recognition beyond the gains achieved through the kindergarten intervention alone?
  • Does phonological awareness at the end of kindergarten mediate the relationship between early intervention and later outcomes in vocabulary, articulation, and decoding?
  • Do children who receive both interventions perform better than those who receive only one or none (training as usual), suggesting a cumulative or higher-dose effect?

Researchers will compare four arms formed through a 2x2 factorial design after randomization to see if whether timing, combination, and sequencing of interventions produce differential effects on literacy outcomes.

Participants will:

  • In kindergarten receive either an early literacy intervention or training as usual.
  • In first grade receive either a follow-up literacy intervention or training as usual, depending on group allocation.
  • Be assessed at key time points in both years, measuring phonological awareness, phonemic awareness, vocabulary, and articulation in kindergarten, and expanding to include decoding and sight word recognition in first grade.

详细描述

Literacy skills are fundamental in modern society. A significant portion of information is conveyed through written language. With the widespread use of the internet, written communication has become even more influential in our daily lives. The ability to read and write supports cognitive development, enhances social interactions, improves comprehension, and contributes to academic achievement. Conversely, a lack of literacy skills can limit access to general knowledge and deprive individuals of these important benefits.

One group that stands to gain significantly from literacy skills is individuals with intellectual disabilities who use augmentative and alternative communication. For these individuals, reading and writing can lead to enhanced self-esteem and increased opportunities for inclusion in school, the workplace, and the broader community.

Research has shown that individuals with intellectual disabilities who use augmentative and alternative communication can learn to read and write. However, it is crucial that literacy instruction is tailored to their specific needs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •children diagnosed with intellectual disability, confirmed by multidisciplinary assessments carried out by the Child rehabilitations service or currently undergoing such an evaluation
  • •ages 4-8 (the last year in kindergarten)
  • •lack of functional speech and must use augmentative and alternative communication as the primary form of communication
  • •have a (designated) special education kindergarten teacher

排除标准

  • •having a severe visual or hearing impairment
  • •children who can decode syllables or words
  • •children with severe physical disabilities prevent the children from being able to answer with their fingers, unless they can respond with eye pointing or signs

研究组 & 干预措施

Combined Intervention: Kindergarten and First Grade

Experimental

Participants in this arm will receive a structured literacy intervention in both kindergarten and first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, the intervention builds on these foundational skills and targets more advanced reading abilities, such as decoding and sight word recognition. Individualized intervention sessions are delivered by the participant's designated special needs educator or teacher at their respective kindergarten or school. This arm is designed to assess the cumulative effects of receiving both early literacy and reading interventions across kindergarten and first grade.

干预措施: Early Literacy Intervention in Kindergarten (Other)

Combined Intervention: Kindergarten and First Grade

Experimental

Participants in this arm will receive a structured literacy intervention in both kindergarten and first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, the intervention builds on these foundational skills and targets more advanced reading abilities, such as decoding and sight word recognition. Individualized intervention sessions are delivered by the participant's designated special needs educator or teacher at their respective kindergarten or school. This arm is designed to assess the cumulative effects of receiving both early literacy and reading interventions across kindergarten and first grade.

干预措施: Literacy Intervention in First Grade (Other)

Intervention in Kindergarten and Training as Usual in First Grade

Experimental

Participants in this arm will receive a structured literacy intervention in kindergarten and training as usual in first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, participants will receive training as usual, meaning they will follow the standard school curriculum without additional literacy intervention from the study. This arm is designed to evaluate the effects of early intervention alone, without follow-up support in first grade.

干预措施: Early Literacy Intervention in Kindergarten (Other)

Training as Usual in Kindergarten and Reading Intervention in First Grade

Experimental

Participants in this arm will receive training as usual during kindergarten and a structured reading intervention in first grade. During kindergarten, they will attend regular classroom instruction without receiving any early literacy intervention from the study. In first grade, they will participate in individualized reading intervention sessions focused on early literacy skills, decoding and sight word recognition, delivered by trained educators or specialists. This arm is designed to evaluate the effects of the first-grade reading intervention alone, without prior early literacy support.

干预措施: Literacy Intervention in First Grade (Other)

Training as Usual in Kindergarten and First Grade

No Intervention

Participants in this arm will receive training as usual during both kindergarten and first grade. They will attend standard classroom instruction without receiving any additional literacy intervention from the study. This arm serves as the control group and is designed to evaluate typical developmental progress in the absence of targeted intervention.

结局指标

主要结局

Phonological Awareness and Letter-Sound Correspondence Assessed in Kindergarten

时间窗: 5 weeks

All participants will be assessed five times in phonological awareness and letter-sound correspondence during their final year of kindergarten. These tests are part of the Reading for All materials.

Phonological Awareness, Letter-Sound Correspondence and Decoding Assessed in First Grade

时间窗: 5 weeks

All participants will be assessed five times in phonological awareness, letter-sound correspondence and decoding during first grade. These tests are part of the Reading for All materials.

次要结局

  • Vocabular assessment in kindergarten(2 weeks)
  • Articulation assessment in kindergarten(2 weeks)
  • Vocabular assessment in first grade(1 week)
  • Articulation assessment in first grade(1 week)

研究者

发起方
Ostfold University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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