"Effectiveness of Adding a Novel Digital Storybook Intervention Platform in Therapy to Improve Speech, Language, and Literacy Outcomes in Children With Hearing Loss"
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
研究概览
简要总结
The purpose of this study is to evaluate if the effects of in-person speech-language therapy with a novel digital storybook intervention platform (Hear Me Read) improves vocabulary, speech and language, and literacy outcomes in young children who are deaf or hard of hearing compared with in-person therapy alone.
详细描述
For this study, 50 children, who are deaf/hard of hearing, and their caregiver will be enrolled into 2 separate 6-month intervention periods, for a total of 12 months of participation. There are two intervention periods in this study, Intervention Period 1 (SLT) and Intervention Period 2 (SLT+Digital). Each one lasts about 6 months and every participant will participate in both intervention periods.
Intervention Period 1 is the speech-language therapy (SLT) only intervention. During this intervention, the child will go to speech therapy as normally prescribed by their speech language pathologist. There will be standardized reading time that is prescribed at 20 minutes, 3 times a week and will be completed at home by the child and caregiver.
Intervention Period 2 is the speech-language therapy with the Hear Me Read (SLT+Digital) intervention. During this intervention, the child will continue to go to speech therapy as they typically would, but will be asked to use the Hear Me Read app. There will be standardized reading time that is prescribed at 20 minutes, 3 times a week and will be completed at home by the child and caregiver using the Hear Me Read app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children ages 3.0-5.11 (5 years and 11 months) at time of initial assessment and:
- •Bilateral Sensorineural or mixed hearing loss at least (PTA≥30dB)
- •Auditory neuropathy in both ears
排除标准
- •English not primary language
- •Standard score CLS >2 SD from normal on CELF-P3
结局指标
主要结局
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
时间窗: 12- month intervention period
The Expressive Language Index (ELI) is a measure of performance on three tests that probe expressive aspects of language including oral language expression. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Receptive One Word Picture Vocabulary Test
时间窗: 12- month intervention period
The ROWPVT-4 is an individually administered assessment of how well persons can match a word that is heard to objects, actions, or concepts presented in full-color pictures. The examinee indicates the correct color picture that matches the word spoken by the examiner. Raw scores are reported as standard scores, percentile ranks, growth scale and age equivalents. Raw scores are from 0-100 with higher scores indicating better performance.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Following Directions
时间窗: 12- month intervention period
The Following Directions (FD) subtest is used to evaluate the child's ability to (a) interpret spoken directions of increasing length and complexity; (b) remember the names, characteristics, and order of mention of pictures; and (c) identify the targets from among several choices. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Structure
时间窗: 12- month intervention period
The Word Structure (WS) subtest is used to evaluate the child's ability to (a) apply word structure rules to mark inflections, derivations, and comparison and (b) select and use appropriate pronouns to refer to people, objects, and possessive relationships. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts
时间窗: 12- month intervention period
The Basic Concepts (BC) subtest is used to evaluate the child's knowledge of concepts including direction/location/position, number/quantity, sequence, attributes, dimension/size, same/different, and inclusion/exclusion. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3: Core Language Score
时间窗: 12- month intervention period
The Core Language Score (CLS) is a measure of general language ability that quantifies overall language performance and is used to make decisions about the presence or absence of a language disorder. It is derived by summing the scaled scores from the subtests that best discriminate typical language performance from disordered language performance deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Sentence Comprehension
时间窗: 12- month intervention period
The Sentence Comprehension (SC) subtest is used to evaluate the child's ability to interpret spoken sentences of increasing length and complexity. The child identifies a picture that matches the sentence read aloud by the examiner. Raw scores (min = 0; max = 22) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher scaled scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Recalling Sentences
时间窗: 12- month intervention period
The Recalling Sentences (RS) subtest is used to evaluate the child's ability to listen to spoken sentences of increasing length and complexity and repeat the sentences without changing word meanings, inflections, derivations or comparisons, or sentence structure. Raw scores (min = 0; max = 45) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Classes
时间窗: 12- month intervention period
The Word Classes (WC) subtest is used to evaluate the child's ability to perceive relationships between words that are related by semantic class features. Raw scores (min = 0; max = 20) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index
时间窗: 12- month intervention period
The Receptive Language Index (RLI) is a measure of listening and auditory comprehension and is derived by summing the scaled scores from a combination of two or three receptive subtests. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Expressive Vocabulary
时间窗: 12- month intervention period
The Expressive Vocabulary (EV) subtest is used to evaluate the child's ability to label images of people, objects, attributes, and actions. The child names an object, person, or activity portrayed in a picture. Raw scores (min = 0; max = 42) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
次要结局
- Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index(12- month intervention period)
- Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness(12- month intervention period)
- Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale(12- month intervention period)
研究者
Prasanth Pattisapu
Principal Investigator
Nationwide Children's Hospital