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Clinical Trials/NCT05245799
NCT05245799
Enrolling By Invitation
Not Applicable

"Effectiveness of Adding a Novel Digital Storybook Intervention Platform in Therapy to Improve Speech, Language, and Literacy Outcomes in Children With Hearing Loss"

Prasanth Pattisapu1 site in 1 country50 target enrollmentMarch 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Prasanth Pattisapu
Enrollment
50
Locations
1
Primary Endpoint
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2022
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Prasanth Pattisapu
Responsible Party
Sponsor Investigator
Principal Investigator

Prasanth Pattisapu

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • English not primary language
  • Standard score CLS \>2 SD from normal on CELF-P3

Outcomes

Primary Outcomes

Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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