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Hear Me Read 2021 Clinical Trial

Primary Purpose

Hearing Loss, Deafness, Hearing Disorders in Children

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Language Therapy
Digital Software Application
Sponsored by
Prasanth Pattisapu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring App, Speech and Language, Tablet, Digital, Literacy, Hearing Loss, Speech Therapy

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Speech Language Therapy

Speech Language Therapy + Digital Phase

Arm Description

Children who are deaf/hard of hearing will receive standard of care speech and language therapy with a speech language pathologist. Reading time is prescribed 20 min, 3x/week.

Children who are deaf/hard of hearing will receive standard of care speech and language therapy with a speech language pathologist with the addition of the digital app named, Hear Me Read, that will be used to achieve reading, speech and language goals through interactive digital storybook reading. Reading time is prescribed 20 min, 3x/week.

Outcomes

Primary Outcome Measures

Receptive One Word Picture Vocabulary Test
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: Sentence Comprehension
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: Word Structure
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: Expressive Vocabulary
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.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Following Directions
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: Recalling Sentences
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: Basic Concepts
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 and subtests: Word Classes
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: Core Language Score
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 Indices: Receptive Language Index
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 Indices: Expressive Language Index
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.

Secondary Outcome Measures

Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness
The Phonological Awareness (PA) subtest is used to evaluate the child's knowledge of the sound structure of language and ability to manipulate sound through compound word and syllable blending, sentence and syllable segmentation, and rhyme awareness and production. 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: Preliteracy Rating Scale
The Preliteracy Rating Scale (PRS) subtest is used to identify preliteracy skills that may influence development of reading and writing skills. The examiner provides or elicits information from a respondent about the child's early reading and writing skills. Raw scores (min = 0; max = 105) 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 Index: Early Literacy Index
Early Literacy Index (ELI) is a measure of performance on two subtests designed to assess early literacy skills. 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.

Full Information

First Posted
January 14, 2022
Last Updated
March 28, 2023
Sponsor
Prasanth Pattisapu
Collaborators
Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05245799
Brief Title
Hear Me Read 2021 Clinical Trial
Official Title
"Effectiveness of Adding a Novel Digital Storybook Intervention Platform in Therapy to Improve Speech, Language, and Literacy Outcomes in Children With Hearing Loss"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prasanth Pattisapu
Collaborators
Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Deafness, Hearing Disorders in Children, Hearing Impaired Children, Speech Therapy, Speech Disorders in Children, Literacy
Keywords
App, Speech and Language, Tablet, Digital, Literacy, Hearing Loss, Speech Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speech Language Therapy
Arm Type
Active Comparator
Arm Description
Children who are deaf/hard of hearing will receive standard of care speech and language therapy with a speech language pathologist. Reading time is prescribed 20 min, 3x/week.
Arm Title
Speech Language Therapy + Digital Phase
Arm Type
Experimental
Arm Description
Children who are deaf/hard of hearing will receive standard of care speech and language therapy with a speech language pathologist with the addition of the digital app named, Hear Me Read, that will be used to achieve reading, speech and language goals through interactive digital storybook reading. Reading time is prescribed 20 min, 3x/week.
Intervention Type
Behavioral
Intervention Name(s)
Speech Language Therapy
Intervention Description
Children who are deaf/hard of hearing will receive typical speech and language therapy with a speech pathologist. Reading time is prescribed 20 min, 3x/week.
Intervention Type
Behavioral
Intervention Name(s)
Digital Software Application
Other Intervention Name(s)
Hear Me Read
Intervention Description
The Hear Me Read app is an IOS-based software application that enables parents and speech-language pathologists to partner together to help deaf/hard of hearing children (D/HH) achieve reading, speech and language goals through interactive digital storybook reading.
Primary Outcome Measure Information:
Title
Receptive One Word Picture Vocabulary Test
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Sentence Comprehension
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Structure
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Expressive Vocabulary
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Following Directions
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Recalling Sentences
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Classes
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3: Core Language Score
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index
Description
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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
Description
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.
Time Frame
12- month intervention period
Secondary Outcome Measure Information:
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness
Description
The Phonological Awareness (PA) subtest is used to evaluate the child's knowledge of the sound structure of language and ability to manipulate sound through compound word and syllable blending, sentence and syllable segmentation, and rhyme awareness and production. 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.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale
Description
The Preliteracy Rating Scale (PRS) subtest is used to identify preliteracy skills that may influence development of reading and writing skills. The examiner provides or elicits information from a respondent about the child's early reading and writing skills. Raw scores (min = 0; max = 105) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Time Frame
12- month intervention period
Title
Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index
Description
Early Literacy Index (ELI) is a measure of performance on two subtests designed to assess early literacy skills. 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.
Time Frame
12- month intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasanth Pattisapu, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hear Me Read 2021 Clinical Trial

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