Hear Me Read 2021 Clinical Trial

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hearing Loss; Deafness; Speech Therapy; Literacy; Hearing Impaired Children; Speech Disorders in Children; Hearing Disorders in Children
• Intervention / Treatment: Behavioral: Speech Language Therapy; Behavioral: Digital Software Application

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Speech Language Therapy; 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.	Behavioral: Speech Language Therapy; 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.
Experimental: Speech Language Therapy + Digital Phase; 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.	Behavioral: Speech Language Therapy; 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.; Behavioral: Digital Software Application; 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.; Other Names: Hear Me Read

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12- month intervention period
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.	12- month intervention period
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.	12- month intervention period

Collaborators and Investigators

• Sponsor: Prasanth Pattisapu
• Collaborators: Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute
• Investigators: Principal Investigator: Prasanth Pattisapu, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: App; Hearing Loss; Digital; Tablet; Speech Therapy; Literacy; Speech and Language
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Neurodevelopmental Disorders; Language Disorders; Disease; Hearing Loss; Deafness; Hearing Disorders; Speech Disorders; Communication Disorders
• Other Study ID Numbers: STUDY00001863; AWD00001881 (Other Grant/Funding Number: IFPAWRI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No