Hear Me Read 2021 Clinical Trial

NCT05245799 | Unknown

• 2 other identifiers: STUDY00001863AWD00001881
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• 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

• Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index

  12- month intervention period

Study Arms (2)

Speech Language Therapy

ACTIVE COMPARATOR

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

Speech Language Therapy + Digital Phase

EXPERIMENTAL

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; Behavioral: Digital Software Application

Interventions

Speech Language Therapy BEHAVIORAL

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.

Speech Language Therapy; Speech Language Therapy + Digital Phase

Digital Software Application BEHAVIORAL

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.

Also known as: Hear Me Read

Speech Language Therapy + Digital Phase

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prasanth Pattisapu: lead
• Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Hearing Loss; Deafness; Communication Disorders; Literacy; Alzheimer Disease; Speech; Language

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Verbal Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Prasanth Pattisapu, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 18, 2022
• Study Start: March 25, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)