Clinical trial NCT05245799: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute
First posted: 2022-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Receptive One Word Picture Vocabulary Test
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Sentence Comprehension
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Structure
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Expressive Vocabulary
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Following Directions
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Recalling Sentences
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Classes
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3: Core Language Score
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
timeFrame: 12- month intervention period
Secondary outcomes:
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale
timeFrame: 12- month intervention period
measure: Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index
timeFrame: 12- month intervention period
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Prasanth Pattisapu, MD
role: PRINCIPAL_INVESTIGATOR
References: