Hear Me Read 2021 Clinical Trial

NCT ID: NCT05245799

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Hearing Loss Deafness Hearing Disorders in Children Hearing Impaired Children Speech Therapy Speech Disorders in Children Literacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Speech Language Therapy

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

Speech Language Therapy

Intervention Type 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.

Digital Software Application

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Hear Me Read

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute

UNKNOWN

Sponsor Role collaborator

Prasanth Pattisapu

OTHER

Sponsor Role lead

Responsible Party

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Prasanth Pattisapu

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Prasanth Pattisapu, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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AWD00001881

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00001863

Identifier Type: -

Identifier Source: org_study_id

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