Hear Me Read 2021 Clinical Trial

Prasanth Pattisapu

Status: Invitation-only

Conditions: Literacy; Hearing Impaired Children; Speech Therapy; Hearing Disorders in Children; Hearing Loss; Speech Disorders in Children; Deafness

Treatments: Behavioral: Speech Language Therapy; Behavioral: Digital Software Application

Study type: Interventional

Funder types: Other

Identifiers

NCT05245799

STUDY00001863

AWD00001881 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Speech Language Therapy

Active Comparator group

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.

Treatment:

Behavioral: Speech Language Therapy

Speech Language Therapy + Digital Phase

Experimental group

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.

Treatment:

Behavioral: Digital Software Application

Behavioral: Speech Language Therapy