Speech Language Therapy + Digital Storybook for Childhood Hearing Loss

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Prashant Malhotra

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Prasanth Pattisapu, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 3 to nearly 6 with bilateral sensorineural or mixed hearing loss, including auditory neuropathy in both ears. It's not suitable for kids where English isn't the primary language or those who score more than 2 standard deviations from normal on a specific language test (CELF-P3).

Inclusion Criteria

I have hearing loss in both ears.

My child is between 3 and 5 years old.

I have hearing loss in both ears due to nerve damage.

Exclusion Criteria

Your test scores are more than 2 standard deviations away from normal on the CELF-P3 test.

English is not my first language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Period 1 (SLT)

Participants receive standard speech-language therapy as prescribed by their speech language pathologist. Reading time is prescribed at 20 minutes, 3 times a week, completed at home.

6 months

Intervention Period 2 (SLT+Digital)

Participants continue speech-language therapy with the addition of the Hear Me Read app. Reading time is prescribed at 20 minutes, 3 times a week, completed at home using the app.

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention periods

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Software Application
• Speech Language Therapy

Trial Overview The study compares traditional in-person speech-language therapy with and without the addition of a digital storybook platform called 'Hear Me Read' to see if it improves vocabulary, speech, language, and literacy in young children with hearing loss.

How Is the Trial Designed?

Group I: Speech Language Therapy + Digital Phase Experimental Treatment 2 Interventions

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 II: Speech Language Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Prashant Malhotra

Lead Sponsor

Trials

1

Recruited

50+

Prasanth Pattisapu

Lead Sponsor

Trials

1

Recruited

50+

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

Collaborator

Trials

1

Recruited

50+