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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining standard speech-language therapy with a digital storybook app called Hear Me Read can improve vocabulary, speech, and literacy in young children who are deaf or hard of hearing. The trial will compare outcomes between two groups: one receiving only traditional therapy and another using both the therapy and the digital app. Children who might be a good fit have hearing loss in both ears and are between the ages of 3 to just under 6 years old. This trial may be of interest to those whose child primarily uses English and has a form of hearing loss. As an unphased study, the trial offers a unique opportunity to explore innovative ways to enhance communication skills.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital storybook intervention is safe for children with hearing loss?

Research has shown that speech-language therapy is generally safe and well-received. It is a common treatment for children who are deaf or hard of hearing and has been used safely for many years.

Early results suggest that the Hear Me Read digital storybook is a safe addition to this therapy. Designed to complement speech-language therapy, the app aims to improve reading and language skills. No reports of problems have emerged from its use.

Both the standard therapy and the digital app are non-invasive, meaning they don't involve any procedures inside the body. Because of this, they are unlikely to cause harm. So far, using both the therapy and the app together seems promising in helping children improve their language skills without added risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines traditional speech language therapy with an innovative digital component, aiming to enhance language skills in children with hearing loss. Unlike the standard care, which involves regular sessions with a speech language pathologist, this approach incorporates the "Hear Me Read" app, allowing children to engage with interactive digital storybooks. This digital phase not only supplements traditional therapy but also provides an engaging way for children to practice reading, speech, and language skills at home, potentially accelerating their progress and making learning more enjoyable.

What evidence suggests that this trial's treatments could be effective for childhood hearing loss?

Research has shown that digital reading apps can help young children with normal hearing improve their language and reading skills. In this trial, some participants will receive standard speech-language therapy, while others will receive therapy combined with the digital storybook platform, Hear Me Read. Early results suggest that using Hear Me Read alongside speech-language therapy might help children who are deaf or hard of hearing enhance their vocabulary, speech, language, and reading skills. These interactive digital storybooks aim to make learning more enjoyable, potentially leading to better outcomes than therapy alone. This method builds on the past successes of digital reading tools in improving communication skills. Early signs are encouraging, indicating that the digital component could be a valuable tool in supporting these children's development. ^{1 2 3 5 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05245799

Study Details | NCT05245799 | Hear Me Read 2021 ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11142545/

Study protocol for Hear Me Read (HMR): A prospective clinical ... The primary outcome of this trial is that, compared to in-person speech-language therapy alone, in-person speech-language therapy with Hear Me Read will improve ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0302734

Study protocol for Hear Me Read (HMR): A prospective clinical ... The goal of this intervention is to help children who are deaf or hard of hearing achieve their vocabulary, speech, language, and literacy goals ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38820413/

Study protocol for Hear Me Read (HMR): A prospective clinical ... Since the early 2000's, digital reading applications have enhanced the language and literacy skills of typically hearing young children; ...

5. researchgate.net researchgate.net/publication/381042273_Study_protocol_for_Hear_Me_Read_HMR_A_prospective_clinical_trial_assessing_a_digital_storybook_intervention_for_young_children_who_are_deaf_or_hard_of_hearing

(PDF) Study protocol for Hear Me Read (HMR) The goal of this intervention is to help children who are deaf or hard of hearing achieve their vocabulary, speech, language, and literacy goals.

6. pediatricsnationwide.org pediatricsnationwide.org/2024/02/27/hear-me-read-novel-technology-approach-to-reading-skills-for-children-with-impaired-hearing/

Hear Me Read: Novel Technology Approach to ... Hear Me Read is a first-of-its-kind digital storybook innovation targeted toward helping children with hearing impairment develop speech and ...