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Speech Language Therapy + Digital Storybook for Childhood Hearing Loss

N/A

Waitlist Available

Led By Prashant S Malhotra, MD, FAAP

Research Sponsored by Prashant Malhotra

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Bilateral Sensorineural or mixed hearing loss at least (PTA≥30dB)

Male and female children ages 3.0-5.11 (5 years and 11 months) at time of initial assessment

Must not have

English not primary language

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12- month intervention period

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of adding a digital storybook intervention to in-person speech-language therapy for young children who are deaf or hard of hearing.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational interventions like speech therapy and digital applications rather than medical treatments, there are no typical side effects as one would expect from medication. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have hearing loss in both ears.

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My child is between 3 and 5 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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English is not my first language.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12- month intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12- month intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12- month intervention period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index

Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index

Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts

+8 more

Secondary study objectives

Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness

Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale

Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Speech Language Therapy + Digital PhaseExperimental Treatment2 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 TherapyActive Control1 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.

0 / 4Eligibility criteria met