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.

Since the early 2000's, digital reading applications have enhanced the language and literacy skills of typically hearing young children; however, no digital storybook intervention currently exists to scaffold the early language and literacy skills of their peers who are deaf or hard of hearing. To address this gap, our research team developed a novel digital storybook intervention called Hear Me Read with the aim of enhancing the therapeutic, language, and literacy benefits of speech-language therapy. This prospective clinical trial (registered at clinicaltrials.gov, NCT#: 05245799) aims to determine the efficacy of adding Hear Me Read to in-person speech-language therapy for children aged three to five years who are deaf or hard of hearing. Fifty caregivers, their child, and their child's treating speech-language pathologist participate in the trial for 12 months. In the first six months, children attend standard-of-care speech-language therapy sessions. In the second six months, children continue to attend standard-of-care speech-language therapy sessions and use the Hear Me Read application, via a study supplied iPad. 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 vocabulary, speech, and language outcomes in children aged three to five years who are deaf or hard of hearing. The secondary outcome is that, compared to in-person speech-language therapy alone, in-person speech-language therapy with Hear Me Read will improve literacy outcomes in children aged three to five years who are deaf or hard of hearing. The goal of this intervention is to help children who are deaf or hard of hearing achieve their vocabulary, speech, language, and literacy goals through interactive digital storybook reading.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Malhotra developed a company, Digital Story Therapies, Inc, based on the technology inherent in the Hear Me Read application. A financial conflict of interest was identified. Immediately upon its identification, Dr. Malhotra created a Conflict Management Plan with his institution, halted role as Principal Investigator, and ceased all study related duties. These duties were transferred to Dr. Prasanth Pattisapu, the current Principal Investigator. Digital Story Therapies, Inc has no relationship or influence with the conduct of this clinical trial [See amended funding statement in cover letter].
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