Hearing LossNCT05245799
Hear Me Read 2021 Clinical Trial
A study testing Speech Language Therapy and Digital Software Application in people with Hearing Loss and Deafness, run by Prasanth Pattisapu at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Hearing Loss, Deafness, Hearing Disorders in Children
- What is being tested?
- Speech Language Therapy and Digital Software Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- English not primary language
- Standard score CLS >2 SD from normal on CELF-P3
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: "Effectiveness of Adding a Novel Digital Storybook Intervention Platform in Therapy to Improve Speech, Language, and Literacy Outcomes in Children With Hearing Loss"
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.
Read the detailed 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.
- Conditions
- Hearing Loss, Deafness, Hearing Disorders in Children, Hearing Impaired Children, Speech Therapy, Speech Disorders in Children
- Being tested
- Speech Language Therapy, Digital Software Application
- Keywords
- App, Speech and Language, Tablet, Digital, Literacy, Hearing Loss, Speech Therapy
- Medical subject headings
- Hearing Loss, Deafness, Communication Disorders, Literacy, Alzheimer Disease, Speech, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Language TherapyBehavioural
Children who are deaf/hard of hearing will receive typical speech and language therapy with a speech pathologist. Reading time is prescribed 20 min, 3x/week.
Digital Software ApplicationBehavioural
Also called Hear Me Read
The Hear Me Read app is an IOS-based software application that enables parents and speech-language pathologists to partner together to help deaf/hard of hearing children (D/HH) achieve reading, speech and language goals through interactive digital storybook reading.
| Study group | Role | What they receive |
|---|---|---|
| Speech Language Therapy | Active comparator | 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. Receives: Behavioral: Speech Language Therapy |
| Speech Language Therapy + Digital Phase | Experimental | 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. Receives: Behavioral: Speech Language Therapy; Behavioral: Digital Software Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptive One Word Picture Vocabulary Test
The ROWPVT-4 is an individually administered assessment of how well persons can match a word that is heard to objects, actions, or concepts presented in full-color pictures. The examinee indicates the correct color picture that matches the word spoken by the examiner. Raw scores are reported as standard scores, percentile ranks, growth scale and age equivalents. Raw scores are from 0-100 with higher scores indicating better performance.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Sentence Comprehension
The Sentence Comprehension (SC) subtest is used to evaluate the child's ability to interpret spoken sentences of increasing length and complexity. The child identifies a picture that matches the sentence read aloud by the examiner. Raw scores (min = 0; max = 22) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher scaled scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Structure
The Word Structure (WS) subtest is used to evaluate the child's ability to (a) apply word structure rules to mark inflections, derivations, and comparison and (b) select and use appropriate pronouns to refer to people, objects, and possessive relationships. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Expressive Vocabulary
The Expressive Vocabulary (EV) subtest is used to evaluate the child's ability to label images of people, objects, attributes, and actions. The child names an object, person, or activity portrayed in a picture. Raw scores (min = 0; max = 42) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Following Directions
The Following Directions (FD) subtest is used to evaluate the child's ability to (a) interpret spoken directions of increasing length and complexity; (b) remember the names, characteristics, and order of mention of pictures; and (c) identify the targets from among several choices. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Recalling Sentences
The Recalling Sentences (RS) subtest is used to evaluate the child's ability to listen to spoken sentences of increasing length and complexity and repeat the sentences without changing word meanings, inflections, derivations or comparisons, or sentence structure. Raw scores (min = 0; max = 45) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts
The Basic Concepts (BC) subtest is used to evaluate the child's knowledge of concepts including direction/location/position, number/quantity, sequence, attributes, dimension/size, same/different, and inclusion/exclusion. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Classes
The Word Classes (WC) subtest is used to evaluate the child's ability to perceive relationships between words that are related by semantic class features. Raw scores (min = 0; max = 20) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3: Core Language Score
The Core Language Score (CLS) is a measure of general language ability that quantifies overall language performance and is used to make decisions about the presence or absence of a language disorder. It is derived by summing the scaled scores from the subtests that best discriminate typical language performance from disordered language performance deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index
The Receptive Language Index (RLI) is a measure of listening and auditory comprehension and is derived by summing the scaled scores from a combination of two or three receptive subtests. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
The Expressive Language Index (ELI) is a measure of performance on three tests that probe expressive aspects of language including oral language expression. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Measured: 12- month intervention period
Secondary outcomes (3)
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness
The Phonological Awareness (PA) subtest is used to evaluate the child's knowledge of the sound structure of language and ability to manipulate sound through compound word and syllable blending, sentence and syllable segmentation, and rhyme awareness and production. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale
The Preliteracy Rating Scale (PRS) subtest is used to identify preliteracy skills that may influence development of reading and writing skills. The examiner provides or elicits information from a respondent about the child's early reading and writing skills. Raw scores (min = 0; max = 105) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Measured: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index
Early Literacy Index (ELI) is a measure of performance on two subtests designed to assess early literacy skills. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Measured: 12- month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start25 Mar 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prasanth Pattisapu
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute
- Responsible party
- Sponsor-investigator, Prasanth Pattisapu, Nationwide Children's Hospital
- Investigators
- Prasanth Pattisapu, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245799
- Sponsor's protocol ID
- STUDY00001863
- Other IDs
- AWD00001881
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Adding a Novel Digital Storybook Intervention Platform in Therapy to Improve Speech, Language, and Literacy Outcomes in Children With Hearing Loss"
- ClinicalTrials.gov ID
- NCT05245799
- Acronym / sponsor ID
- STUDY00001863
- Conditions
- Hearing Loss, Deafness, Hearing Disorders in Children, Hearing Impaired Children, Speech Therapy, Speech Disorders in Children
- Keywords
- App, Speech and Language, Tablet, Digital, Literacy, Hearing Loss, Speech Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Prasanth PattisapuUniversity, hospital or other
- Collaborators
- Clinical and Translational Intramural Funding Program from the Abigail Wexner Research Institute
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speech Language Therapy | Active comparator | Behavioral: Speech Language TherapyChildren 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. |
| Speech Language Therapy + Digital Phase | Experimental | Behavioral: Speech Language Therapy, Behavioral: Digital Software ApplicationChildren 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- English not primary language
- Standard score CLS >2 SD from normal on CELF-P3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Language TherapyChildren who are deaf/hard of hearing will receive typical speech and language therapy with a speech pathologist. Reading time is prescribed 20 min, 3x/week. | Behavioural | Speech Language Therapy, Speech Language Therapy + Digital Phase |
| Digital Software ApplicationAlso: Hear Me ReadThe Hear Me Read app is an IOS-based software application that enables parents and speech-language pathologists to partner together to help deaf/hard of hearing children (D/HH) achieve reading, speech and language goals through interactive digital storybook reading. | Behavioural | Speech Language Therapy + Digital Phase |
Primary outcome
Receptive One Word Picture Vocabulary Test
Time frame: 12- month intervention period
The ROWPVT-4 is an individually administered assessment of how well persons can match a word that is heard to objects, actions, or concepts presented in full-color pictures. The examinee indicates the correct color picture that matches the word spoken by the examiner. Raw scores are reported as standard scores, percentile ranks, growth scale and age equivalents. Raw scores are from 0-100 with higher scores indicating better performance.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Sentence Comprehension
Time frame: 12- month intervention period
The Sentence Comprehension (SC) subtest is used to evaluate the child's ability to interpret spoken sentences of increasing length and complexity. The child identifies a picture that matches the sentence read aloud by the examiner. Raw scores (min = 0; max = 22) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher scaled scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Structure
Time frame: 12- month intervention period
The Word Structure (WS) subtest is used to evaluate the child's ability to (a) apply word structure rules to mark inflections, derivations, and comparison and (b) select and use appropriate pronouns to refer to people, objects, and possessive relationships. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Expressive Vocabulary
Time frame: 12- month intervention period
The Expressive Vocabulary (EV) subtest is used to evaluate the child's ability to label images of people, objects, attributes, and actions. The child names an object, person, or activity portrayed in a picture. Raw scores (min = 0; max = 42) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Following Directions
Time frame: 12- month intervention period
The Following Directions (FD) subtest is used to evaluate the child's ability to (a) interpret spoken directions of increasing length and complexity; (b) remember the names, characteristics, and order of mention of pictures; and (c) identify the targets from among several choices. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Recalling Sentences
Time frame: 12- month intervention period
The Recalling Sentences (RS) subtest is used to evaluate the child's ability to listen to spoken sentences of increasing length and complexity and repeat the sentences without changing word meanings, inflections, derivations or comparisons, or sentence structure. Raw scores (min = 0; max = 45) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts
Time frame: 12- month intervention period
The Basic Concepts (BC) subtest is used to evaluate the child's knowledge of concepts including direction/location/position, number/quantity, sequence, attributes, dimension/size, same/different, and inclusion/exclusion. Raw scores (min = 0; max = 24) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Word Classes
Time frame: 12- month intervention period
The Word Classes (WC) subtest is used to evaluate the child's ability to perceive relationships between words that are related by semantic class features. Raw scores (min = 0; max = 20) are reported as standard scores, percentile ranks, growth scale and age equivalents. Higher standard scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3: Core Language Score
Time frame: 12- month intervention period
The Core Language Score (CLS) is a measure of general language ability that quantifies overall language performance and is used to make decisions about the presence or absence of a language disorder. It is derived by summing the scaled scores from the subtests that best discriminate typical language performance from disordered language performance deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index
Time frame: 12- month intervention period
The Receptive Language Index (RLI) is a measure of listening and auditory comprehension and is derived by summing the scaled scores from a combination of two or three receptive subtests. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
Time frame: 12- month intervention period
The Expressive Language Index (ELI) is a measure of performance on three tests that probe expressive aspects of language including oral language expression. Scores are derived by summing the scaled scores from the subtests and deriving a standardized composite score (min = 45; max = 155). Higher composite scores represent better language outcomes.
3 secondary outcomes
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness
Time frame: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale
Time frame: 12- month intervention period
Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index
Time frame: 12- month intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasanth Pattisapu, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Language Therapy and Digital Software Application in people with Hearing Loss and Deafness, run by Prasanth Pattisapu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receptive One Word Picture Vocabulary Test (time frame: 12- month intervention period). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.