Training Language and Literacy for Children Who Use CIs
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ClinicalTrials.gov Identifier: NCT03582566 |
Recruitment Status :
Recruiting
First Posted : July 11, 2018
Last Update Posted : November 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hearing Loss, Sensorineural | Behavioral: Phonological Awareness Behavioral: Working Memory Behavioral: Phonological Awareness + Working Memory Behavioral: Active Control | Not Applicable |
Both phonological awareness and working memory are known to be important for children's language and literacy learning. Though there are computer games that claim to improve phonological awareness and working memory, it is unknown if these games will improve language and literacy skills for children who have hearing loss.
The investigators will first determine if the games are effective for improving language and phonological awareness in children with hearing loss relative to an active control condition. Secondly, the investigators will determine if gains in phonological awareness and working memory translate into gains in language and literacy skills relative to active control.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | The efficacy of phonological awareness (Earobics) and working memory (Cogmed) training alone and in combination are compared to an active control (Splashmath). |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Assessors are blind to treatment condition. Intervention providers are blind to assessment outcomes. |
Primary Purpose: | Treatment |
Official Title: | Training-Induced Language and Literacy Improvement in Children With Cochlear Implants |
Actual Study Start Date : | July 1, 2016 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Phonological Awareness
Children will play games to practice their rhyming, sound sequencing, and letter-sound knowledge. These games are all implemented in the Earobics program.
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Behavioral: Phonological Awareness
Earobics training |
Experimental: Working Memory
Children will play games designed to help them hold and manipulate objects in memory. These games are implemented in Cogmed.
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Behavioral: Working Memory
Cogmed training |
Experimental: Phonological Awareness + Working Memory
Children will practice both their sound skills (Earobics) and their memory skills (Cogmed).
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Behavioral: Phonological Awareness + Working Memory
Earobics + Cogmed training |
Active Comparator: Active Control
Children will play games to practice their addition and subtraction skills (Splashmath).
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Behavioral: Active Control
Spashmath |
- Change in Phonological Awareness Test scores [ Time Frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline ]Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance.
- Change inComprehensive Test of Phonological Awareness [ Time Frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline ]Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance.
- Change in Children's Test of Nonword Repetition [ Time Frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline ]Change in a standardized test of verbal working memory
- Change in Oral Written Language Scales [ Time Frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline ]Change in a standardized test of language and literacy skills. Measures performance on expressive and receptive language, and reading and writing abilities. Scores are age-adjusted.
- Change in Receptive/Expressive One Word Picture Vocabulary Test [ Time Frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline ]Change in a standardized test of vocabulary knowledge. Scores are from 0-100 with higher scores indicating better performance.
- Change in Woodcock Johnson Reading Mastery Test [ Time Frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline ]Change in a standardized test of early literacy skills. Scores are from 0-100 with higher scores indicating better performance.

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Ages Eligible for Study: | 5 Years to 7 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Prelingual hearing loss
- Use of amplification device (hearing aid and/or cochlear implant) for at least one year
- Able to visit the clinic 3x/week for 12 weeks
Exclusion Criteria:
- No developmental delays (Down's syndrome, Autism spectrum disorder)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582566
United States, Florida | |
Florida State University | Recruiting |
Tallahassee, Florida, United States, 32306 | |
Contact: Estrella Rodriguez, PhD 850-644-2238 ecrodriguez@fsu.edu | |
Principal Investigator: Erin Ingvalson, PhD | |
United States, Illinois | |
Northwestern University | Recruiting |
Evanston, Illinois, United States, 60208 | |
Contact: Laura Sudec, MSW 847-491-3183 laura.sudec@northwestern.edu | |
Principal Investigator: Megan Roberts, PhD |
Principal Investigator: | Erin Ingvalson, PhD | Florida State University |
Responsible Party: | erin ingvalson, Associate Professor, Florida State University |
ClinicalTrials.gov Identifier: | NCT03582566 |
Other Study ID Numbers: |
037312 |
First Posted: | July 11, 2018 Key Record Dates |
Last Update Posted: | November 26, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hearing Loss Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |