Hearing Loss, Sensorineural Clinical Trial
Official title:
Training-Induced Language and Literacy Improvement in Children With Cochlear Implants
NCT number | NCT03582566 |
Other study ID # | 037312 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | June 2023 |
Verified date | July 2023 |
Source | Florida State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine the effectiveness of computer games to improve language and literacy outcomes for children who have hearing loss. Children will be assigned to one of four conditions: phonological awareness training, working memory training, phonological awareness + working memory training, or active control.
Status | Completed |
Enrollment | 87 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 7 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Evanston | Illinois |
United States | Florida State University | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida State University | Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Phonological Awareness Test scores | Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance. | Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline | |
Primary | Change inComprehensive Test of Phonological Awareness | Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance. | Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline | |
Primary | Change in Children's Test of Nonword Repetition | Change in a standardized test of verbal working memory | Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline | |
Secondary | Change in Oral Written Language Scales | 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. | Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline | |
Secondary | Change in Receptive/Expressive One Word Picture Vocabulary Test | Change in a standardized test of vocabulary knowledge. Scores are from 0-100 with higher scores indicating better performance. | Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline | |
Secondary | Change in Woodcock Johnson Reading Mastery Test | Change in a standardized test of early literacy skills. Scores are from 0-100 with higher scores indicating better performance. | Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline |
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