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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2023
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Phonological Awareness
Earobics training
Working Memory
Cogmed training
Phonological Awareness + Working Memory
Earobics + Cogmed training
Active Control
Spashmath

Locations

Country Name City State
United States Northwestern University Evanston Illinois
United States Florida State University Tallahassee Florida

Sponsors (2)

Lead Sponsor Collaborator
Florida State University Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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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