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 : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
|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.|
|Official Title:||Training-Induced Language and Literacy Improvement in Children With Cochlear Implants|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
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.
Behavioral: Phonological Awareness
Experimental: Working Memory
Children will play games designed to help them hold and manipulate objects in memory. These games are implemented in Cogmed.
Behavioral: Working Memory
Experimental: Phonological Awareness + Working Memory
Children will practice both their sound skills (Earobics) and their memory skills (Cogmed).
Behavioral: Phonological Awareness + Working Memory
Earobics + Cogmed training
Active Comparator: Active Control
Children will play games to practice their addition and subtraction skills (Splashmath).
Behavioral: Active Control
- 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
- 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
- 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
- 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
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 firstname.lastname@example.org|
|Principal Investigator: Erin Ingvalson, PhD|
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|Contact: Laura Sudec, MSW 847-491-3183 email@example.com|
|Principal Investigator: Megan Roberts, PhD|
|Principal Investigator:||Erin Ingvalson, PhD||Florida State University|