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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
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
erin ingvalson, Florida State University

Study Description
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Brief 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.

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

Detailed 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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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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.
 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.
 Behavioral: Working Memory
Cogmed training
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
Spashmath


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Florida State University
Northwestern University
Investigators
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Principal Investigator: Erin Ingvalson, PhD Florida State University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases