Training Language and Literacy for Children Who Use CIs

July 12, 2023 updated by: erin ingvalson, Florida State University

Training-Induced Language and Literacy Improvement in Children With Cochlear Implants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
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.
Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
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
Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
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.
Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
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.
Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

Northwestern University

Investigators

  • Principal Investigator: Erin Ingvalson, PhD, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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