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Clinical Trials/NCT03582566
NCT03582566CompletedNot Applicable

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

Florida State University4 sites in 1 country87 target enrollmentStarted: July 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
4
Primary Endpoint
Change in Children's Test of Nonword Repetition

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Assessors are blind to treatment condition. Intervention providers are blind to assessment outcomes.

Eligibility Criteria

Ages
5 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

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 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.

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.

Secondary Outcomes

  • Change in Receptive/Expressive One Word Picture Vocabulary Test(Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline)
  • Change in Oral Written Language Scales(Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline)
  • Change in Woodcock Johnson Reading Mastery Test(Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

erin ingvalson

Associate Professor

Florida State University

Study Sites (4)

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