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Completed

NCT Number: NCT03582566

Training Language and Literacy for Children Who Use CIs

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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Phonological Awareness

Behavioral

Earobics training

Working Memory

Behavioral

Cogmed training

Phonological Awareness + Working Memory

Behavioral

Earobics + Cogmed training

Active Control

Behavioral

Spashmath

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Northwestern University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2018
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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