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Hearing Loss, SensorineuralNCT03582566

Training Language and Literacy for Children Who Use CIs

A study testing Phonological Awareness, Working Memory and Phonological Awareness + Working Memory in people with Hearing Loss, Sensorineural, run by Florida State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Hearing Loss, Sensorineural
What is being tested?
Phonological Awareness, Working Memory and Phonological Awareness + Working Memory
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
2 sitesUnited States
Study dates
1 Jul 2016to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • No developmental delays (Down's syndrome, Autism spectrum disorder)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern University

    Evanston, Illinois, 60208

  • Florida State University

    Tallahassee, Florida, 32306

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Phonological Awareness, Working Memory, Phonological Awareness + Working Memory, Active Control
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phonological AwarenessBehavioural

    Earobics training

  • Working MemoryBehavioural

    Cogmed training

  • Phonological Awareness + Working MemoryBehavioural

    Earobics + Cogmed training

  • Active ControlBehavioural

    Spashmath

Study groups in NCT03582566
Study groupRoleWhat they receive
Phonological AwarenessExperimentalChildren will play games to practice their rhyming, sound sequencing, and letter-sound knowledge. These games are all implemented in the Earobics program.
Receives: Behavioral: Phonological Awareness
Working MemoryExperimentalChildren will play games designed to help them hold and manipulate objects in memory. These games are implemented in Cogmed.
Receives: Behavioral: Working Memory
Phonological Awareness + Working MemoryExperimentalChildren will practice both their sound skills (Earobics) and their memory skills (Cogmed).
Receives: Behavioral: Phonological Awareness + Working Memory
Active ControlActive comparatorChildren will play games to practice their addition and subtraction skills (Splashmath).
Receives: Behavioral: Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Phonological Awareness Test scores

    Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance.

    Measured: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

  2. Change inComprehensive Test of Phonological Awareness

    Change in a standardized test of phonological awareness. Scores are from 0-100 with higher scores indicating better performance.

    Measured: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

  3. Change in Children's Test of Nonword Repetition

    Change in a standardized test of verbal working memory

    Measured: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

Secondary outcomes (3)

  1. Change in Oral Written Language Scales

    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.

    Measured: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

  2. Change in Receptive/Expressive One Word Picture Vocabulary Test

    Change in a standardized test of vocabulary knowledge. Scores are from 0-100 with higher scores indicating better performance.

    Measured: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

  3. Change in Woodcock Johnson Reading Mastery Test

    Change in a standardized test of early literacy skills. Scores are from 0-100 with higher scores indicating better performance.

    Measured: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start1 Jul 2016
  3. Primary completionJun 2023
  4. Study completionJun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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 blind
Who is masked
Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03582566
Sponsor's protocol ID
037312
Status last verified
Jul 2023
First submitted
18 Jun 2018
Last updated
13 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Phonological Awareness, Working Memory and Phonological Awareness + Working Memory in people with Hearing Loss, Sensorineural, run by Florida State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Phonological Awareness Test scores (time frame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03582566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

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