NCT03582566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

6.9 years

First QC Date

June 18, 2018

Last Update Submit

July 12, 2023

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • Change in Children's Test of Nonword Repetition

    Change in a standardized test of verbal working memory

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

Secondary Outcomes (3)

  • Change in Oral Written Language Scales

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

  • Change in Receptive/Expressive One Word Picture Vocabulary Test

    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

Study Arms (4)

Phonological Awareness

EXPERIMENTAL

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

Working Memory

EXPERIMENTAL

Children will play games designed to help them hold and manipulate objects in memory. These games are implemented in Cogmed.

Behavioral: Working Memory

Phonological Awareness + Working Memory

EXPERIMENTAL

Children will practice both their sound skills (Earobics) and their memory skills (Cogmed).

Behavioral: Phonological Awareness + Working Memory

Active Control

ACTIVE COMPARATOR

Children will play games to practice their addition and subtraction skills (Splashmath).

Behavioral: Active Control

Interventions

Phonological AwarenessBEHAVIORAL

Earobics training

Phonological Awareness
Working MemoryBEHAVIORAL

Cogmed training

Working Memory
Phonological Awareness + Working MemoryBEHAVIORAL

Earobics + Cogmed training

Phonological Awareness + Working Memory
Active ControlBEHAVIORAL

Spashmath

Active Control

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erin Ingvalson, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors are blind to treatment condition. Intervention providers are blind to assessment outcomes.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The efficacy of phonological awareness (Earobics) and working memory (Cogmed) training alone and in combination are compared to an active control (Splashmath).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 11, 2018

Study Start

July 1, 2016

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

US(2)