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Training Language and Literacy for Children Who Use CIs

Primary Purpose

Hearing Loss, Sensorineural

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Phonological Awareness

Working Memory

Phonological Awareness + Working Memory

Active Control

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Florida State University
Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Phonological Awareness

Working Memory

Phonological Awareness + Working Memory

Active Control

Arm Description

Children will play games to practice their rhyming, sound sequencing, and letter-sound knowledge. These games are all implemented in the Earobics program.

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

Change in Children's Test of Nonword Repetition

Change in a standardized test of verbal working memory

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03582566

First Posted

June 18, 2018

Last Updated

July 12, 2023

Sponsor

Florida State University

Collaborators

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT03582566

Brief Title

Training Language and Literacy for Children Who Use CIs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

June 2023 (Actual)

Study Completion Date

June 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Florida State University

Collaborators

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Sensorineural

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phonological Awareness

Arm Type

Experimental

Arm Description

Children will play games to practice their rhyming, sound sequencing, and letter-sound knowledge. These games are all implemented in the Earobics program.

Arm Title

Working Memory

Arm Type

Experimental

Arm Description

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

Arm Title

Phonological Awareness + Working Memory

Arm Type

Experimental

Arm Description

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

Arm Title

Active Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Phonological Awareness

Intervention Description

Earobics training

Intervention Type

Behavioral

Intervention Name(s)

Working Memory

Intervention Description

Cogmed training

Intervention Type

Behavioral

Intervention Name(s)

Phonological Awareness + Working Memory

Intervention Description

Earobics + Cogmed training

Intervention Type

Behavioral

Intervention Name(s)

Active Control

Intervention Description

Spashmath

Primary Outcome Measure Information:

Title

Change in Phonological Awareness Test scores

Description

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

Time Frame

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

Title

Change inComprehensive Test of Phonological Awareness

Description

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

Time Frame

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

Title

Change in Children's Test of Nonword Repetition

Description

Change in a standardized test of verbal working memory

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Oral Written Language Scales

Description

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.

Time Frame

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

Title

Change in Receptive/Expressive One Word Picture Vocabulary Test

Description

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

Time Frame

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

Title

Change in Woodcock Johnson Reading Mastery Test

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Ingvalson, PhD

Organizational Affiliation

Florida State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida State University

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32306

Country

United States

Facility Name

Northwestern University

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60208

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Training Language and Literacy for Children Who Use CIs

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