Clinical trial NCT03582566: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2018-07-11
Enrollment: 87
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The efficacy of phonological awareness (Earobics) and working memory (Cogmed) training alone and in combination are compared to an active control (Splashmath).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Phonological Awareness Test scores
timeFrame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
measure: Change inComprehensive Test of Phonological Awareness
timeFrame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
measure: Change in Children's Test of Nonword Repetition
timeFrame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
Secondary outcomes:
measure: Change in Oral Written Language Scales
timeFrame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
measure: Change in Receptive/Expressive One Word Picture Vocabulary Test
timeFrame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
measure: Change in Woodcock Johnson Reading Mastery Test
timeFrame: Baseline, post-intervention (8 weeks post-baseline), 6 months post-baseline
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Florida State University
name: Erin Ingvalson, PhD
role: PRINCIPAL_INVESTIGATOR
References: