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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02998164
Other study ID # CIN001-Improving Outcomes
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date December 2025

Study information

Verified date January 2023
Source Children's Hospital Medical Center, Cincinnati
Contact Laura Smith, MPH
Phone 513-803-1901
Email laura.smith1@cchmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.


Recruitment information / eligibility

Status Recruiting
Enrollment 154
Est. completion date December 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria: - documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound); - identified with a language gap; - currently receiving speech-language therapy. Exclusion Criteria: - primary language other than English - significant motor impairments - nonverbal IQ <60 - children with severe communication disorders (i.e. autism spectrum disorders).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
augmentative and alternative communication technology

Usual Care
No change to the therapy care received

Locations

Country Name City State
United States Children's Hospital of Colorado Aurora Colorado
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Syntax Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks. Change between baseline and 24 weeks
Primary semantics Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks. Change between baseline and 24 weeks
Primary Discourse Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks. Assessing change between baseline and 24 weeks.
Secondary Language standard scores (receptive and expressive) Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment. Assessing change between baseline and 24 weeks.
Secondary Social functioning Social functioning as measured by parent-reported assessments or scales Assessing change between baseline and 24 weeks.
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