Improving Outcomes Using Technology for Children Who Are DHH

Hearing Loss Clinical Trial

Official title:

Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998164
• Other study ID #: CIN001-Improving Outcomes
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Hearing Loss
• Language Development
• Social Behavior

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.