Technology-assisted Language Intervention (TALI)

Language Development Clinical Trial

— TALI  

Official title:

Technology-assisted Language Intervention for Children Who Are Deaf/Hard-of-hearing (TALI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857255
• Other study ID #: R01DC018550
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Jareen Meinzen-Derr, PhD
• Phone: 513-636-7789
• Email: jareen.meinzen-derr[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: March 31, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• Age 3-10 years
• Documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound).
• Identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient <.85 or a differences in nonverbal IQ and language standard scores of 10 points. Language scores may either be receptive or expressive.
• Currently receiving speech-language therapy. Exclusion Criteria: Mild hearing loss and unilateral hearing loss
• primary language other than English
• significant motor impairments
• nonverbal IQ <80
• children with severe communication disorders (i.e. autism spectrum disorders).

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Language Development

Intervention

Behavioral:
• Technology assisted language intervention
speech language therapy that has integrated technology delivered through specific software on an iPad
• Treatment as usual
No change will occur to the current ongoing speech-language therapy being delivered.

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 (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Length of Utterance in morphemes	Measurement of syntax	24 weeks
Primary	Mean Turn Length	Measurement of discourse	24 weeks
Primary	Number of different vocabulary words spoken	measure of semantics	24 weeks
Primary	Clinical Evaluation of Language Fundamentals-5th edition	Provides receptive and expressive standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher language skills	24 weeks
Secondary	Expressive Vocabulary Test 2nd edition	Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills	24 weeks
Secondary	Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile	Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks	24 weeks