Technology-assisted Language Intervention (TALI)

Not Applicable

Recruiting

• Conditions: Language Development; Hearing Loss, Bilateral
• Interventions: Behavioral: Treatment as usual; Behavioral: Technology assisted language intervention

• Registration Number: NCT04857255
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-24
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Treatment as usual	Speech language therapy child is typically receiving (no change to current care)
Technology Assisted Language Intervention (TALI)	Technology assisted language intervention	Augmentative and alternative communication software incorporated into active speech-language therapy

Primary Outcome Measures

Name	Time	Method
Clinical Evaluation of Language Fundamentals-5th edition	24 weeks	Provides receptive and expressive standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher language skills
Mean Length of Utterance in morphemes	24 weeks	Measurement of syntax
Mean Turn Length	24 weeks	Measurement of discourse
Number of different vocabulary words spoken	24 weeks	measure of semantics

Secondary Outcome Measures

Name	Time	Method
Expressive Vocabulary Test 2nd edition	24 weeks	Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills
Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile	24 weeks	Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks

Trial Locations

Locations (2)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States