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Clinical Trials/NCT04857255
NCT04857255
Active, not recruiting
Not Applicable

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

Children's Hospital Medical Center, Cincinnati4 sites in 1 country114 target enrollmentOctober 15, 2020

Overview

Phase
Not Applicable
Intervention
Technology assisted language intervention
Conditions
Hearing Loss, Bilateral
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
114
Locations
4
Primary Endpoint
Clinical Evaluation of Language Fundamentals-5th edition
Status
Active, not recruiting
Last Updated
2 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
March 31, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Arms & Interventions

Technology Assisted Language Intervention (TALI)

Augmentative and alternative communication software incorporated into active speech-language therapy

Intervention: Technology assisted language intervention

Treatment as Usual

Speech language therapy child is typically receiving (no change to current care)

Intervention: Treatment as usual

Outcomes

Primary Outcomes

Clinical Evaluation of Language Fundamentals-5th edition

Time Frame: 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

Time Frame: 24 weeks

Measurement of syntax

Mean Turn Length

Time Frame: 24 weeks

Measurement of discourse

Number of different vocabulary words spoken

Time Frame: 24 weeks

measure of semantics

Secondary Outcomes

  • Expressive Vocabulary Test 2nd edition(24 weeks)
  • Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile(24 weeks)

Study Sites (4)

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