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Completed

NCT Number: NCT04857255

Technology-assisted Language Intervention (TALI)

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

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Key information

Conditions

Hearing Loss, Bilateral Ear Diseases Hearing Disorders Hearing Loss Language Development Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Colorado, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Technology assisted language intervention

Behavioral

speech language therapy that has integrated technology delivered through specific software on an iPad

Treatment as Usual

Behavioral

No change will occur to the current ongoing speech-language therapy being delivered.

Primary outcomes

  1. Mean Length of Utterance in morphemes

    Time frame: 24 weeks

    Measurement of syntax

  2. Mean Turn Length

    Time frame: 24 weeks

    Measurement of discourse

  3. Number of different vocabulary words spoken

    Time frame: 24 weeks

    measure of semantics

  4. 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

Secondary outcomes

  1. Expressive Vocabulary Test 2nd edition

    Time frame: 24 weeks

    Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills

  2. Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile

    Time frame: 24 weeks

    Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: TALI

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 23, 2021
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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