Technology-assisted Language Intervention (TALI) (TALI)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hearing Loss, Bilateral; Language Development
• Intervention / Treatment: Behavioral: Technology assisted language intervention; Behavioral: Treatment as usual

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital of Colorado
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Technology Assisted Language Intervention (TALI); Augmentative and alternative communication software incorporated into active speech-language therapy	Behavioral: Technology assisted language intervention; speech language therapy that has integrated technology delivered through specific software on an iPad
Active Comparator: Treatment as Usual; Speech language therapy child is typically receiving (no change to current care)	Behavioral: Treatment as usual; No change will occur to the current ongoing speech-language therapy being delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Length of Utterance in morphemes	Measurement of syntax	24 weeks
Mean Turn Length	Measurement of discourse	24 weeks
Number of different vocabulary words spoken	measure of semantics	24 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jareen Meinzen-Derr, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intervention; randomized clinical trial; hearing loss; language development
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss; Hearing Loss, Bilateral; Therapeutics
• Other Study ID Numbers: R01DC018550 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No