NCT04857255

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5.5 years

First QC Date

April 19, 2021

Last Update Submit

February 6, 2026

Conditions

Keywords

hearing lossrandomized clinical trialinterventionlanguage development

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Expressive Vocabulary Test 2nd edition

    24 weeks

  • Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile

    24 weeks

Study Arms (2)

Technology Assisted Language Intervention (TALI)

ACTIVE COMPARATOR

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

Behavioral: Technology assisted language intervention

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Interventions

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

Technology Assisted Language Intervention (TALI)

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

Treatment as Usual

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Hearing Loss, BilateralHearing Loss

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jareen Meinzen-Derr

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 23, 2021

Study Start

October 15, 2020

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations