NCT02998164

Brief Summary

This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

9.2 years

First QC Date

November 10, 2016

Last Update Submit

December 17, 2025

Conditions

Hearing LossLanguage DevelopmentSocial Behavior

Outcome Measures

Primary Outcomes (3)

  • Syntax

    Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.

    Change between baseline and 24 weeks

  • semantics

    Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.

    Change between baseline and 24 weeks

  • Discourse

    Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.

    Assessing change between baseline and 24 weeks.

Secondary Outcomes (2)

  • Language standard scores (receptive and expressive)

    Assessing change between baseline and 24 weeks.

  • Social functioning

    Assessing change between baseline and 24 weeks.

Study Arms (2)

Technology-assisted language intervention

EXPERIMENTAL

This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy

Behavioral: augmentative and alternative communication technology

usual care

ACTIVE COMPARATOR

This group will be usual care children are already receiving.

Behavioral: Usual Care

Interventions

Usual CareBEHAVIORAL

No change to the therapy care received

usual care
augmentative and alternative communication technologyBEHAVIORAL
Technology-assisted language intervention

Eligibility Criteria

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

You may qualify if:

  • documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound);
  • identified with a language gap;
  • currently receiving speech-language therapy.

You may not qualify if:

  • primary language other than English
  • significant motor impairments
  • nonverbal IQ \<60
  • 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

Related Publications (3)

  • Betances E, Wiley S, Tabangin M, Sheldon R, Lane L, Mood D, Williams-Arya P, Schumacher J, Meinzen-Derr J. Preliteracy Skills in Young Children Who are Deaf/Hard of Hearing: Secondary Analysis of the Technology-assisted Language Intervention Randomized Trials. J Dev Behav Pediatr. 2025 Nov-Dec 01;46(6):e592-e598. doi: 10.1097/DBP.0000000000001394. Epub 2025 Jul 17.

    PMID: 40700591DERIVED

  • Mood D, Sheldon R, Tabangin M, Wiley S, Meinzen-Derr J. Technology assisted language intervention (TALI) for children who are deaf/hard of hearing: promising impact on pragmatic skills. Deafness Educ Int. 2022;24(4):334-355. doi: 10.1080/14643154.2022.2135731. Epub 2022 Nov 1.

    PMID: 37304207DERIVED

  • Meinzen-Derr J, Sheldon R, Altaye M, Lane L, Mays L, Wiley S. A Technology-Assisted Language Intervention for Children Who Are Deaf or Hard of Hearing: A Randomized Clinical Trial. Pediatrics. 2021 Feb;147(2):e2020025734. doi: 10.1542/peds.2020-025734. Epub 2021 Jan 15.

    PMID: 33452063DERIVED

MeSH Terms

Conditions

Hearing LossSocial Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jareen Meinzen-Derr, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

December 20, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

We currently do not have a IPD sharing plan. However, we will have one in place prior to the end of the study

Locations

US(2)