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Improving Outcomes Using Technology for Children Who Are DHH

NCT ID: NCT02998164

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss Language Development Social Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Technology-assisted language intervention

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

Group Type EXPERIMENTAL

augmentative and alternative communication technology

Intervention Type BEHAVIORAL

usual care

This group will be usual care children are already receiving.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

No change to the therapy care received

Interventions

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augmentative and alternative communication technology

Intervention Type BEHAVIORAL

Usual Care

No change to the therapy care received

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* primary language other than English
* significant motor impairments
* nonverbal IQ \<60
* children with severe communication disorders (i.e. autism spectrum disorders).
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Colorado

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jareen Meinzen-Derr, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Children's Hospital of Colorado

Aurora, Colorado, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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 Jul 17:10.1097/DBP.0000000000001394. doi: 10.1097/DBP.0000000000001394. Online ahead of print.

Reference Type DERIVED
PMID: 40700591 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37304207 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33452063 (View on PubMed)

Other Identifiers

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CIN001-Improving Outcomes

Identifier Type: -

Identifier Source: org_study_id