Improving Outcomes Using Technology for Children Who Are DHH

January 26, 2023 updated by: Children's Hospital Medical Center, Cincinnati

Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital of Colorado
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Technology-assisted language intervention
This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy
Behavioral: augmentative and alternative communication technology
Active Comparator: usual care
This group will be usual care children are already receiving.
Behavioral: Usual Care
No change to the therapy care received

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syntax
Time Frame: Change between baseline and 24 weeks
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
Time Frame: Change between baseline and 24 weeks
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
Time Frame: Assessing change between baseline and 24 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Language standard scores (receptive and expressive)
Time Frame: Assessing change between baseline and 24 weeks.
Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.
Assessing change between baseline and 24 weeks.
Social functioning
Time Frame: Assessing change between baseline and 24 weeks.
Social functioning as measured by parent-reported assessments or scales
Assessing change between baseline and 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Children's Hospital Colorado

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN001-Improving Outcomes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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