Back to resultsImproving Outcomes Using Technology for Children Who Are DHH
Primary Purpose
Hearing Loss, Language Development, Social Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
augmentative and alternative communication technology
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
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).
Sites / Locations
- Children's Hospital of Colorado
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Technology-assisted language intervention
usual care
Arm Description
This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy
This group will be usual care children are already receiving.
Outcomes
Primary Outcome Measures
Syntax
Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing 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.
Discourse
Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.
Secondary Outcome Measures
Language standard scores (receptive and expressive)
Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.
Social functioning
Social functioning as measured by parent-reported assessments or scales
Full Information
NCT ID
NCT02998164
First Posted
November 10, 2016
Last Updated
January 26, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Children's Hospital Colorado
1. Study Identification
Unique Protocol Identification Number
NCT02998164
Brief Title
Improving Outcomes Using Technology for Children Who Are DHH
Official Title
Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Children's Hospital Colorado
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Language Development, Social Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Technology-assisted language intervention
Arm Type
Experimental
Arm Description
This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
This group will be usual care children are already receiving.
Intervention Type
Behavioral
Intervention Name(s)
augmentative and alternative communication technology
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
No change to the therapy care received
Primary Outcome Measure Information:
Title
Syntax
Description
Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.
Time Frame
Change between baseline and 24 weeks
Title
semantics
Description
Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.
Time Frame
Change between baseline and 24 weeks
Title
Discourse
Description
Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.
Time Frame
Assessing change between baseline and 24 weeks.
Secondary Outcome Measure Information:
Title
Language standard scores (receptive and expressive)
Description
Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.
Time Frame
Assessing change between baseline and 24 weeks.
Title
Social functioning
Description
Social functioning as measured by parent-reported assessments or scales
Time Frame
Assessing change between baseline and 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Smith, MPH
Phone
513-803-1901
Email
laura.smith1@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jareen Meinzen-Derr, PhD
Phone
513-636-7789
Email
jareen.meinzen-derr@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jareen Meinzen-Derr, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Mood, PhD
Phone
720-777-2778
Email
Deborah.Mood@childrenscolorado.org
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jareen Meinzen-Derr, PhD
Phone
513-636-7789
Email
jareen.meinzen-derr@cchmc.org
First Name & Middle Initial & Last Name & Degree
Laura Smith, MPH
Phone
513-803-1901
Email
laura.smith1@cchmc.org
First Name & Middle Initial & Last Name & Degree
Susan Wiley, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
33452063
Citation
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.
Results Reference
derived
Learn more about this trial
Improving Outcomes Using Technology for Children Who Are DHH
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