search
Back to results

Technology-assisted Language Intervention (TALI) (TALI)

Primary Purpose

Hearing Loss, Bilateral, Language Development

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology assisted language intervention
Treatment as usual
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Bilateral focused on measuring hearing loss, randomized clinical trial, intervention, language development

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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).

Sites / Locations

  • Children's Hospital of Colorado
  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Technology Assisted Language Intervention (TALI)

Treatment as Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Length of Utterance in morphemes
Measurement of syntax
Mean Turn Length
Measurement of discourse
Number of different vocabulary words spoken
measure of semantics
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

Secondary Outcome Measures

Expressive Vocabulary Test 2nd edition
Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills
Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile
Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks

Full Information

First Posted
April 19, 2021
Last Updated
February 13, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT04857255
Brief Title
Technology-assisted Language Intervention (TALI)
Acronym
TALI
Official Title
Technology-assisted Language Intervention for Children Who Are Deaf/Hard-of-hearing (TALI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 24, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Bilateral, Language Development
Keywords
hearing loss, randomized clinical trial, intervention, language development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology Assisted Language Intervention (TALI)
Arm Type
Active Comparator
Arm Description
Augmentative and alternative communication software incorporated into active speech-language therapy
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Speech language therapy child is typically receiving (no change to current care)
Intervention Type
Behavioral
Intervention Name(s)
Technology assisted language intervention
Intervention Description
speech language therapy that has integrated technology delivered through specific software on an iPad
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
No change will occur to the current ongoing speech-language therapy being delivered.
Primary Outcome Measure Information:
Title
Mean Length of Utterance in morphemes
Description
Measurement of syntax
Time Frame
24 weeks
Title
Mean Turn Length
Description
Measurement of discourse
Time Frame
24 weeks
Title
Number of different vocabulary words spoken
Description
measure of semantics
Time Frame
24 weeks
Title
Clinical Evaluation of Language Fundamentals-5th edition
Description
Provides receptive and expressive standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher language skills
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Expressive Vocabulary Test 2nd edition
Description
Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills
Time Frame
24 weeks
Title
Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile
Description
Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jareen Meinzen-Derr, PhD
Phone
513-636-7789
Email
jareen.meinzen-derr@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Lane, MPH
Phone
5138031901
Email
laura.smith1@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jareen Meinzen-Derr
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

Learn more about this trial

Technology-assisted Language Intervention (TALI)

We'll reach out to this number within 24 hrs