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Maximizing Language Development in Children With Hearing Loss

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early language intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Cochlear Implant, Deaf, Hearing Impairment, Hard of Hearing

Eligibility Criteria

6 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 6 to 18 months of age
  • bilateral, moderate to profound congenital hearing loss

Exclusion Criteria:

  • auditory neuropathy
  • no known additional disabilities (e.g., cerebral palsy, Down syndrome)
  • both parents have a severe to profound hearing loss

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early language intervention

Monthly language check-ups

Arm Description

Children will receive 6 months of weekly parent-implemented intervention sessions. Children will be assessed monthly via audio recordings and language checklists to monitor language development more closely.

Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely.

Outcomes

Primary Outcome Measures

MacArthur Communicative Development Inventories

Secondary Outcome Measures

Preschool Language Scale

Full Information

First Posted
October 11, 2013
Last Updated
March 27, 2018
Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT01963468
Brief Title
Maximizing Language Development in Children With Hearing Loss
Official Title
Pre-Implantation Communication Treatment for Children With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Loss, Cochlear Implant, Deaf, Hearing Impairment, Hard of Hearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early language intervention
Arm Type
Experimental
Arm Description
Children will receive 6 months of weekly parent-implemented intervention sessions. Children will be assessed monthly via audio recordings and language checklists to monitor language development more closely.
Arm Title
Monthly language check-ups
Arm Type
No Intervention
Arm Description
Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely.
Intervention Type
Behavioral
Intervention Name(s)
Early language intervention
Intervention Description
Parents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min).
Primary Outcome Measure Information:
Title
MacArthur Communicative Development Inventories
Time Frame
one month
Secondary Outcome Measure Information:
Title
Preschool Language Scale
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Communication and Symbolic Behavior Scales
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 6 to 18 months of age bilateral, moderate to profound congenital hearing loss Exclusion Criteria: auditory neuropathy no known additional disabilities (e.g., cerebral palsy, Down syndrome) both parents have a severe to profound hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Y Roberts, PhD, CCC-SLP
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States

12. IPD Sharing Statement

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Maximizing Language Development in Children With Hearing Loss

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