Maximizing Language Development in Children With Hearing Loss

March 27, 2018 updated by: Megan Roberts, Northwestern University

Pre-Implantation Communication Treatment for Children With Hearing Loss

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
    • Illinois
      • Evanston, Illinois, United States, 60202
        • Northwestern University

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

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early language intervention

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.
Behavioral: Early language intervention
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).
No Intervention: Monthly language check-ups
Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MacArthur Communicative Development Inventories
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
Preschool Language Scale
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Communication and Symbolic Behavior Scales
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Megan Y Roberts, PhD, CCC-SLP, Northwestern University

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, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00081066
  • 1R03DC012639 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Hearing Loss

Clinical Trials on Early language intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe