Maximizing Language Development in Children With Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01963468
Recruitment Status : Active, not recruiting
First Posted : October 16, 2013
Last Update Posted : October 24, 2016
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Megan Roberts, Northwestern University

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

Condition or disease Intervention/treatment
Hearing Loss Behavioral: Early language intervention

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-Implantation Communication Treatment for Children With Hearing Loss
Study Start Date : October 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. MacArthur Communicative Development Inventories [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Preschool Language Scale [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Communication and Symbolic Behavior Scales [ Time Frame: 6 months ]

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01963468

United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60202
Sponsors and Collaborators
Northwestern University
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Megan Y Roberts, PhD, CCC-SLP Northwestern University

Responsible Party: Megan Roberts, Assistant Professor, Northwestern University Identifier: NCT01963468     History of Changes
Other Study ID Numbers: STU00081066
1R03DC012639 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016

Keywords provided by Megan Roberts, Northwestern University:
Hearing Loss
Cochlear Implant
Hearing Impairment
Hard of Hearing

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms