This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Maximizing Language Development in Children With Hearing Loss

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Megan Roberts, Northwestern University
ClinicalTrials.gov Identifier:
NCT01963468
First received: October 11, 2013
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.

Condition Intervention
Hearing Loss Behavioral: Early language intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre-Implantation Communication Treatment for Children With Hearing Loss

Resource links provided by NLM:


Further study details as provided by Megan Roberts, Northwestern University:

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

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

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

Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963468

Locations
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)
Investigators
Principal Investigator: Megan Y Roberts, PhD, CCC-SLP Northwestern University
  More Information

Responsible Party: Megan Roberts, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01963468     History of Changes
Other Study ID Numbers: STU00081066
1R03DC012639 ( US NIH Grant/Contract Award Number )
Study First Received: October 11, 2013
Last Updated: October 21, 2016

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

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

ClinicalTrials.gov processed this record on June 28, 2017