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Maximizing Language Development in Children With Hearing Loss

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ClinicalTrials.gov Identifier: NCT01963468
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : March 29, 2018
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

Tracking Information
First Submitted Date  ICMJE October 11, 2013
First Posted Date  ICMJE October 16, 2013
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
MacArthur Communicative Development Inventories [ Time Frame: one month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01963468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
Preschool Language Scale [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 11, 2013)
Communication and Symbolic Behavior Scales [ Time Frame: 6 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Maximizing Language Development in Children With Hearing Loss
Official Title  ICMJE Pre-Implantation Communication Treatment for Children With Hearing Loss
Brief Summary The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Early language intervention
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2013)
30
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01963468
Other Study ID Numbers  ICMJE STU00081066
1R03DC012639 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Megan Roberts, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Megan Y Roberts, PhD, CCC-SLP Northwestern University
PRS Account Northwestern University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP