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Clinical Trials/NCT03260062
NCT03260062
Completed
N/A

Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

University of Miami1 site in 1 country15 target enrollmentApril 11, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deafness, Bilateral
Sponsor
University of Miami
Enrollment
15
Locations
1
Primary Endpoint
Change in parental sensitivity
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. The study is being conducted to see if teaching parents positive parenting techniques and behavior strategies will improve the rate of language development in children with cochlear implants when compared to standard speech therapy (e.g., auditory-verbal therapy).

Registry
clinicaltrials.gov
Start Date
April 11, 2016
End Date
April 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ivette Cejas

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • children who are severely to profoundly deaf and a cochlear implant candidate,
  • children who are 12 to 48 months,
  • English or Spanish as primary language spoken at home,
  • families educating their children in spoken language,
  • children who pass the cognitive screening, scoring 75 or above on the screening measure

Exclusion Criteria

  • parents who do not consent to being videotaped,
  • children with moderate to severe developmental delays (as assessed using the Battelle Developmental Inventory (BDI-2) 2nd Edition for children ages 0 to 24 months or the Leiter International Performance Scale-Revised),
  • children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe brain abnormalities,
  • families who do not receive their auditory-verbal therapy from University of Miami (UM). Further, children who have already completed the BDI-2 within the past year as part of their Early Steps (Florida Early Intervention) program will not have it re-administered.

Outcomes

Primary Outcomes

Change in parental sensitivity

Time Frame: Baseline, Week 10

Parent sensitivity (warmth, positive regard, respect for child autonomy) will be coded from video-taped parent-child interactions during two play activities. Sensitivity will be coded on a 1 to 7 Likert scale, with higher scores indicating higher sensitivity.

Secondary Outcomes

  • Change in parental involvement and self-efficacy(Baseline, Week 10)
  • Change in Auditory Skills(Baseline, Week 10)
  • Change in use of higher-level versus lower-level language strategies(Baseline, Week 10)

Study Sites (1)

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