Maximizing Language Development in Children With Hearing Loss

Hearing Loss Clinical Trial

Official title:

Pre-Implantation Communication Treatment for Children With Hearing Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963468
• Other study ID #: STU00081066
• Secondary ID: 1R03DC012639
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: March 27, 2018
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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).

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Communication and Symbolic Behavior Scales		6 months
Primary	MacArthur Communicative Development Inventories		one month
Secondary	Preschool Language Scale		6 months