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CompletedNCT01963468Updated Mar 29, 2018

Maximizing Language Development in Children With Hearing Loss

An interventional study of Early language intervention in Hearing Loss, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
6 Months to 18 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Hearing Loss

Keywords

  • Hearing Loss
  • Cochlear Implant
  • Deaf
  • Hearing Impairment
  • Hard of Hearing
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 6 to 18 months of age
  • bilateral, moderate to profound congenital hearing loss

Exclusion criteria

Exclusion Criteria:

  • auditory neuropathy
  • no known additional disabilities (e.g., cerebral palsy, Down syndrome)
  • both parents have a severe to profound hearing loss
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralEarly 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).

06

What researchers measure

Primary outcomes

  1. MacArthur Communicative Development Inventories

    Time frame: one month

Secondary outcomes

  1. Preschool Language Scale

    Time frame: 6 months

Other outcomes

  1. Communication and Symbolic Behavior Scales

    Time frame: 6 months

07

Study locations

1 site
  • Northwestern University
    Evanston, Illinois 60202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01963468
Lead sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Megan Roberts (Assistant Professor, Northwestern University) — Principal investigator
First posted
Oct 16, 2013
Start date
Oct 2013
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 29, 2018

Study contacts

Megan Y Roberts, PhD, CCC-SLP
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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