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Completed

NCT Number: NCT01963468

Maximizing Language Development in Children With Hearing Loss

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

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Evanston, Illinois, 60202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early language intervention

Behavioral

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).

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Pre-Implantation Communication Treatment for Children With Hearing Loss

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2013
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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