Maximizing Language Development in Children With Hearing Loss

NCT ID: NCT01963468

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early language intervention

Intervention Type 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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Megan Roberts

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Megan Y Roberts, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Evanston, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1R03DC012639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00081066

Identifier Type: -

Identifier Source: org_study_id

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