Maximizing Language Development in Children With Hearing Loss
Pre-Implantation Communication Treatment for Children With Hearing Loss
2 other identifiers
interventional
20
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 11, 2013
CompletedFirst Posted
Study publicly available on registry
October 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 29, 2018
March 1, 2018
3.2 years
October 11, 2013
March 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MacArthur Communicative Development Inventories
one month
Secondary Outcomes (1)
Preschool Language Scale
6 months
Other Outcomes (1)
Communication and Symbolic Behavior Scales
6 months
Study Arms (2)
Early language intervention
EXPERIMENTALChildren 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.
Monthly language check-ups
NO INTERVENTIONChildren will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely.
Interventions
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).
Eligibility Criteria
You may qualify if:
- to 18 months of age
- bilateral, moderate to profound congenital hearing loss
You may not qualify if:
- auditory neuropathy
- no known additional disabilities (e.g., cerebral palsy, Down syndrome)
- both parents have a severe to profound hearing loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Evanston, Illinois, 60202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Y Roberts, PhD, CCC-SLP
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 11, 2013
First Posted
October 16, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 29, 2018
Record last verified: 2018-03