- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634356
Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning
The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from ~7-18 months. Infants have either typical hearing or sensorineural hearing loss. The main prediction of the study is that social reinforcement will engender improvements in vocal learning above and beyond gains in hearing in infants with hearing loss. As part of this study:
- The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words;
- Infants hear playback of the same words during a second phase.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah W Bottjer, Ph.D.
- Phone Number: 213-740-9183
- Email: bottjer@usc.edu
Study Contact Backup
- Name: Martin Nunez Rivera, B.S.
- Email: mnunezri@usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- Recruiting
- University of Southern California
-
Contact:
- Sarah W Bottjer, Ph.D.
- Phone Number: 213-740-9183
- Email: bottjer@usc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- infants ca. 7-16 months of age at study onset
- Infants less than 24 months of age (for follow-up visits only)
- At least one English-speaking or Spanish-speaking parent in the home who can participate in the study
- Subjects will include infants with typical hearing, hearing loss, or hearing loss remediated by a hearing aid or cochlear implant.
Exclusion Criteria:
- infants who are not exposed to English or Spanish in the home
- infants who do not have a parent who can participate in the study will be excluded (Caregivers who are not parents will not be eligible to participate in the study)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Parents are instructed to say nonsense words in response to infant babbles with a conserved phonological form as infant plays.
|
experimental manipulation of social reinforcement in response to vocalizations
|
No Intervention: Control
Parents are instructed to say nonsense words at random times with a conserved phonological form as infant plays.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vocal Codes During Study Visit
Time Frame: Measured over the course of 30 minutes
|
Infant vocalizations are assigned to categories of speech maturity, and frequency of each category will be assessed before, during, and after the cued responses from parents.
|
Measured over the course of 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vocal Codes Between Visits
Time Frame: Measured at initial visit and up to three additional times between 30-180 days following the initial visit
|
The same categories of speech maturity will be used at each study visit, allowing comparison of speech composition over time.
|
Measured at initial visit and up to three additional times between 30-180 days following the initial visit
|
Perception
Time Frame: Measured at initial visit and up to three additional times between 30-180 days following the initial visit
|
Infants will hear a recording of the same nonsense words spoken by their parent, and investigators will measure how long the infant looks in the direction of the word (how long the infant pays attention to each word).
|
Measured at initial visit and up to three additional times between 30-180 days following the initial visit
|
MacArthur Communicative Development Inventory
Time Frame: assessed at 16 months and/or 6 months after initial visit
|
This vocabulary inventory form will measure the breadth of the infant's known words and early sentence use.
|
assessed at 16 months and/or 6 months after initial visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-18-00666
- 1R21DC019773 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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