search
Back to results

Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning

Primary Purpose

Sensorineural Hearing Loss, Speech

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vocal-social reinforcement
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sensorineural Hearing Loss

Eligibility Criteria

7 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Parents are instructed to say nonsense words in response to infant babbles with a conserved phonological form as infant plays.

Parents are instructed to say nonsense words at random times with a conserved phonological form as infant plays.

Outcomes

Primary Outcome Measures

Change in Vocal Codes During Study Visit
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.

Secondary Outcome Measures

Change in Vocal Codes Between Visits
The same categories of speech maturity will be used at each study visit, allowing comparison of speech composition over time.
Perception
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).
MacArthur Communicative Development Inventory
This vocabulary inventory form will measure the breadth of the infant's known words and early sentence use.

Full Information

First Posted
November 4, 2022
Last Updated
April 21, 2023
Sponsor
University of Southern California
Collaborators
Cornell University, National Institute on Deafness and Other Communication Disorders (NIDCD)
search

1. Study Identification

Unique Protocol Identification Number
NCT05634356
Brief Title
Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning
Official Title
Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Cornell University, National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Infant vocal learning and development is embedded in a social feedback loop. Babbling vocalizations catalyze consistent responding by caregivers, and these predictable social reactions provide opportunities for infant learning. Naturalistic data and experimental manipulations have verified both the potency of babbling for eliciting social-vocal responses from caregivers, and the efficacy of social feedback for rapid advances in infant vocal learning. The impact of infant hearing loss, however, has never been studied with regard to the social feedback loop. Infants born with significant sensorineural hearing loss may be deprived not only of early auditory experience but of social experience as well. The reduction or elimination of social feedback to immature vocalizations, either by reduced or unpredictable parental responses or by infants' lessened ability to perceive those responses, is likely to have strong effects on learning and development of speech. Restoring hearing via cochlear implants improves auditory perception but does not remediate lost social learning opportunities or provide knowledge of how to learn from social partners. The goal of this project is to investigate how social interactions mediate the ability to incorporate phonological patterns of the language environment into vocal repertoires in infants with typical hearing versus infants with hearing loss (who either continue with hearing aids or experience gains in hearing via receipt of a cochlear implant). The investigators' method is to remotely observe naturally-occurring interactions between infants and a parent while recording their vocalizations; the investigators instruct the parent via headphones to provide vocal-social reinforcement to the infants when they produce a babbling utterance. Infant-parent dyads in a yoked control condition receive the same schedule of social reinforcement cues as a matched pair, which is random with respect to actual infant utterances in the control condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Speech

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We have a parallel design in which parent-infant dyads are assigned to either the intervention or to a random control group.
Masking
Participant
Masking Description
Parents are not informed of their group assignment.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Parents are instructed to say nonsense words in response to infant babbles with a conserved phonological form as infant plays.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parents are instructed to say nonsense words at random times with a conserved phonological form as infant plays.
Intervention Type
Behavioral
Intervention Name(s)
vocal-social reinforcement
Intervention Description
experimental manipulation of social reinforcement in response to vocalizations
Primary Outcome Measure Information:
Title
Change in Vocal Codes During Study Visit
Description
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.
Time Frame
Measured over the course of 30 minutes
Secondary Outcome Measure Information:
Title
Change in Vocal Codes Between Visits
Description
The same categories of speech maturity will be used at each study visit, allowing comparison of speech composition over time.
Time Frame
Measured at initial visit and up to three additional times between 30-180 days following the initial visit
Title
Perception
Description
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).
Time Frame
Measured at initial visit and up to three additional times between 30-180 days following the initial visit
Title
MacArthur Communicative Development Inventory
Description
This vocabulary inventory form will measure the breadth of the infant's known words and early sentence use.
Time Frame
assessed at 16 months and/or 6 months after initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah W Bottjer, Ph.D.
Phone
213-740-9183
Email
bottjer@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Nunez Rivera, B.S.
Email
mnunezri@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah W Bottjer, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah W Bottjer, Ph.D.
Phone
213-740-9183
Email
bottjer@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning

We'll reach out to this number within 24 hrs