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

NCT05634356 | Recruiting

• 2 other identifiers: UP-18-006661R21DC019773
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss; Speech

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured over the course of 30 minutes

Secondary Outcomes (3)

• Change in Vocal Codes Between Visits

  Measured at initial visit and up to three additional times between 30-180 days following the initial visit

• Perception

  Measured at initial visit and up to three additional times between 30-180 days following the initial visit

• MacArthur Communicative Development Inventory

  assessed at 16 months and/or 6 months after initial visit

Study Arms (2)

Experimental

EXPERIMENTAL

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

Behavioral: vocal-social reinforcement

Control

NO INTERVENTION

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

Interventions

vocal-social reinforcement BEHAVIORAL

experimental manipulation of social reinforcement in response to vocalizations

Experimental

Eligibility Criteria

• Age: 7 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• Cornell University: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Speech

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah W Bottjer, Ph.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah W Bottjer, Ph.D.

CONTACT

213-740-9183; bottjer@usc.edu

Martin Nunez Rivera, B.S.

CONTACT

mnunezri@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Parents are not informed of their group assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biology & Psychology

Model Details: We have a parallel design in which parent-infant dyads are assigned to either the intervention or to a random control group.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 2, 2022
• Study Start: October 12, 2022
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)