Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT05634356

Conditions

Sensorineural Hearing Loss

Speech

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Interventions

vocal-social reinforcement

Study Details

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

Study ID

NCT05634356

Start date

Oct 12, 2022

Status verified date

Jun, 2024

Completion date

Feb 1, 2025

Anticipated

Primary completion date

Nov 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental

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

no intervention: Control

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

Interventions

vocal-social reinforcement

experimental manipulation of social reinforcement in response to vocalizations

Primary outcome measure

  • Change in Vocal Codes During Study Visit [ Time Frame: Measured over the course of 30 minutes ]

Central Contacts and Locations

Central contacts

Sarah W Bottjer, Ph.D.

213-740-9183bottjer@usc.edu

Martin Nunez Rivera, B.S.

mnunezri@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Sarah W Bottjer, Ph.D.

213-740-9183bottjer@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2024-06-18.