Effect of Music Intervention on Infants' Brainstem Encoding of Speech

NCT04509739 | Terminated Results

• 2 other identifiers: STUDY000108711R21NS114343-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Infants' frequency-following response (FFR) to a nonnative lexical tone, reflecting early sensory encoding of speech in the auditory system will be evaluated pre- and post- music intervention at 7 mo and 11 mo of age. The lab-controlled music intervention starts at 9 mo of age and consists of 12 sessions of social and multimodel musical activities with the aim to synchronize infants' movements with musical beats.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

• FFR-stimulus-f0 Correlation

  The FFR-stimulus-f0 correlation is an index of how well the auditory brainstem encode speech signals. It is calculated as the correlation coefficient between the fundamental frequency (f0) extracted from the stimulus and the f0 extracted from the FFR. The coefficient ranges between -1 to 1, with 1 indexing perfect positive correlation, -1 indexing perfect negative correlation and 0 indexing no correlation. Here, correlation in either direction is considered better than non-correlation.

  The outcome measure was taken within 2 weeks following the completion of music intervention (i.e., the last intervention session)

Study Arms (1)

Music intervention

EXPERIMENTAL

At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet. The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study.

Behavioral: Music intervention

Interventions

Music intervention BEHAVIORAL

At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet. The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study.

Music intervention

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy
• no family history of speech, hearing or language disorders
• no more than 3 ear infections
• no prior experience in infant music classes
• monolingual English speaking household

You may not qualify if:

• birth date more than 14 days before or after due date
• birth weight less than 6lbs0oz or more than 10lbs0oz
• family history of speech, hearing or language disorders
• history of 3 or more ear infections or hearing difficulties
• history of participating in infant music classes
• have significant exposure to languages other than English

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Limitations and Caveats

The trial ended prior to plan due to COVID-19. Resulting N was smaller than originally planned.

Results Point of Contact

• Title: Christina Zhao
• Organization: University of Washington

zhaotc@uw.edu

206-221-6415

Study Officials

• Christina Zhao, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor, Institute for Learning and Brain Sciences

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: October 16, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-05

Locations

US (1)