Effect of Music Intervention on Infants' Brainstem Encoding of Speech

Not Applicable

Terminated

• Conditions: Infant Development
• Interventions: Behavioral: Music intervention

• Registration Number: NCT04509739
• Lead Sponsor: University of Washington

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.

Detailed Description

Families with healthy infants with no family history of hearing, speech and communication disorders will be recruited at 7 months of age to participate in the longitudinal music intervention study that will last for about 4 months.

At recruitment, infants with 3 or more ear infections and infants who have already been/ have had participated in infant music classes will be excluded.

Infants will complete a pre-intervention brainstem measures at 7 months of age upon enrolling in the study: the frequency-following response measure (FFR). Participants will have to complete the measurement to proceed to the intervention phase. 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 on 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. Upon finishing the intervention, infants will repeat the FFR measurement at 11 months of age.

Study Timeline

• Study Start: 2019-10-16
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Results First Submitted: 2022-03-01
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Results First Posted: 2022-05-17
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Music intervention	Music intervention	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.

Primary Outcome Measures

Name	Time	Method
FFR-stimulus-f0 Correlation	The outcome measure was taken within 2 weeks following the completion of music intervention (i.e., the last intervention session)	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States