Clinical trial NCT04509739: Effect of Music Intervention on Infants' Brainstem Encoding of Speech
Official title: Effect of Music Intervention on Infants' Brainstem Encoding of Speech
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant Development
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-08-12
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: FFR-stimulus-f0 Correlation
timeFrame: The outcome measure was taken within 2 weeks following the completion of music intervention (i.e., the last intervention session)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Christina Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: