Infant Development
Conditions
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.
Interventions
BEHAVIORALMusic 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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Music Intervention |
|---|---|
| Age, Continuous | 28.05 weeks STANDARD_DEVIATION 1.06 |
| FFR-stimulus-f0 Correlation | 0.034 FFR-stimulus-f0 correlation coefficient STANDARD_DEVIATION 0.306 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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.
Time frame: The outcome measure was taken within 2 weeks following the completion of music intervention (i.e., the last intervention session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Intervention | FFR-stimulus-f0 Correlation | 0.048 FFR-stimulus-f0 correlation coefficient | Standard Deviation 0.331 |