Trial Outcomes & Findings for Effect of Music Intervention on Infants' Brainstem Encoding of Speech (NCT NCT04509739)
NCT ID: NCT04509739
Last Updated: 2022-05-17
Results Overview
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.
TERMINATED
NA
17 participants
The outcome measure was taken within 2 weeks following the completion of music intervention (i.e., the last intervention session)
2022-05-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant became too fussy during the recording to generate usable data (17 enrolled, but only 16 included in baseline data). Additionally, the primary measure was only analyzed for the 15 individuals who completed the intervention (one infant didn't complete all intervention sessions)
Baseline characteristics by cohort
| Measure |
Music Intervention
n=16 Participants
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.
|
|---|---|
|
Age, Continuous
|
28.05 weeks
STANDARD_DEVIATION 1.06 • n=16 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=16 Participants
|
|
FFR-stimulus-f0 Correlation
|
0.034 FFR-stimulus-f0 correlation coefficient
STANDARD_DEVIATION 0.306 • n=15 Participants • One participant became too fussy during the recording to generate usable data (17 enrolled, but only 16 included in baseline data). Additionally, the primary measure was only analyzed for the 15 individuals who completed the intervention (one infant didn't complete all intervention sessions)
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Intervention
n=15 Participants
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.
|
|---|---|
|
FFR-stimulus-f0 Correlation
|
0.048 FFR-stimulus-f0 correlation coefficient
Standard Deviation 0.331
|
Adverse Events
Music Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place