- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04598438
Music to Enhance Auditory Encoding in Young Children
Music to Enhance Auditory Encoding in Young Children: A Pilot Study
Study Overview
Status
Conditions
Detailed Description
Auditory encoding enables accurate representation of incoming speech signals, and can be measured by neural phase-locking to the frequencies of the speech stimulus via the frequency following response (FFR) (e.g., Wong et al., 2007). FFR measures are associated with a range of language processes including speech (Thompson et al., 2019) and literacy (White-Schwoch et al., 2015). Music intervention can lead to an enhanced FFR and auditory encoding in older children with poor language ability (e.g., Kraus et al., 2014). We therefore hypothesize that music intervention prescribed to young children (infants and toddlers) can also enhance FFR which will in turn enhance language and communication skills.
Participants: Cantonese-learning children between 8 to 12 months of age and their caregivers will participate in this research. All should report to be born healthy with gestational age of at least 37 weeks and birth weight of at least 2500g. We will enroll 48 children who will be randomized into the treatment or active control group (50% in each group) via blocked randomized (The Concise Encyclopedia of Statistics, 2008). Informed consent will be obtained from each family.
General Procedures: Within 2 weeks before and after treatment, children and families will undergo assessment (see outcome measures). Treatment will last for 10 weeks in a hybrid online and in-person delivery mode (see treatment procedures).
Outcome Measures: Infants will undergo EEG testing using an EEG system to elicit two types of responses, each lasting up to 10 minutes: 1) auditory encoding while they listen to auditory stimuli (e.g., Wong et al., 2007) and 2) resting-state EEG (e.g., Wilkinson et al., 2020). We will follow published procedures to derive neurophysiological metrics from the FFR signals such as pitch strength for speech encoding, and EEG spectral power analysis for amplitude of frequency bands at rest. The entire protocol will last under 30 min. Behavioral measures will include the MacArthur-Bates Communicative Development Inventories (MCDI)-Cantonese version (Tardif & Fletcher, 2008).
Treatment Procedures: Both treatment (music) and active control (arts and crafts) groups will consist of 10 weeks of training to take place online and in-person, led by a trained instructor. In addition, home practice will be assigned. Both will consist of a set of prescribed activities and materials and songs (for music treatment). For music, parents will be taught to use songs to implement activities to promote the child's auditory skills. For arts and crafts, a series of activities will promote visual perception (color, shape) and motor skills and encourage art making. A teach-model-coach-review approach (Roberts et al., 2014) will be implemented, with an important goal of teaching parents to implement the play sessions at home. Each family is required to complete a set of prescribed home practice activities and provide evidence of completion. These home activities will allow them to implement what they learn in the child's natural home environment and will encourage them to continue the activities they learn even after the completion of the treatment period.
Data Analysis: For each outcome measure, we will conduct a group x time ANOVA and expect a significant interaction. Posthoc analysis will reveal a larger, positive change in outcome measures for the treatment group relative to the control group.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ching Man Lai
- Phone Number: +852-39435469
- Email: evalai@cuhk.edu.hk
Study Contact Backup
- Name: Patrick Chun Man Wong
- Phone Number: +852-39437009
- Email: p.wong@cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- The Chinese University of Hong Kong
-
Contact:
- Ching Man Lai
- Phone Number: +852-39435469
- Email: evalai@cuhk.edu.hk
-
Principal Investigator:
- Patrick Chun Man Wong, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Full-term infants, and their caregivers
- From families where Cantonese is the dominant language
Exclusion Criteria:
- Infants reported to fail the hearing sensitivity screening
- Infants with mental or neuro-motor disabilities associated with atypical development (e.g. birth asphyxia; major injuries; hypoxic-ischemic injury; significant growth restriction, and other indications of neurological abnormalities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music intervention treatment group
Participants attending the music behavioral early intervention program
|
The program consists of carefully designed play-based enhancement strategies implemented in the form of hybrid online/in-person playgroups.
Following a teach-model-coach-review approach, parents will learn to implement various skills that are expected to enhance infant's language and communication skills through singing and engaging in musical play with their child at home.
|
|
Active Comparator: Arts and crafts active control group
Participants attending the arts and crafts developmental enhancement program
|
The program follows the same general structure with the music intervention program.
Parents will learn how to implement a series of arts and crafts activities at home, with an aim to enhance infant's visual-perceptual, motor, and sensory integration development.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FFR auditory encoding measures
Time Frame: Up to 1 year after intervention
|
Cortical and subcortical frequency following responses bands.
Neurophysiological metrics of FFR signals derived from published procedures of auditory-evoked EEG, such as pitch strength for speech encoding will be submitted to statistical analyses.
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Up to 1 year after intervention
|
|
Language developmental outcomes
Time Frame: Up to 1 year after intervention
|
The MacArthur-Bates Communicative Development Inventories (MCDI)-Cantonese version
|
Up to 1 year after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting-state EEG signals
Time Frame: Up to 1 year after intervention
|
EEG frequency bands measured at the resting-state.
Typical analyses for resting-state EEG, such as spectral power analysis for amplitude of frequency bands will be adopted.
|
Up to 1 year after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting practices and child-parent interaction
Time Frame: Up to 1 year after intervention
|
At each visit to the lab, caregivers and children may be asked to engage in several age-appropriate tasks, during which they may be videotaped.
Specifically, there will be semi-structured free play time (i.e.
Symbolic and Non-symbolic play), book reading and sharing, and cognitive tasks (e.g., solving puzzles) etc.
A parental questionnaire will be used to obtain paternal, maternal, and caregiver socio-demographic data, their health and family history, parenting style, and other relevant information about the caregivers.
|
Up to 1 year after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Chun Man Wong, Chinese University of Hong Kong
Publications and helpful links
General Publications
- Wong PCM, Vuong LC, Liu K. Personalized learning: From neurogenetics of behaviors to designing optimal language training. Neuropsychologia. 2017 Apr;98:192-200. doi: 10.1016/j.neuropsychologia.2016.10.002. Epub 2016 Oct 5.
- White-Schwoch T, Woodruff Carr K, Thompson EC, Anderson S, Nicol T, Bradlow AR, Zecker SG, Kraus N. Auditory Processing in Noise: A Preschool Biomarker for Literacy. PLoS Biol. 2015 Jul 14;13(7):e1002196. doi: 10.1371/journal.pbio.1002196. eCollection 2015 Jul.
- Thompson EC, Krizman J, White-Schwoch T, Nicol T, Estabrook R, Kraus N. Neurophysiological, linguistic, and cognitive predictors of children's ability to perceive speech in noise. Dev Cogn Neurosci. 2019 Oct;39:100672. doi: 10.1016/j.dcn.2019.100672. Epub 2019 Aug 6.
- Kraus N, Slater J, Thompson EC, Hornickel J, Strait DL, Nicol T, White-Schwoch T. Music enrichment programs improve the neural encoding of speech in at-risk children. J Neurosci. 2014 Sep 3;34(36):11913-8. doi: 10.1523/JNEUROSCI.1881-14.2014.
- Wilkinson CL, Gabard-Durnam LJ, Kapur K, Tager-Flusberg H, Levin AR, Nelson CA. Use of longitudinal EEG measures in estimating language development in infants with and without familial risk for autism spectrum disorder. Neurobiol Lang (Camb). 2020;1(1):33-53. doi: 10.1162/nol_a_00002. Epub 2020 Apr 6.
- Tardif, T., Fletcher, P., Zhang, Z. X., Liang, W. L., Zuo, Q. H., & Chen, P. (2008). User's guide and manual for the Chinese communicative development inventories (Putonghua and Cantonese). Beijing, China: Peking University Medical Press.
- Roberts MY, Kaiser AP, Wolfe CE, Bryant JD, Spidalieri AM. Effects of the teach-model-coach-review instructional approach on caregiver use of language support strategies and children's expressive language skills. J Speech Lang Hear Res. 2014 Oct;57(5):1851-69. doi: 10.1044/2014_JSLHR-L-13-0113.
- (2008) Randomized Block Design. In: The Concise Encyclopedia of Statistics. Springer, New York, NY. https://doi.org/10.1007/978-0-387-32833-1_344
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Music_playgroup1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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