HealthyNCT04598438
Music to Enhance Auditory Encoding in Young Children
A study testing Music behavioral early intervention program and Arts and crafts early enhancement program in people with Healthy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The current pilot randomized control trial (RCT) examines whether active music participation enhances the encoding of speech in the neural auditory system which in turn leads to better language development in infants and toddlers. Read more about this study
- Who is it for?
- Ages Up to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Music behavioral early intervention program and Arts and crafts early enhancement program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Jun 2021to 16 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term infants, and their caregivers
- From families where Cantonese is the dominant language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Ching Man Lai, +852-39435469, evalai@cuhk.edu.hk
Patrick Chun Man Wong, Prof.
About this study
Official title: Music to Enhance Auditory Encoding in Young Children: A Pilot Study
The current pilot randomized control trial (RCT) examines whether active music participation enhances the encoding of speech in the neural auditory system which in turn leads to better language development in infants and toddlers. Healthy children will be randomized into either the music intervention treatment group or the arts and crafts active control group. Before and after treatment period, neural speech encoding and language and communication skills will be assessed. It is hypothesized that music intervention leads to enhanced neural speech encoding and language development compared to arts and crafts active control.
Read the 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.
- Conditions
- Healthy
- Being tested
- Music behavioral early intervention program, Arts and crafts early enhancement program
- Keywords
- Behavioral: Playgroup, Randomized Block Design, Therapy, Music, Parenting Education, Infant Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music behavioral early intervention programBehavioural
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.
Arts and crafts early enhancement programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music intervention treatment group | Experimental | Participants attending the music behavioral early intervention program Receives: Behavioral: Music behavioral early intervention program |
| Arts and crafts active control group | Active comparator | Participants attending the arts and crafts developmental enhancement program Receives: Behavioral: Arts and crafts early enhancement program |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFR auditory encoding measures
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.
Measured: Up to 1 year after intervention
Language developmental outcomes
The MacArthur-Bates Communicative Development Inventories (MCDI)-Cantonese version
Measured: Up to 1 year after intervention
Secondary outcomes (1)
Resting-state EEG signals
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.
Measured: Up to 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start4 Jun 2021
- Primary completion16 Oct 2022
- Study completion16 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick C. M. Wong, Chinese University of Hong Kong
- Investigators
- Patrick Chun Man Wong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598438
- Sponsor's protocol ID
- Music_playgroup1
- Status last verified
- Sep 2023
- First submitted
- 18 Oct 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27720749White-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.
PubMed 26172057Thompson 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.
PubMed 31430627Kraus 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.
PubMed 25186739Wilkinson 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.
PubMed 32656537Tardif, 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.
PubMed 24950492(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 at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music to Enhance Auditory Encoding in Young Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT04598438
- Acronym / sponsor ID
- Music_playgroup1
- Conditions
- Healthy
- Keywords
- Behavioral: Playgroup, Randomized Block Design, Therapy, Music, Parenting Education, Infant Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 16 Mar 2025 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current pilot randomized control trial (RCT) examines whether active music participation enhances the encoding of speech in the neural auditory system which in turn leads to better language development in infants and toddlers. Healthy children will be randomized into either the music intervention treatment group or the arts and crafts active control group. Before and after treatment period, neural speech encoding and language and communication skills will be assessed. It is hypothesized that music intervention leads to enhanced neural speech encoding and language development compared to arts and crafts active control.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention treatment group | Experimental | Behavioral: Music behavioral early intervention programParticipants attending the music behavioral early intervention program |
| Arts and crafts active control group | Active comparator | Behavioral: Arts and crafts early enhancement programParticipants attending the arts and crafts developmental enhancement program |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Full-term infants, and their caregivers
- From families where Cantonese is the dominant language
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music behavioral early intervention programThe 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. | Behavioural | Music intervention treatment group |
| Arts and crafts early enhancement programThe 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. | Behavioural | Arts and crafts active control group |
Primary outcome
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.
Language developmental outcomes
Time frame: Up to 1 year after intervention
The MacArthur-Bates Communicative Development Inventories (MCDI)-Cantonese version
1 secondary outcome
Resting-state EEG signals
Time frame: Up to 1 year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 27720749Wong 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.
- Background: PubMed 26172057White-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.
- Background: PubMed 31430627Thompson 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.
- Background: PubMed 25186739Kraus 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.
- Background: PubMed 32656537Wilkinson 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.
- BackgroundTardif, 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.
- Background: PubMed 24950492Roberts 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.
- Background(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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Chun Man Wong principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music behavioral early intervention program and Arts and crafts early enhancement program in people with Healthy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching Man Lai (+852-39435469, evalai@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FFR auditory encoding measures (time frame: Up to 1 year after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598438, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.