Music to Enhance Auditory Encoding in Young Children

September 7, 2023 updated by: Patrick C. M. Wong, Chinese University of Hong Kong

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.

Study Overview

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

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
        • Principal Investigator:
          • Patrick Chun Man Wong, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patrick Chun Man Wong, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Actual)

October 16, 2022

Study Completion (Estimated)

March 16, 2025

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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