NCT04598438

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2022

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2025

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

October 18, 2020

Last Update Submit

September 7, 2023

Conditions

Healthy

Keywords

Behavioral: PlaygroupRandomized Block DesignTherapy, MusicParenting EducationInfant Development

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 1 year after intervention

  • Language developmental outcomes

    The MacArthur-Bates Communicative Development Inventories (MCDI)-Cantonese version

    Up to 1 year after intervention

Secondary Outcomes (1)

  • Resting-state EEG signals

    Up to 1 year after intervention

Other Outcomes (1)

  • Parenting practices and child-parent interaction

    Up to 1 year after intervention

Study Arms (2)

Music intervention treatment group

EXPERIMENTAL

Participants attending the music behavioral early intervention program

Behavioral: Music behavioral early intervention program

Arts and crafts active control group

ACTIVE COMPARATOR

Participants attending the arts and crafts developmental enhancement program

Behavioral: Arts and crafts early enhancement program

Interventions

Music behavioral early intervention programBEHAVIORAL

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.

Music intervention treatment group
Arts and crafts early enhancement programBEHAVIORAL

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.

Arts and crafts active control group

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full-term infants, and their caregivers
  • From families where Cantonese is the dominant language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (8)

  • 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.

    PMID: 27720749BACKGROUND

  • 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.

    PMID: 26172057BACKGROUND

  • 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.

    PMID: 31430627BACKGROUND

  • 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.

    PMID: 25186739BACKGROUND

  • 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.

    PMID: 32656537BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 24950492BACKGROUND

  • (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

    BACKGROUND

Study Officials

  • Patrick Chun Man Wong

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching Man Lai

CONTACT

+852-39435469evalai@cuhk.edu.hk

Patrick Chun Man Wong

CONTACT

+852-39437009p.wong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 22, 2020

Study Start

June 4, 2021

Primary Completion

October 16, 2022

Study Completion

March 16, 2025

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

HK(1)