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临床试验/NCT04598438
NCT04598438招募中不适用

Music to Enhance Auditory Encoding in Young Children: A Pilot Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年6月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Language developmental outcomes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
— 至 18 Months(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Music intervention treatment group

Experimental

Participants attending the music behavioral early intervention program

干预措施: Music behavioral early intervention program (Behavioral)

Arts and crafts active control group

Active Comparator

Participants attending the arts and crafts developmental enhancement program

干预措施: Arts and crafts early enhancement program (Behavioral)

结局指标

主要结局

Language developmental outcomes

时间窗: Up to 1 year after intervention

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

FFR auditory encoding measures

时间窗: 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.

次要结局

  • Resting-state EEG signals(Up to 1 year after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick C. M. Wong

Professor

Chinese University of Hong Kong

研究点 (1)

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