Clinical trial NCT02878824: Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children
Official title: Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children: A Neurophysiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Behavior
Keywords: Neurophysiology
Autonomic
Sensory
Child
Ethnicity
Environment
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 128
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For all participant groups, the recruited sample shall be males and females, aged 7-12 years old. Any participant with known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits will be excluded. All participants will also be screened for past pertinent medical history for any maladaptive behaviour in sensory processing in daily living. Those showing definite problem in sensory processing will be excluded from the study.

Brief summary: Difference in autonomic nervous system processes across cultural and ethnic groups was suggested and autonomic regulation differentiation may occur even at an early age. However, the role of ethnicity and environment on regulation of response towards sensory stimulation in children is not well understood yet. This research aims to compare the autonomic activity at resting condition and toward a block of auditory stimulation between typically developing children from different countries and living environments. There will be two phases in this study. In Phase I, two groups of participants will be recruited: (a) 32 typically-developing Chinese children living in Hong Kong, (HK group) and (b) 32 typically developing Filipino children living in Hong Kong (Fil-HK group). In phase II, two groups of participants will be recruited: (a) 32 typically-developing Filipino children who are living at Urban area (PH-U group), and (b) 32 typically developing Filipino children who are living at Philippines-Rural area (PH-R group). Participants will be composed of males and females ages 7-12 years old, and without known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited participants will watch a silent movie, and listen to a block of sound. Autonomic activity (heart rate variability and electrodermal activity) will be measured and recorded using Polar H2 heart rate monitor and eSense skin response. Recordings will be screened for ectopic beats of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and the eSense propriety software, respectively, and according to the standards of editing HRV and EDA artefacts. Autonomic activity (LF, HF and EDA) at resting condition, and hypothesis interaction between conditions (resting condition vs. auditory stimulation) and groups (HK group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested with repeated measures of MANOVA. All significant levels will be set at p≤ 0.05. This study will increase the understanding on the role of culture and environment in the regulation of behaviour in auditory processing. The findings of this research may further shed light on the evaluation and treatment planning for children across and within cultures.

Detailed description: Background: Difference in autonomic nervous system (ANS) processes across cultural and ethnic groups was suggested and autonomic regulation differentiation may occur even at an early age. However, the role of ethnicity and environment on regulation of response towards sensory stimulation in children is not well understood yet. This research aims to compare the autonomic activity at resting condition and toward a block of auditory stimulation between typically developing children from different countries and living environments and examine the role of environments and ethnicity on autonomic regulation.

Methods: Four groups of typically-developing participants will be recruited in this study: 1) Chinese children living in Hong Kong (n=32); Filipino children living in Hong Kong (32); Filipino children living in urban-Philippines (n=32); Filipino children living in urban-Philippines (n=32). Participants will be males (nm=16) and females (nf=16), ages 7-12 years old, and without known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited participants will watch a silent movie, and listen to a block of sound stimulus presentations. Autonomic activity (heart rate variability and electrodermal activity) will be measured and recorded using Polar H2 heart rate monitor and eSense GSR. Recordings will be screened for ectopic beats of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and Ledalab software, respectively, and according to the standards of editing and analysing HRV and EDA artefacts. Autonomic activity (LF, HF and EDA) at experimental condition groups (HK group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested with repeated measures of MANOVA. All significant levels will be set at a critical α=\> .05.

Discussion: This study will increase the understanding on the role of culture and environment in the regulation of behaviour in auditory processing. The findings of this research may further shed light on the evaluation and treatment planning for children across and within cultures.

Eligibility criteria: Inclusion Criteria:

* male or female
* 7-12 years old
* enrolled in primary school
* currently resides in the country/area in context
* for Hong Kong participants: Hong Kong-Chinese national
* for Philippine participants: born and living within the area in context

Exclusion Criteria:

* known history of developmental disabilities, medical history of cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits
* repeated a grade level
* multiracial parental background

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Day 1
measure: Electrodermal Activity
timeFrame: Day 1
Secondary outcomes:
measure: Sensory Behaviours: English and Chinese versions of the Sensory Profile
timeFrame: Day 1
measure: Temperament: English and Chinese versions of the Temperament in Middle Child Questionnaire and Early Adolescent Temperament Questionnaire
timeFrame: Day 1
measure: Resilience: English and Chinese versions of the Child and Youth Resilience Measure
timeFrame: Day1
Other outcomes:
measure: Body-Mass Index
timeFrame: Day 1
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Cynthia YY Lai, PhD
role: STUDY_DIRECTOR
References: