NCT02878824

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

August 15, 2016

Last Update Submit

June 1, 2017

Conditions

Keywords

NeurophysiologyAutonomicSensoryChildEthnicityEnvironment

Outcome Measures

Primary Outcomes (2)

  • Heart Rate Variability

    Heart rate variability (HRV) has been considered as a promising marker for autonomic activity, specifically of parasympathetic nervous system (PNS) activity (Task Force of the European Society of Cardiology and the North American Society for Pacing and Electrophysiology, 1996). Frequency domain analysis covers total power (0.0-0.5 Hz) in its raw and normalized units, low (LF; 0.04-0.15 Hz) and high (HF; 0.15-0.40 Hz) frequency components in its raw and normalized units. The normalized units of the LF will be used as representative of predominantly sympathetic modulation activity (SNS), while the normalized units of the HF will be used as representatives of parasympathetic modulation activity. Since HRV can measure both SNS and PNS simultaneously, this study will use HRV as one of the measurements. Nevertheless, it has been argued if the value of LF is a pure measure of SNS (Goldstein et al., 2011). Therefore, other than HRV, EDA will also be a supplementary measurement.

    Day 1

  • Electrodermal Activity

    Electrodermal activity (EDA) is a valid measure of autonomic nervous system activity frequently used to index behavioural processes (Boucsein, Fowles, Grimnes, Ben-Shakhar \& Roth, 2012). EDA is composed of a tonic and phasic drivers that reflect autonomic availability and response patterns respectively. Tonic EDA will be represented by the CDA.Tonic, which has been recommended to be the most accurate representation of the deconvoluted underlying skin conductance level within the specified block expressed in µS (Benedek \& Kaernbach, 2010). To represent the sympathetic activity in the form of phasic skin conductance response, the CDA.SCR will computed. The CDA.SCR is considered as the average phasic driver within the specified response window initially set, and represents the phasic EDA most accurately expressed in units of µS (Benedek \& Kaernbach, 2010).

    Day 1

Secondary Outcomes (3)

  • Sensory Behaviours: English and Chinese versions of the Sensory Profile

    Day 1

  • Temperament: English and Chinese versions of the Temperament in Middle Child Questionnaire and Early Adolescent Temperament Questionnaire

    Day 1

  • Resilience: English and Chinese versions of the Child and Youth Resilience Measure

    Day1

Other Outcomes (1)

  • Body-Mass Index

    Day 1

Study Arms (4)

HK-Children

This is a group of typically-developing children ages 7-12 years old who are of Chinese ethnicity, born and raised in Hong Kong (n=32).

Other: Ethnicity

FHK-Children

This is a group of typically-developing children ages 7-12 years old who are of Filipino ethnicity; either born, migrated and/or raised in Hong Kong (n=32).

Other: Ethnicity

FU-Children

This is a group of typically-developing children ages 7-12 years old who are of Filipino ethnicity, born and raised in an urban area in the Philippines (n=32).

Other: Environment

FR-Children

This is a group of typically-developing children ages 7-12 years old who are of Filipino ethnicity, born and raised in a rural area in the Philippines (n=32).

Other: Environment

Interventions

As mentioned by Goldberger and Veroff (1995) the concept of ethnicity is also associated with culture and is often used interchangeably with culture as well as with race. Ethnic differences are not necessarily inherited, but they are learned through constant exposure; however have strong genetic influences that explain consequent behavioural differences between different ethnic groups (Chudek \& Henrich, 2011). An individual's genetic makeup greatly affects their behaviours (Klahr \& Burt, 2014). In this study, we look at exposure to different ethnicity as exemplified by comparison between two groups of typically-developing children from different ethnicity (Chinese children in Hong Kong and Filipino Children in Hong Kong).

FHK-ChildrenHK-Children

The living environment has been implicated to have an effect on a person's psychological functioning (Rutter, Picker, Murray \& Eaves, 2001) and eventually how behaviour is manifested. The proposed disparity or effects between urban and rural dwelling is built on research that looks at the restorative and calming features of the natural environment, as well as the chaotic organization of the living spaces in urban settings.

FR-ChildrenFU-Children

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • male or female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Behavior

Interventions

EthnicityEnvironment

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Cynthia YY Lai, PhD

    The Hong Kong Polytechnic University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 25, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 30, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations