ChildrenNCT02878824
Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children
An observational study of Children and Behavior, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Ethnicity and Environment
- How many people
- 128 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2016to 30 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children: A Neurophysiological Study
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.
Read the 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.
- Being tested
- Ethnicity, Environment
- Keywords
- Neurophysiology, Autonomic, Sensory, Child, Ethnicity, Environment
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthnicityOther
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).
EnvironmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 1
Secondary outcomes (3)
Sensory Behaviours: English and Chinese versions of the Sensory Profile
To measure the child's behavioural patterns in response to sensory stimulus in his daily activities, we will use the original Sensory Profile (Dunn, 1999) and Chinese Sensory Profile (Cheung \& Siu, 2010). The original Sensory Profile which was developed and validated by Dunn (1999) is a 125 item questionnaire that is completed by the caregiver. The Chinese Sensory Profile was translated and validated by Cheung and Siu (2010) is a 100-item parent-report measure used among children and uses the same rating scale as with the original one. In this research, similar items from the original English version and Chinese versions of the Sensory Profile are identified and matched.
Measured: Day 1
Temperament: English and Chinese versions of the Temperament in Middle Child Questionnaire and Early Adolescent Temperament Questionnaire
Temperament will be measured using the Temperament in Middle Childhood Questionnaire (TMCQ; Simonds \& Rothbart, 2004; 2006) for 7-10 year old children; and the Early Adolescent Temperament Questionnaire (TMCQ; Ellis \& Rothbart, 2001) for children 11-12 years old. TMCQ is a 157-item parent questionnaire, while EATQ s 65-item form with a scale; both are parent-rated measures of reactive and regulative temperament traits among children using a 5-point Likert scale (a range of "Almost always untrue-1" to "Almost always true-5") for each item. The original version was developed using the English language. The Chinese translation of TMCQ (Lay et al., 2004) and EATQ (Lay \& Hsu, 2004) will be used Chinese-speaking participants.
Measured: Day 1
Resilience: English and Chinese versions of the Child and Youth Resilience Measure
The Child and Youth Resilience Measure [37] (CYRM) was established through a process of interviews with youth and adults in countries around the world was completed by the participants' parents. This research uses the 28-item (> 10 yrs. old) or 26 item (5-9 yrs. old) Person-Most-Knowledgeable questionnaire version, which was developed and validated by Ungar and Liebenberg [38]. While the CYRM is originally in English, a translated Chinese version was recommended and provided by the authors and was used among Chinese participants in this research. Parents rate each item with three possible response: "Yes," "Sometimes" or "No."
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GOMEZ Ivan Neil Benitez, The Hong Kong Polytechnic University
- Investigators
- Cynthia YY Lai, PhD, Study director, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878824
- Sponsor's protocol ID
- HSEARS20150316001-01
- Status last verified
- Jun 2017
- First submitted
- 15 Aug 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ethnicity and Environment on Regulation of Response Towards Sensory Stimulation in Children: A Neurophysiological Study
- ClinicalTrials.gov ID
- NCT02878824
- Acronym / sponsor ID
- HSEARS20150316001-01
- Keywords
- Neurophysiology, Autonomic, Sensory, Child, Ethnicity, Environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HK-Children | – | Other: EthnicityThis 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). |
| FHK-Children | – | Other: EthnicityThis 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). |
| FU-Children | – | Other: EnvironmentThis 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). |
| FR-Children | – | Other: EnvironmentThis 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). |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthnicityAs 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). | Other | FHK-Children, HK-Children |
| EnvironmentThe 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. | Other | FR-Children, FU-Children |
Primary outcome
Heart Rate Variability
Time frame: Day 1
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.
Electrodermal Activity
Time frame: Day 1
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).
3 secondary outcomes
Sensory Behaviours: English and Chinese versions of the Sensory Profile
Time frame: Day 1
Temperament: English and Chinese versions of the Temperament in Middle Child Questionnaire and Early Adolescent Temperament Questionnaire
Time frame: Day 1
Resilience: English and Chinese versions of the Child and Youth Resilience Measure
Time frame: Day1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia YY Lai, PhD study director
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Behavior, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.