Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836286
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2020-11-16
Brief Title:
Determining the Impact of Emotive Intelligent Spaces
Sponsor:
University of Idaho
Organization:
University of Idaho
Study Overview
Official Title:
Determining the Impact of Emotive Intelligent Space on Childrens Self-Regulation and Cognitive Performance
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EIS
Brief Summary:
Many children age 3-6 living in the Mountain West MW region face unique challenges that can affect their health and welfare such as lower socioeconomic status and limited access to healthcare and education The proposed project aims to address those health and education gaps by improving childrens self-regulation ie the ability to control emotional and behavioral impulses a critical cognitive skill that underpins future mental health and academic achievement The project will test the effectiveness of an innovative intervention mechanism the Emotive Intelligent Space EIS
The EIS consists of two adjacent 3 x 5 sq ft wooden wall panels with colored LED lights creating a 90-degree semi-private space The adaptable colored lightings are controlled by a machine learning algorithm that is developed based on a co-investigators prior study The EIS harnesses the power of artificial intelligence to detect childrens emotions from physiological data in real-time and to translate physiological signals into environmental changes ie adaptable colored lighting that adequately respond to childrens emotions resulting in improved self-regulation physiological stress responses and cognitive performance
The objective of this proposal is to determine the effect of EIS on childrens age 3-6 self-regulation physiological and cognitive outcomes by employing a repeated ABAB experimental design A no intervention B EIS intervention The hypothesis is that EIS will positively impact childrens self-regulation physiological stress response and cognitive performance Based on a priori power analysis 40 preschool and kindergarten children will be recruited from early childhood programs in the rural areas near Moscow ID During the experiment children will be assessed under a combination of A and B conditions A digital wristband will capture childrens real-time physiological responses ie Galvanic skin response body temperature and blood volume pulse A machine learning algorithm will immediately translate the physiological data into three basic emotions ie happy angryfearful sad represented by childrens choice of colors on the EIS A series of ANCOVA analyses will be used to determine the mean differences in self-regulation physiological and cognitive scores under baseline and treatment conditions
The EIS consists of two adjacent 3 x 5 sq ft wooden wall panels with colored LED lights creating a 90-degree semi-private space The adaptable colored lightings are controlled by a machine learning algorithm that is developed based on a co-investigators prior study The EIS harnesses the power of artificial intelligence to detect childrens emotions from physiological data in real-time and to translate physiological signals into environmental changes ie adaptable colored lighting that adequately respond to childrens emotions resulting in improved self-regulation physiological stress responses and cognitive performance
The objective of this proposal is to determine the effect of EIS on childrens age 3-6 self-regulation physiological and cognitive outcomes by employing a repeated ABAB experimental design A no intervention B EIS intervention The hypothesis is that EIS will positively impact childrens self-regulation physiological stress response and cognitive performance Based on a priori power analysis 40 preschool and kindergarten children will be recruited from early childhood programs in the rural areas near Moscow ID During the experiment children will be assessed under a combination of A and B conditions A digital wristband will capture childrens real-time physiological responses ie Galvanic skin response body temperature and blood volume pulse A machine learning algorithm will immediately translate the physiological data into three basic emotions ie happy angryfearful sad represented by childrens choice of colors on the EIS A series of ANCOVA analyses will be used to determine the mean differences in self-regulation physiological and cognitive scores under baseline and treatment conditions
Detailed Description:
Specific Aims
The percentage of young children living in the Mountain West MW rural areas is higher than the national average placing them at a greater risk of poorer health and education outcomes The proposed project aims to improve those young childrens self-regulation - a critical cognitive skill that underpins future mental health and academic outcomes Self-regulation has been studied as a promising treatment of various mental disorders such as depression and anxiety A longitudinal study indicates a strong association between kindergarten childrens self-regulation skill and their inhibitory control two decades later inhibitory control was indicated by substance abuse crimes and mental disorders The lack of inhibitory control is a prominent issue among adults in the MW region as suggested by a nation-wide longitudinal study with several MW states average scores ranked near the bottom in the US 7eg Idaho37 Wyoming46 Nevada50 Research also linked the early self-regulation skill to long-term academic achievement as shown in several early literacy and mathematics intervention studies further emphasizing an urgent need for interventions targeting self-regulation during a developmentally sensitive age period age 3-6 To reduce rural childrens health and education disparities we propose to test the effectiveness of an innovative intervention mechanism Emotive Intelligent Space EIS on childrens self-regulation physiological and cognitive outcomes
The EIS consists of two 3 x 5 sq ft wooden wall panels with LED lights creating a 90-degree semi-private space The adaptable colored lightings are controlled by a machine learning algorithm that is developed based on a co-investigators published prior research11 The EIS harnesses the power of artificial intelligence to detect childrens emotions from physiological data collected by a digital wristband in real-time and to translate these data into environmental changes ie adaptable colored lighting that adequately respond to childrens emotions1213 The colored lighting on the EIS is a developmentally appropriate intervention mechanism for young children age 3-6 for their non-invasive adaptive responsive and low-cost design
The purpose of this proposal is to determine the effect of the EIS on childrens behavioral physiological and cognitive outcomes using a quasi-experimental design Forty children in rural areas near Moscow ID will be recruited via existing collaborative relationships such as U of I research extension programs and Rural Sociology and Economics programs The EIS could potentially alleviate many challenges facing rural families with young children eg limited access to affordable quality health and education resources In the specific aims listed below childrens age gender and socioeconomic status SES will be included as covariates
Specific Aim 1 To determine whether EIS influences childrens self-regulation We hypothesize that children will demonstrate better self-regulation under the EIS condition than under the baseline condition
Specific Aim 2 To determine whether EIS impacts childrens physiological responses We hypothesize that children under the EIS condition will exhibit reduced stress responses eg Improved galvanic skin response body temperature and blood volume pulse as compared to their baseline scores
Specific Aim 3 To determine whether EIS affects childrens cognitive performance We hypothesize that children under the EIS color treatment will have better cognitive performance scores than their scores under the baseline condition
Research Strategy
Approach Participants Based on the priori power analysis described in a later section we will recruit 40 typically developing children 3-6 years old from local early childhood programs in the rural areas near Moscow ID where the University of Idaho U of I is located Preliminary testing will be conducted with the children in the Child Development Lab that is affiliated with the PIs home department All participants will undergo a color deficiency assessment ie Ishihara Color Vision Test to determine their eligibility
Setting The study will take place in the Ramsay Research Suite in the Niccolls Building on the U of I main campus The EIS will be securely installed in a corner of the research lab that is 20 feet 6 inches wide by 45 feet long with a ceiling height of 9 feet 9 inches The room has three windows on the east side and the window blinds are always closed to maintain the optimal temperature There are four round table and four chairs in the labs performance area The lab has white walls vinyl flooring and dim fluorescent lightings
The EIS our intervention mechanism consists of two double-layer wooden panels Each panel is 3 feet wide by 5 feet high and made from double layers of wood that allow colored LED lights to diffuse evenly through the panels The EIS will be placed on the left and front of participants creating a 90-degree semi-private space
Research Method A reversal within-group design ie ABAB method will be used During the first phase A a baseline and control will be established for the dependent variables - the level of child behavior under the natural lighting before the intervention is introduced If the dependent variables ie self-regulation physiological responses and cognitive performance changed with the introduction of the intervention and then returned to the baseline scores with the removal of the intervention we can conclude that there is strong evidence of a treatment effect The ABAB design greatly increases the internal validity of this project
Procedures Participating parents will contact the research team to schedule an initial meeting Day 1 where they will complete five tasks 1 Researchers will explain the research procedure 2 The participating childrens parents will sign informed consent forms and complete a demographic survey 3 Each child will undergo a color deficiency test to determine their eligibility for the study Eligible participants are typically developing children without color deficiencies 4 Eligible participants will select colors to represent three basic emotions sad happy and angryfearful among randomly arranged six colored cards red 5R 78 yellow 5Y 98 green 5G 78 blue 5B 68 purple 5P 78 and white N 95 representing the major color families in the Munsell color system which was used in a co-investigators previous study36 Each childs preferred colors will be used in their treatment conditions 5 Parents will schedule another appointment for the experiment
On the experiment day Day 2 a trained research assistant will first obtain the participating childs verbal assent The research assistant will then lead the child to the research lab describe the protocol and ask the child to wear a digital wristband and practice tasks while wearing the wristband At the beginning of each experiment condition the child will be asked to describe their current emotional status using a Q-sort a chart with faces representing different emotions to triangulate EIS emotion interpretation data To establish the baseline children complete tasks Head-Toes-Knees-Shoulders HTKS form A and Woodcock-Johnson-4 WJ-4 cognitive assessment form A which will take 5-7 minutes The HTKS task will be video recorded and used for self-regulation coding The child will then go to a different room to rest for 5 minutes while the research assistant stages the treatment condition ie program the child preferred colors in the computer For the next treatment condition children will return to the lab after a brief rest period and complete a parallel version of the two tasks completed under the baseline condition ie HTKS and WJ-4 form Bs to mitigate threats to internal validity with the presence of EIS Each child will repeat the same procedure with another set of baseline and intervention conditions The entire data collection session will last 30 to 40 minutes Light snacks will be available on-site for the children during rest periods Participants will receive a 40-dollar gift-card and bookstoys as incentives
Measures The impact of EIS on childrens self-regulation and cognitive performance will be assessed using multiple measures Three outcomes of this study include childrens self-regulation physiological responses and cognitive performance Each outcome will be measured under the baseline and treatment conditions These measurements are discussed under each specific aim as follows
Aim 1 To determine whether EIS influences childrens self-regulation controlling for gender age and socioeconomic status SES The outcome of Aim 1 self-regulation will be measured by the HTKS task which assesses a childs self-regulation This task requires cognitive skills such as inhibitory control attention and working memory Children will be asked to play a game where they must do the opposite of what the experimenter says It is a well-validated and reliable measure of self-regulation
Aim 2 To determine whether EIS impacts childrens physiological responses controlling for age gender and SES The outcome of Aim 2 physiological response will be measured by E4 Wristbands Physiological data ie Galvanic skin response body temperature blood volume pulse are gathered in real-time with a medical-grade wearable device ie E4 wristbands
Aim 3 To determine whether EIS affects childrens cognitive performance controlling for age gender and SES The outcome of Aim 3 cognitive performance will be measured by WJ-4 - Number Reversed subset WJ-4 is a brief age-appropriate and well-validated cognitive ability assessment that evaluates young childrens ability to retrieve and retain information required for ongoing cognitive processes
Covariates ie childrens age gender and SES will be measured with a demographic questionnaire SES will be calculated based on household annual income and parents highest education level The composite SES score will be calculated as the unweighted sum of the z scores ranging from -302 to 18
Statistical Analysis We will compare physiological self-regulation and cognitive mean scores under baseline and intervention conditions using repeated-measures ANCOVA We will test the null hypothesis that there is no difference in the dependent variables between time points 1-2 A-B 2-3 B-A and 3-4 A-B after controlling for the covariates ie childrens gender age and SES
The percentage of young children living in the Mountain West MW rural areas is higher than the national average placing them at a greater risk of poorer health and education outcomes The proposed project aims to improve those young childrens self-regulation - a critical cognitive skill that underpins future mental health and academic outcomes Self-regulation has been studied as a promising treatment of various mental disorders such as depression and anxiety A longitudinal study indicates a strong association between kindergarten childrens self-regulation skill and their inhibitory control two decades later inhibitory control was indicated by substance abuse crimes and mental disorders The lack of inhibitory control is a prominent issue among adults in the MW region as suggested by a nation-wide longitudinal study with several MW states average scores ranked near the bottom in the US 7eg Idaho37 Wyoming46 Nevada50 Research also linked the early self-regulation skill to long-term academic achievement as shown in several early literacy and mathematics intervention studies further emphasizing an urgent need for interventions targeting self-regulation during a developmentally sensitive age period age 3-6 To reduce rural childrens health and education disparities we propose to test the effectiveness of an innovative intervention mechanism Emotive Intelligent Space EIS on childrens self-regulation physiological and cognitive outcomes
The EIS consists of two 3 x 5 sq ft wooden wall panels with LED lights creating a 90-degree semi-private space The adaptable colored lightings are controlled by a machine learning algorithm that is developed based on a co-investigators published prior research11 The EIS harnesses the power of artificial intelligence to detect childrens emotions from physiological data collected by a digital wristband in real-time and to translate these data into environmental changes ie adaptable colored lighting that adequately respond to childrens emotions1213 The colored lighting on the EIS is a developmentally appropriate intervention mechanism for young children age 3-6 for their non-invasive adaptive responsive and low-cost design
The purpose of this proposal is to determine the effect of the EIS on childrens behavioral physiological and cognitive outcomes using a quasi-experimental design Forty children in rural areas near Moscow ID will be recruited via existing collaborative relationships such as U of I research extension programs and Rural Sociology and Economics programs The EIS could potentially alleviate many challenges facing rural families with young children eg limited access to affordable quality health and education resources In the specific aims listed below childrens age gender and socioeconomic status SES will be included as covariates
Specific Aim 1 To determine whether EIS influences childrens self-regulation We hypothesize that children will demonstrate better self-regulation under the EIS condition than under the baseline condition
Specific Aim 2 To determine whether EIS impacts childrens physiological responses We hypothesize that children under the EIS condition will exhibit reduced stress responses eg Improved galvanic skin response body temperature and blood volume pulse as compared to their baseline scores
Specific Aim 3 To determine whether EIS affects childrens cognitive performance We hypothesize that children under the EIS color treatment will have better cognitive performance scores than their scores under the baseline condition
Research Strategy
Approach Participants Based on the priori power analysis described in a later section we will recruit 40 typically developing children 3-6 years old from local early childhood programs in the rural areas near Moscow ID where the University of Idaho U of I is located Preliminary testing will be conducted with the children in the Child Development Lab that is affiliated with the PIs home department All participants will undergo a color deficiency assessment ie Ishihara Color Vision Test to determine their eligibility
Setting The study will take place in the Ramsay Research Suite in the Niccolls Building on the U of I main campus The EIS will be securely installed in a corner of the research lab that is 20 feet 6 inches wide by 45 feet long with a ceiling height of 9 feet 9 inches The room has three windows on the east side and the window blinds are always closed to maintain the optimal temperature There are four round table and four chairs in the labs performance area The lab has white walls vinyl flooring and dim fluorescent lightings
The EIS our intervention mechanism consists of two double-layer wooden panels Each panel is 3 feet wide by 5 feet high and made from double layers of wood that allow colored LED lights to diffuse evenly through the panels The EIS will be placed on the left and front of participants creating a 90-degree semi-private space
Research Method A reversal within-group design ie ABAB method will be used During the first phase A a baseline and control will be established for the dependent variables - the level of child behavior under the natural lighting before the intervention is introduced If the dependent variables ie self-regulation physiological responses and cognitive performance changed with the introduction of the intervention and then returned to the baseline scores with the removal of the intervention we can conclude that there is strong evidence of a treatment effect The ABAB design greatly increases the internal validity of this project
Procedures Participating parents will contact the research team to schedule an initial meeting Day 1 where they will complete five tasks 1 Researchers will explain the research procedure 2 The participating childrens parents will sign informed consent forms and complete a demographic survey 3 Each child will undergo a color deficiency test to determine their eligibility for the study Eligible participants are typically developing children without color deficiencies 4 Eligible participants will select colors to represent three basic emotions sad happy and angryfearful among randomly arranged six colored cards red 5R 78 yellow 5Y 98 green 5G 78 blue 5B 68 purple 5P 78 and white N 95 representing the major color families in the Munsell color system which was used in a co-investigators previous study36 Each childs preferred colors will be used in their treatment conditions 5 Parents will schedule another appointment for the experiment
On the experiment day Day 2 a trained research assistant will first obtain the participating childs verbal assent The research assistant will then lead the child to the research lab describe the protocol and ask the child to wear a digital wristband and practice tasks while wearing the wristband At the beginning of each experiment condition the child will be asked to describe their current emotional status using a Q-sort a chart with faces representing different emotions to triangulate EIS emotion interpretation data To establish the baseline children complete tasks Head-Toes-Knees-Shoulders HTKS form A and Woodcock-Johnson-4 WJ-4 cognitive assessment form A which will take 5-7 minutes The HTKS task will be video recorded and used for self-regulation coding The child will then go to a different room to rest for 5 minutes while the research assistant stages the treatment condition ie program the child preferred colors in the computer For the next treatment condition children will return to the lab after a brief rest period and complete a parallel version of the two tasks completed under the baseline condition ie HTKS and WJ-4 form Bs to mitigate threats to internal validity with the presence of EIS Each child will repeat the same procedure with another set of baseline and intervention conditions The entire data collection session will last 30 to 40 minutes Light snacks will be available on-site for the children during rest periods Participants will receive a 40-dollar gift-card and bookstoys as incentives
Measures The impact of EIS on childrens self-regulation and cognitive performance will be assessed using multiple measures Three outcomes of this study include childrens self-regulation physiological responses and cognitive performance Each outcome will be measured under the baseline and treatment conditions These measurements are discussed under each specific aim as follows
Aim 1 To determine whether EIS influences childrens self-regulation controlling for gender age and socioeconomic status SES The outcome of Aim 1 self-regulation will be measured by the HTKS task which assesses a childs self-regulation This task requires cognitive skills such as inhibitory control attention and working memory Children will be asked to play a game where they must do the opposite of what the experimenter says It is a well-validated and reliable measure of self-regulation
Aim 2 To determine whether EIS impacts childrens physiological responses controlling for age gender and SES The outcome of Aim 2 physiological response will be measured by E4 Wristbands Physiological data ie Galvanic skin response body temperature blood volume pulse are gathered in real-time with a medical-grade wearable device ie E4 wristbands
Aim 3 To determine whether EIS affects childrens cognitive performance controlling for age gender and SES The outcome of Aim 3 cognitive performance will be measured by WJ-4 - Number Reversed subset WJ-4 is a brief age-appropriate and well-validated cognitive ability assessment that evaluates young childrens ability to retrieve and retain information required for ongoing cognitive processes
Covariates ie childrens age gender and SES will be measured with a demographic questionnaire SES will be calculated based on household annual income and parents highest education level The composite SES score will be calculated as the unweighted sum of the z scores ranging from -302 to 18
Statistical Analysis We will compare physiological self-regulation and cognitive mean scores under baseline and intervention conditions using repeated-measures ANCOVA We will test the null hypothesis that there is no difference in the dependent variables between time points 1-2 A-B 2-3 B-A and 3-4 A-B after controlling for the covariates ie childrens gender age and SES
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None