NCT04836286

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 children's self-regulation (i.e., 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-investigator's prior study. The EIS harnesses the power of artificial intelligence to detect children's emotions from physiological data in real-time and to translate physiological signals into environmental changes (i.e., adaptable colored lighting) that adequately respond to children's 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 children's (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 children's 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 children's real-time physiological responses (i.e., Galvanic skin response, body temperature, and blood volume pulse). A machine learning algorithm will immediately translate the physiological data into three basic emotions (i.e., happy, angry/fearful, sad) represented by children's 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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

First Submitted

Initial submission to the registry

November 16, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

November 16, 2020

Last Update Submit

November 2, 2022

Conditions

Keywords

Self-regulationColor-emotion associationCognitive performance

Outcome Measures

Primary Outcomes (5)

  • Self-regulation

    Self-regulation will be measured by the Head Toes Knees Shoulder task. This task measures cognitive skills such as inhibitory control, attention, and working memory, which are indicators of self-regulation. Children will be asked to play a game where they must do the opposite of what the experimenter says.

    10 minutes

  • Body temperature

    Body temperature will be measured in fahrenheit using the wristband.

    30 minutes

  • Galvanic skin response

    Skin Conductance (SC) will be measured as an indicator of the continuous variations in the electrical characteristics of the skin, using the wristband.

    30 minutes

  • Blood volume pulse

    Blood volume pulse will be measured as the number of heart beat per minutes, using the wristband.

    30 minutes

  • Cognitive performance

    This outcome will be measured with will be measured as working memory efficiency by the Woodcock Johnson Number Reversed subset. WJ-4 is a brief, age-appropriate, and well-validated cognitive ability assessment that evaluates young children's ability to retrieve and retain information required for ongoing cognitive processes.

    3 minutes

Study Arms (1)

single group repeated design

EXPERIMENTAL

The Emotive Intelligent Spaces (EIS) leverages innovations across multiple disciplines, including sensory environment, computer science, psychology, and real-time human-computer interface. The colors of the LED lights on the EIS wooden panels are controlled by an artificial intelligence computer algorithm that will translate children's physiological responses (Galvanic skin response, body temperature, and blood volume pulse), captured by a digital wristband, into their emotional state and the associated preferred colored lighting. The algorithm was created in a co-investigator's published study, using fuzzy logic and machine learning techniques (i.e., Decision Tree; accuracy 86%).To successfully carry out this project, our team blends expertise in educational psychology, early intervention, computer science, architecture, and interior design.

Behavioral: Emotive Intelligent Spaces (EIS)

Interventions

The EIS leverages innovations across multiple disciplines, including sensory environment, computer science, psychology, and real-time human-computer interface. The colors of the LED lights on the EIS wooden panels are controlled by an artificial intelligence computer algorithm that will translate children's physiological responses (Galvanic skin response, body temperature, and blood volume pulse), captured by a digital wristband, into their emotional state and the associated preferred colored lighting. The algorithm was created in a co-investigator's published study11, using fuzzy logic and machine learning techniques (i.e., Decision Tree; accuracy 86%).To successfully carry out this project, our team blends expertise in educational psychology, early intervention, computer science, architecture, and interior design.

single group repeated design

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Typically developing children without color blindness

You may not qualify if:

  • Children with color blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844, United States

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Shiyi Chen, PhD

    University of Idaho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: ABAB design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

April 8, 2021

Study Start

April 1, 2021

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Deidentified data can be shared upon researchers' request.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data will be available from August 2021. Data will be available for the foreseeable future.
Access Criteria
Data requester must have appropriate IRB approval. Data can only be used for research purposes.

Locations