Development, Usability and Feasibility Pilot Study of a Videogame

Not Applicable

Completed

• Conditions: Cognitive Ability, General; Mental Health Issue; Development, Child

• Registration Number: NCT07048119
• Lead Sponsor: Universidad de los Andes, Chile

Brief Summary

Mental health disorders are one of the leading causes of illness globally. The importance of psychosocial skills acquired in early childhood, such as executive functions, inhibitory control, emotional regulation, and social problem-solving, in preventing mental disorders has been reported. Furthermore, mental health care delivery is evolving, and mobile technology is becoming the medium for assessment and intervention. We developed Japi 1.0, a video game, to stimulate cognitive and non-cognitive skills in early childhood. This study aims to assess the functionality of this video game, student engagement and behavior, classroom climate, the feasibility of the implementation of the study and to explore the impact of the video game on the development of cognitive and non-cognitive skills.

Detailed Description

The use of technology in preventive interventions allows, on the one hand, the development of cost-effective strategies and, on the other, access to a large population. There are a number of therapeutic and preventive initiatives that have begun to be used in the mental health field in adolescents and adults. These interventions have been delivered through websites or mobile applications, and have shown some effectiveness. However, there are no studies on using these technologies in preschool populations. There is consensus in the scientific community that the stimulation of cognitive and non-cognitive skills in the first years of life promotes development in general and produces a beneficial impact in the long term on health and on different economic indicators.

The objectives of this research are: 1) To develop a video game prototype to be used on tablets by pre-kindergarten students from socio-economically vulnerable schools, which allows stimulating working memory, behavioral inhibition, emotion recognition, and social problem-solving skills in such a way as to prevent the development of behavioral problems and general psychological distress; 2) To carry out a pilot cluster Randomized Controlled Trial to evaluate several aspects of functionality of this video game, student engagement and behavior, classroom climate, the feasibility of the implementation of the study and to explore the impact of the video game on the development of cognitive and non-cognitive skills.

It is expected to recruit eight schools with at least one pre-kindergarten class, with an average of 30 students per class. Schools will be randomly allocated to intervention and control groups in a ratio of 1:1. The control group will receive their usual curricular activities. Meanwhile, the students in the intervention group will play the ten 30-minute video game sessions supervised by preschool teachers and research assistants. The frequency of sessions is expected to be twice a week for 5 weeks. Both groups will be evaluated at the beginning and after implementing Japi 1.0. The assessment will include the direct in-person measurement of working memory, behavioral inhibition, emotion recognition, and social problem-solving skills among children and evaluating children's emotional and behavioral problems rated by parents or caregivers. As the primary outcomes of this study are the evaluation of the functionality of this video game, student engagement, and behavior during playing, classroom climate, and the feasibility of the implementation of the study, the research team has developed quantitative and qualitative measures to collect this data.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-15
• Study First Submitted: 2025-02-26
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functionality of video game: Mechanical errors	Through study completion, an average of 1 year	The number of errors in the video game (e.g., wrong interface, stuck or frozen screen, wrong reward stimulus after students´ correct responses) registered for tasks and activities during sessions.
Functionality of video game: Failure to record data in the server	Through study completion, an average of 1 year	The number of students whose data from video game play was not recorded in the server.
Poor student engagement	Through study completion, an average of 1 year	Percentage of students who lack attention and engagement and prematurely stop playing, making them unable to finish the tasks and activities during each session.
Feasibility: Participant recruitment	Through study completion, an average of 1 year	The number of parents/caregivers and students who were contacted and those who consented and agreed to participate.
Feasibility: Student attandance	Through study completion, an average of 1 year	We will collect student attendance data by session to play with Japi 1.0.
Feasibility: number of eligible schools	Through study completion, an average of 1 year	The number of eligible schools, those contacted, and those who agreed to participate.
Feasibility: Attrition	Through study completion, an average of 1 year	The number of participants' losses during the study.
Feasibility: Intervention duration	Through study completion, an average of 1 year	Data will be collected on the time needed to complete the intervention.
Feasibility: Time requirement needed for measurements	Through study completion, an average of 1 year	Time invested in baseline and after-intervention measurements.

Secondary Outcome Measures

Name	Time	Method
Emotion recognition: Assessment of Children's Emotions Skills (ACES)	Through study completion, an average of 1 year	It consists of a facial expressions task aiming to evaluate emotion expression knowledge and whether the subjects exhibit any anger bias. The 26-item scale consists of color photographs of ethnically diverse elementary schoolchildren depicting four expressions of the four basic emotions (happy, sad, angry, and scared) and 10 images of children without obvious facial expressions. The examiner shows the child the photographs one at a time and each time asks, "Is the child in the picture happy, sad, angry, or scared?" Then, the examiner registers the child's answer. The emotion accuracy score reflects how many items the children answer correctly (16 points is the perfect score). The higher the score, the better the skill. Additionally, there is an anger bias score, which is the number of times the children incorrectly identify the faces as displaying anger. The higher the score, the higher the anger bias.
Social competence: Challenging Situations Task (CST)	Through study completion, an average of 1 year	This instrument evaluates the ability of children to solve social problems. The children are presented with six vignettes that describe problems between peers. Following the presentation of each challenging situation, four pictures of happy, sad, angry, and neutral affect are presented in random order. The child is asked to point to the picture that best describes how they feel when \[one of the situations\] happens. Then, four pictures of behavioral responses (prosocial, aggressive, disruptive, or less adaptative behavior \[cry\], and avoidant) are presented in random order, and the child is asked, "What do you do in this situation\]?" The answers are categorized into four possibilities: prosocial, aggressive, cry, and avoidant. Scores for affective and behavioral responses used are the number of times each affect, and each behavioral response is chosen by each child across the six situations. The higher the prosocial behavioral response score, the better the skill.
Working Memory: Corsi Block Test	Through study completion, an average of 1 year	This test assesses visuospatial short-term working memory. It involves repeating a sequence of up to nine identical spatially separated blocks on a screen. The sequence starts simple but becomes more complex until the subject's performance declines. This number is known as the Corsi Span. The higher the score, the better the skill.
Executive function: The Minnesota Executive Function Scale (MEFS)	Through study completion, an average of 1 year	This instrument evaluates executive functions, specifically cognitive flexibility, working memory, and inhibitory control, among individuals beginning at 24 months and extending throughout their lifespan. It is an adaptive virtual card-sorting task delivered on a tablet (4-minute average test duration). The higher the score, the better the skill.
Working Memory: Woodcock- Muñoz Auditive Working Memory test	Through study completion, an average of 1 year	A sequence of audio messages of words and numbers of increased difficulty is presented, and the child is requested to remember these sequences-the higher the score, the better the skill.
Inhibitory control: The Hearts and Flowers task	Through study completion, an average of 1 year	The Hearts and Flowers task combines elements of Simon and spatial Stroop tasks. Children must follow the rule for congruent trials: "Press on the same side as the stimulus (Hearts)." For incongruent trials, children must follow the rule: "Press on the side opposite the stimulus (Flowers)." It requires working memory and inhibition control. The higher the score, the better the skill.
Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire (SDQ).	Through study completion, an average of 1 year	This 25-question questionnaire explores different symptoms grouped into 5 sub-scales (with 5 items each): (1) emotional symptoms, (2) behavioral problems, (3) problems with peers, (4) symptoms of lack of attention and hyperactivity, and (5) prosocial skills. The first four sub-scales refer to children's difficulties and may be grouped into a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviors in relationships. Each item is answered on a scale of responses from 1=not true to 3=absolutely true. There is a version for Educators and parents (to evaluate children from 4 to 16 years old) and a self-report for teenagers (ages 11 to 16 years old). The Parents' version of this instrument will be used-the higher the score in the total difficulties sub-scale, the higher the behavior problems in the case of the prosocial sub-scale; the higher the score, the higher the prosocial skill.

Trial Locations

Locations (1)

Universidad de los Andes; 🇨🇱 Santiago, Las Condes, Chile