Development, Usability and Feasibility Pilot Study of a Videogame (Japi-1)

Universidad de los Andes, Chile

Status: Completed

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

Treatments: Behavioral: Japi 1.0

Study type: Interventional

Funder types: Other

Identifiers

NCT07048119

UAN 201701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 317 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Schools:

• Schools located in Santiago (Chile).
• Schools with Preschool Education.
• Mixed-sex schools.
• Schools with high vulnerability (≥ 75%), as stated in the School Vulnerability Index - National System of Equality Allocation (IVE-SINAE). This index is the proportion of high-vulnerability students in a given school, considering socioeconomic variables such as the mother's educational level, the father's educational level, and total monthly household income, among others.

Exclusion Criteria Schools:

• Four or more classes in Preschool. This criterion was considered for economic and practical reasons.
• Implementing a manualized program to promote cognitive or social-emotional skills.
• Participating in a similar study.

Inclusion Criteria for Students:

• Children attending pre-kindergarten (aged around 4 years old).

Exclusion criteria for Students

• Children with intellectual disability.
• Children unable to understand and speak Spanish

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

317 participants in 2 patient groups

Japi 1.0 Intervention

Experimental group

Description:

Video game of 10 sessions with activities stimulating cognitive (working memory and inhibitory control) and non-cognitve (emotion recognition and social competence) skills. Children will play with the game two times a week, each lasting 30 minutes, over 5 weeks. Sessions numbers 1 to 5 were focused on emotional recognition and inhibitory control. Sessions numbers 6 to 10 worked on working memory and social competence. Each session had eight activities and five tasks per activity with increasing difficulty levels.

Treatment:

Behavioral: Japi 1.0

Control

No Intervention group

Description:

The control group receives standard school curricula.