Development, Usability and Feasibility Pilot Study of a Videogame

NCT07048119 | Completed

• 1 other identifier: UAN 201701
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cognitive skills; Non-cognitive skills; Mental health; Preschoolers; Video game

Outcome Measures

Primary Outcomes (9)

• Functionality of video game: Mechanical errors

  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.

  Through study completion, an average of 1 year

• Functionality of video game: Failure to record data in the server

  The number of students whose data from video game play was not recorded in the server.

  Through study completion, an average of 1 year

• Poor student engagement

  Percentage of students who lack attention and engagement and prematurely stop playing, making them unable to finish the tasks and activities during each session.

  Through study completion, an average of 1 year

• Feasibility: number of eligible schools

  The number of eligible schools, those contacted, and those who agreed to participate.

  Through study completion, an average of 1 year

• Feasibility: Participant recruitment

  The number of parents/caregivers and students who were contacted and those who consented and agreed to participate.

  Through study completion, an average of 1 year

• Feasibility: Attrition

  The number of participants' losses during the study.

  Through study completion, an average of 1 year

• Feasibility: Intervention duration

  Data will be collected on the time needed to complete the intervention.

  Through study completion, an average of 1 year

• Feasibility: Time requirement needed for measurements

  Time invested in baseline and after-intervention measurements.

  Through study completion, an average of 1 year

• Feasibility: Student attandance

  We will collect student attendance data by session to play with Japi 1.0.

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Working Memory: Corsi Block Test

  Through study completion, an average of 1 year

• Working Memory: Woodcock- Muñoz Auditive Working Memory test

  Through study completion, an average of 1 year

• Inhibitory control: The Hearts and Flowers task

  Through study completion, an average of 1 year

• Executive function: The Minnesota Executive Function Scale (MEFS)

  Through study completion, an average of 1 year

• Emotion recognition: Assessment of Children's Emotions Skills (ACES)

  Through study completion, an average of 1 year

Study Arms (2)

Japi 1.0 Intervention

EXPERIMENTAL

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.

Behavioral: Japi 1.0

Control

NO INTERVENTION

The control group receives standard school curricula.

Interventions

Japi 1.0 BEHAVIORAL

The intervention has ten sessions, and two sessions of 30 minutes were delivered each week for 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.

Japi 1.0 Intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \- Children attending pre-kindergarten (aged around 4 years old).
• Children with intellectual disability.
• Children unable to understand and speak Spanish

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• King's College London: collaborator
• University of Talca: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, Las Condes, 7620086, Chile

Location

Related Publications (16)

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  BACKGROUND

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• Durlak JA, Weissberg RP, Dymnicki AB, Taylor RD, Schellinger KB. The impact of enhancing students' social and emotional learning: a meta-analysis of school-based universal interventions. Child Dev. 2011 Jan-Feb;82(1):405-32. doi: 10.1111/j.1467-8624.2010.01564.x.

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• GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.

  PMID: 35026139 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Jorge E Gaete, MD. PhD.

  Universidad de Los Andes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician was blinded to the group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Intervention versus Treatment as Usual

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: July 2, 2025
• Study Start: March 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)