Mental Health IssueJapi-1NCT07048119
Development, Usability and Feasibility Pilot Study of a Videogame
A study testing Japi 1.0 in people with Mental Health Issue and Development, Child, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Development, Child, Cognitive Ability, General
- What is being tested?
- Japi 1.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2018to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Children attending pre-kindergarten (aged around 4 years old).
Who cannot join
- 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 with intellectual disability.
- Children unable to understand and speak Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Usability and Feasibility Pilot Study of a Videogame Aiming to Stimulate Cognitive and Non-cognitive Skills Among Low-income Preschoolers in Chile
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.
Read the 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.
- Being tested
- Japi 1.0
- Keywords
- Cognitive skills, Non-cognitive skills, Mental health, Preschoolers, Video game
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japi 1.0Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Japi 1.0 |
| Control | No intervention | The control group receives standard school curricula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Feasibility: Attrition
The number of participants' losses during the study.
Measured: Through study completion, an average of 1 year
Feasibility: Intervention duration
Data will be collected on the time needed to complete the intervention.
Measured: Through study completion, an average of 1 year
Feasibility: Time requirement needed for measurements
Time invested in baseline and after-intervention measurements.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Working Memory: Corsi Block Test
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.
Measured: Through study completion, an average of 1 year
Working Memory: Woodcock- Muñoz Auditive Working Memory test
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.
Measured: Through study completion, an average of 1 year
Inhibitory control: The Hearts and Flowers task
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.
Measured: Through study completion, an average of 1 year
Executive function: The Minnesota Executive Function Scale (MEFS)
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.
Measured: Through study completion, an average of 1 year
Emotion recognition: Assessment of Children's Emotions Skills (ACES)
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.
Measured: Through study completion, an average of 1 year
Social competence: Challenging Situations Task (CST)
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.
Measured: Through study completion, an average of 1 year
Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire (SDQ).
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Mar 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus Treatment as Usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Talca
- Responsible party
- Principal investigator, Jorge Gaete, Universidad de los Andes, Chile
- Investigators
- Jorge E Gaete, MD. PhD., Study director, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048119
- Sponsor's protocol ID
- UAN 201701
- Acronym
- Japi-1
- Status last verified
- Jun 2025
- First submitted
- 26 Feb 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations, however tha data as a whole will be available on request to the Principal Investigator.
Publications
Carlson S, Zelazo P. Minnesota executive function scale: Test manual. Saint Paul, MN: Reflection Sciences. 2014.
Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
PubMed 11699809Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
PubMed 9255702Denham SA, Way E, Kalb SC, Warren-Khot HK, Bassett HH. Preschoolers' social information processing and early school success: the challenging situations task. Br J Dev Psychol. 2013 Jun;31(Pt 2):180-97. doi: 10.1111/j.2044-835X.2012.02085.x. Epub 2012 Sep 27.
PubMed 23659890Chung C, Choi S, Bae J, Jeong H, Lee J, Lee H. Developing and Validating a Korean Version of the Assessment of Children's Emotional Skills. Child Psychiatry Hum Dev. 2024 Jun;55(3):819-830. doi: 10.1007/s10578-022-01452-2. Epub 2022 Oct 13.
PubMed 36229629Davidson MC, Amso D, Anderson LC, Diamond A. Development of cognitive control and executive functions from 4 to 13 years: evidence from manipulations of memory, inhibition, and task switching. Neuropsychologia. 2006;44(11):2037-78. doi: 10.1016/j.neuropsychologia.2006.02.006. Epub 2006 Mar 31.
PubMed 16580701Gathercole SE, Willis CS, Baddeley AD, Emslie H. The Children's Test of Nonword Repetition: a test of phonological working memory. Memory. 1994 Jun;2(2):103-27. doi: 10.1080/09658219408258940.
PubMed 7584287Orsini A. Corsi's block-tapping test: standardization and concurrent validity with WISC-R for children aged 11 to 16. Percept Mot Skills. 1994 Dec;79(3 Pt 2):1547-54. doi: 10.2466/pms.1994.79.3f.1547.
PubMed 7870543Doyle O, Harmon CP, Heckman JJ, Tremblay RE. Investing in early human development: timing and economic efficiency. Econ Hum Biol. 2009 Mar;7(1):1-6. doi: 10.1016/j.ehb.2009.01.002. Epub 2009 Jan 21.
PubMed 19213617Campbell F, Conti G, Heckman JJ, Moon SH, Pinto R, Pungello E, Pan Y. Early childhood investments substantially boost adult health. Science. 2014 Mar 28;343(6178):1478-85. doi: 10.1126/science.1248429.
PubMed 24675955Bucci S, Schwannauer M, Berry N. The digital revolution and its impact on mental health care. Psychol Psychother. 2019 Jun;92(2):277-297. doi: 10.1111/papt.12222. Epub 2019 Mar 28.
PubMed 30924316Garon N, Bryson SE, Smith IM. Executive function in preschoolers: a review using an integrative framework. Psychol Bull. 2008 Jan;134(1):31-60. doi: 10.1037/0033-2909.134.1.31.
PubMed 18193994Berger A, Kofman O, Livneh U, Henik A. Multidisciplinary perspectives on attention and the development of self-regulation. Prog Neurobiol. 2007 Aug;82(5):256-86. doi: 10.1016/j.pneurobio.2007.06.004. Epub 2007 Jun 22.
PubMed 17651888Durlak 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.
PubMed 21291449Cunha F, Heckman J, Schennach S. Estimating the Technology of Cognitive and Noncognitive Skill Formation. Econometrica. 2010 May 1;78(3):883-931. doi: 10.3982/ECTA6551.
PubMed 20563300
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Usability and Feasibility Pilot Study of a Videogame Aiming to Stimulate Cognitive and Non-cognitive Skills Among Low-income Preschoolers in Chile
- ClinicalTrials.gov ID
- NCT07048119
- Acronym / sponsor ID
- Japi-1 / UAN 201701
- Keywords
- Cognitive skills, Non-cognitive skills, Mental health, Preschoolers, Video game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- King's College London, University of Talca
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus Treatment as Usual
| Arm | Type | Receives |
|---|---|---|
| Japi 1.0 Intervention | Experimental | Behavioral: Japi 1.0Video 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. |
| Control | No intervention | –The control group receives standard school curricula. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- Children attending pre-kindergarten (aged around 4 years old).
Key exclusion criteria (5 listed)
- 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 with intellectual disability.
- Children unable to understand and speak Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Japi 1.0The 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. | Behavioural | Japi 1.0 Intervention |
Primary outcome
Functionality of video game: Mechanical errors
Time frame: 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
Time frame: 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
Time frame: 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: number of eligible schools
Time frame: Through study completion, an average of 1 year
The number of eligible schools, those contacted, and those who agreed to participate.
Feasibility: Participant recruitment
Time frame: 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: Attrition
Time frame: Through study completion, an average of 1 year
The number of participants' losses during the study.
Feasibility: Intervention duration
Time frame: 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
Time frame: Through study completion, an average of 1 year
Time invested in baseline and after-intervention measurements.
Feasibility: Student attandance
Time frame: Through study completion, an average of 1 year
We will collect student attendance data by session to play with Japi 1.0.
7 secondary outcomes
Working Memory: Corsi Block Test
Time frame: Through study completion, an average of 1 year
Working Memory: Woodcock- Muñoz Auditive Working Memory test
Time frame: Through study completion, an average of 1 year
Inhibitory control: The Hearts and Flowers task
Time frame: Through study completion, an average of 1 year
Executive function: The Minnesota Executive Function Scale (MEFS)
Time frame: Through study completion, an average of 1 year
Emotion recognition: Assessment of Children's Emotions Skills (ACES)
Time frame: Through study completion, an average of 1 year
Social competence: Challenging Situations Task (CST)
Time frame: Through study completion, an average of 1 year
Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire (SDQ).
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- BackgroundCarlson S, Zelazo P. Minnesota executive function scale: Test manual. Saint Paul, MN: Reflection Sciences. 2014.
- Background: PubMed 11699809Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
- Background: PubMed 9255702Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Background: PubMed 23659890Denham SA, Way E, Kalb SC, Warren-Khot HK, Bassett HH. Preschoolers' social information processing and early school success: the challenging situations task. Br J Dev Psychol. 2013 Jun;31(Pt 2):180-97. doi: 10.1111/j.2044-835X.2012.02085.x. Epub 2012 Sep 27.
- Background: PubMed 36229629Chung C, Choi S, Bae J, Jeong H, Lee J, Lee H. Developing and Validating a Korean Version of the Assessment of Children's Emotional Skills. Child Psychiatry Hum Dev. 2024 Jun;55(3):819-830. doi: 10.1007/s10578-022-01452-2. Epub 2022 Oct 13.
- Background: PubMed 16580701Davidson MC, Amso D, Anderson LC, Diamond A. Development of cognitive control and executive functions from 4 to 13 years: evidence from manipulations of memory, inhibition, and task switching. Neuropsychologia. 2006;44(11):2037-78. doi: 10.1016/j.neuropsychologia.2006.02.006. Epub 2006 Mar 31.
- Background: PubMed 7584287Gathercole SE, Willis CS, Baddeley AD, Emslie H. The Children's Test of Nonword Repetition: a test of phonological working memory. Memory. 1994 Jun;2(2):103-27. doi: 10.1080/09658219408258940.
- Background: PubMed 7870543Orsini A. Corsi's block-tapping test: standardization and concurrent validity with WISC-R for children aged 11 to 16. Percept Mot Skills. 1994 Dec;79(3 Pt 2):1547-54. doi: 10.2466/pms.1994.79.3f.1547.
- Background: PubMed 19213617Doyle O, Harmon CP, Heckman JJ, Tremblay RE. Investing in early human development: timing and economic efficiency. Econ Hum Biol. 2009 Mar;7(1):1-6. doi: 10.1016/j.ehb.2009.01.002. Epub 2009 Jan 21.
- Background: PubMed 24675955Campbell F, Conti G, Heckman JJ, Moon SH, Pinto R, Pungello E, Pan Y. Early childhood investments substantially boost adult health. Science. 2014 Mar 28;343(6178):1478-85. doi: 10.1126/science.1248429.
- Background: PubMed 30924316Bucci S, Schwannauer M, Berry N. The digital revolution and its impact on mental health care. Psychol Psychother. 2019 Jun;92(2):277-297. doi: 10.1111/papt.12222. Epub 2019 Mar 28.
- Background: PubMed 18193994Garon N, Bryson SE, Smith IM. Executive function in preschoolers: a review using an integrative framework. Psychol Bull. 2008 Jan;134(1):31-60. doi: 10.1037/0033-2909.134.1.31.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations, however tha data as a whole will be available on request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge E Gaete, MD. PhD. study director
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Japi 1.0 in people with Mental Health Issue and Development, Child, run by Universidad de los Andes, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality of video game: Mechanical errors (time frame: Through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048119, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.