Development, Usability and Feasibility Pilot Study of a Videogame
NCT07048119, Not applicable, Completed, Universidad de los Andes, Chile
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Development, Usability and Feasibility Pilot Study of a Videogame | ClinicalTrials.gov |
| NCT number | NCT07048119 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 317 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universidad de los Andes, Chile | ClinicalTrials.gov |
| Conditions | Mental Health Issue, Development, Child, Cognitive Ability, General | ClinicalTrials.gov |
| Interventions | Japi 1.0 | ClinicalTrials.gov |
| First posted | 2025-07-02 | ClinicalTrials.gov |
| Last updated | 2025-07-02 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | Feasibility: Attrition | Through study completion, an average of 1 year | The number of participants' losses during the study. | ClinicalTrials.gov |
| Primary | Feasibility: Intervention duration | Through study completion, an average of 1 year | Data will be collected on the time needed to complete the intervention. | ClinicalTrials.gov |
| Primary | Feasibility: Time requirement needed for measurements | Through study completion, an average of 1 year | Time invested in baseline and after-intervention measurements. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 15
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 7584287 | BACKGROUND | PubMed |
| 7870543 | BACKGROUND | PubMed |
| 9255702 | BACKGROUND | PubMed |
| 11699809 | BACKGROUND | PubMed |
| 16580701 | BACKGROUND | PubMed |
| 17651888 | BACKGROUND | PubMed |
| 18193994 | BACKGROUND | PubMed |
| 19213617 | BACKGROUND | PubMed |
| 20563300 | BACKGROUND | PubMed |
| 21291449 | BACKGROUND | PubMed |
| 23659890 | BACKGROUND | PubMed |
| 24675955 | BACKGROUND | PubMed |
| 30924316 | BACKGROUND | PubMed |
| 35026139 | BACKGROUND | PubMed |
| 36229629 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Hearts and Flowers Task | Secondary outcome | ConductCognition |
| Spatial Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)