Japi: Cognitive, Emotional and Social Stimulation for Preschool Children
NCT06420544, Not applicable, Unknown, Universidad de los Andes, Chile
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Japi: Cognitive, Emotional and Social Stimulation for Preschool Children | ClinicalTrials.gov |
| NCT number | NCT06420544 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidad de los Andes, Chile | ClinicalTrials.gov |
| Conditions | Behavioral Problem of Child | ClinicalTrials.gov |
| Interventions | JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children | ClinicalTrials.gov |
| First posted | 2024-05-20 | ClinicalTrials.gov |
| Last updated | 2024-06-14 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Acceptability: Early Year Educators | through study completion, an average of 6 month | Acceptability will be evaluated using one questionnaire that will be answered every week by the Early Year Educators (EYE). It will include questions regarding the fidelity of the implementation (e.g. "How many sessions children were able to play during the week?" "Be the panel to know the progress of the children?" "How many minutes were used to support each child during the week?", "Was the activity in this session interesting/relevant?" They also ask about the things they liked about the sessions and what they would change; and specifically, for EYE: "was feedback given to parents to promote the use of the gaming platform?"). The team will also solicit feedback on possible changes to be included in the future (e.g. "Is there anything that would be changed/replaced/included?"). | ClinicalTrials.gov |
| Primary | Acceptability: Students | through study completion, an average of 6 month | A brief assisted survey will also be carried out on the students, carried out in the middle and at the end of the intervention to assess if a children liked the intervention. | ClinicalTrials.gov |
| Primary | Feasibility of the intervention: Recruitment | through study completion, an average of 6 month | Data will be collected on the number of schools that are eligible, those that are contacted, and those that agree to participate. Data will also be collected on the number of students, parents, and Educators contacted and those who consent and agree to participate. | ClinicalTrials.gov |
| Primary | Feasibility of the intervention: Assesment parameters | through study completion, an average of 6 month | Data will also be collected on the time needed to complete the questionnaires and student assessment tests, and the loss of participants during follow-up. | ClinicalTrials.gov |
| Primary | Feasibility of the intervention: Progress on the videogame | through study completion, an average of 6 month | Automated data on the use of the game (number of sessions played, activities completed and level reached) will be captured via a server in those 3 schools with intense EYE support. | ClinicalTrials.gov |
| Secondary | Working Memory: Corsi Block Test | through study completion, an average of 6 month | This test assesses visuo-spatial short-term working memory. It involves repeating a sequence of up to nine identical spatially separated blocks on a screen. The sequence starts out simple but becomes more complex until the subject's performance begins to decline. This number is known as the Corsi Span. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | Working Memory: Auditive Working Memory test | through study completion, an average of 6 month | A sequence of audio messages of increased difficulty is presented, and the child is requested to remember these messages. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | Inhibitory control: The Hearts and Flowers task | through study completion, an average of 6 month | The Hearts and Flowers task is a hybrid combining elements of Simon and spatial Stroop tasks. For congruent trials, subjects are to obey the rule, "Press on the same side as the stimulus (Hearts)." For incongruent trials, subjects are to follow the rule, "Press on the side opposite the stimulus (Flowers)." It requires working memory and inhibition control. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | Emotion recognition: Assessment of Children's Emotions Skills | through study completion, an average of 6 month | It consists of facial expressions task aiming to evaluate emotion expression knowledge and whether the subjects exhibit any anger bias. The 26-item scale consists of colour photographs of ethnically diverse elementary schoolchildren depicting four expressions of each 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, and the anger bias score is the percentage of time the children incorrectly identify the faces as displaying anger. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | Social competence: Challenging Situations Task | through study completion, an average of 6 month | This instrument evaluates the ability of children to solve social problems. The children are presented 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 \[this situation\] happens. Then four pictures of behavioral responses (prosocial, aggressive, manipulation of others' feelings, and avoidant) are presented in random order and the child is asked "What 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 score the better the skill. | ClinicalTrials.gov |
| Secondary | Social competence: The Social Competence Scale - Parent Version | through study completion, an average of 6 month | Is a 12-item measure that assesses a child's prosocial behaviors, communication skills, and self control.Each item on this Scale states a behavior that a child may display in a social setting. The parent assesses how well each statement describes the child. Responses are coded on a five-point Likert scale ranging from zero (Not at all) to 4 (Very Well). The Scale contains two subscales: Prosocial/Communication Skills (Items 4, 7, 9, 10, 11 and 12) and Emotional Regulation Skills (Items 1, 2, 3, 5, 6, and 8). In addition to the subscale scores, a total score on the 12 items is also reported. T-tests of means for subscale scores and for the total score on this Scale show significant differences between the normative and control groups. The internal consistency measure (Cronbach alpha values) indicates that the total score and subscale scores are useful. | ClinicalTrials.gov |
| Secondary | Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire (SDQ). | through study completion, an average of 6 month | 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 difficulties that children may have and may be grouped together in a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviours in relationships with others. Each item is answered on a scale of responses from 1=not true to 3=absolutely true. There is a version for Educators, parents (to evaluate children from 4 to 16 years old), and a self-report for teenagers (ages 11 to 16 years old). It has been widely used and has shown good psychometric characteristics. The Educators' and parents' version of this instrument will be used. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | Behavioral problems and psychological assessment: The Eyberg Child Behavior Inventory (ECBI) | through study completion, an average of 6 month | The ECBI is a behaviorally specific rating scale that assesses the current frequency and severity of disruptive behaviors in the home setting, as well as the extent to which parents find the behavior troublesome. By evaluating the variety and frequency of behaviors commonly exhibited by all children, the instrument distinguishes normal behavior problems from conduct-disordered behavior in children and adolescents. This instrument requires the project pay a license per each time it is responded. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | Empathy Scale for Children | through study completion, an average of 6 month | Empathy Scale for Children (ESC) is a tool which is developed for measuring children's empathic skills. The scale consists of picture cards about four basic emotions (happiness, sadness, anger and fear) and cards about facial expressions. The higher score the better the skill. | ClinicalTrials.gov |
| Secondary | The Tower of London | through study completion, an average of 6 month | Its objective is to evaluate cognitive planning. The Tower of London was developed by Shallice (1982), based on the pre-existing Tower of Hanoi. This instrument is applied to children through individual interviews. The participants' task is to convert the initial position of the balls to the position demonstrated by the evaluator. Ball movements are limited by the fact that pegs differ in terms of the maximum number of balls they can hold at any time, and participants cannot move more than one ball at a time. The higher score the better the 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 36
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 1556286 | BACKGROUND | PubMed |
| 6452149 | BACKGROUND | PubMed |
| 8669519 | BACKGROUND | PubMed |
| 10086398 | BACKGROUND | PubMed |
| 12788263 | BACKGROUND | PubMed |
| 15493702 | BACKGROUND | PubMed |
| 15493705 | BACKGROUND | PubMed |
| 15547059 | BACKGROUND | PubMed |
| 16173857 | BACKGROUND | PubMed |
| 17666437 | BACKGROUND | PubMed |
| 18261193 | BACKGROUND | PubMed |
| 18657569 | BACKGROUND | PubMed |
| 19553062 | BACKGROUND | PubMed |
| 19919595 | BACKGROUND | PubMed |
| 20080363 | BACKGROUND | PubMed |
| 21328041 | BACKGROUND | PubMed |
| 21567214 | BACKGROUND | PubMed |
| 21722030 | BACKGROUND | PubMed |
| 21755376 | BACKGROUND | PubMed |
| 22023559 | 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 6
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 |
| Tower Planning | Secondary outcome | ConductCognition |
| Tower of Hanoi | 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)