Japi: Cognitive, Emotional and Social Stimulation for Preschool Children

Behavioral Problem of Child Clinical Trial

— Japi  

Official title:

Japi: Cognitive, Emotional and Social Stimulation for Preschool Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420544
• Other study ID #: FONDEF ID22I10126
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Universidad de los Andes, Chile
• Contact: Jorge Gaete, MD, PhD
• Phone: +56226181000
• Email: jgaete[@]uandes.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mental health disorders are one of the leading causes of illness globally, and their relevance is expected to increase. Low and Middle Income Countries (LMIC), already facing psychological and behavioral issues due to chronic adversity, were further impacted during the COVID-19 pandemic. A study showed that symptoms of depression and anxiety in youth doubled during the first year of the pandemic compared to the pre-pandemic period.

A study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable.

The importance of psychosocial skills acquired in early childhood, such as emotional regulation and social problem-solving, for preventing mental disorders was highlighted. Studies indicate that the development of executive functions and non-cognitive skills in early childhood has a positive impact on long-term health and economic productivity.

However, the treatment gap for mental disorders in LMIC is significant, with only one in ten affected receiving treatment. Preventive interventions are needed, particularly in early childhood, to improve cognitive and socio-emotional skills.

Objective: The research proposal aims to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving functional and performance outcomes later in life.

Outcomes: Acceptability; Feasibility; Cognitive and non-cognitive skills; Working Memory; Inhibitory control; Emotion recognition; Social competence; Behavioral problems and psychological assessment.

Description:

Problem and opportunity:

Mental health disorders are among the leading causes of the Global Burden of Disease, and their relative importance is predicted to rise globally. Adversity is one of the most important risk factors associated with an increased incidence of psychological and behavioral problems. Acute or chronic adversity is common in Low and Middle Income Countries (LMIC) settings and unsurprisingly, psychological and behavioral problems are highly prevalent in LMIC, which have to deal with these emerging problems with scarce resources. During the COVID-19 pandemic, this scenario has worsened globally. One recent systematic review has showed that pooled estimates obtained in the first year of the COVID-19 pandemic suggest that 25.2% (95% Confidence Interval (CI), 21.2%-29.7%) of youth globally are experiencing clinically elevated depression symptoms, while 20.5% (95% CI, 17.2%-24.4%) of youth are experiencing clinically elevated anxiety symptoms. These pooled estimates, which increased over time, are double of pre pandemic estimates. And regarding behavioral problems, a study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable. The State of the World's Children 2021, UNICEF's most comprehensive look at the mental health of children in the 21st century, calls on "urgent investment in child and adolescent mental health across sectors, not just in health, to support a whole-of-society approach to prevention, promotion and care" and "integrating and scaling up evidence-based interventions across health, education and social protection sectors […]; and ensuring schools support mental health through quality services and positive relationships".

Along with the magnitude of the problem, the treatment gap for mental health disorders is large: one in every ten people with mental disorders receives treatment in LMIC. The ideal strategy to tackle this gap should be that of preventing the onset of these conditions. Most adult mental disorders start in childhood or adolescence, and delaying or preventing the onset can have a substantial impact. However, few preventive interventions or interventions to increase resilience to adversity have been developed, and even fewer tested in LMIC. There is evidence to suggest that strengthening cognitive and socio-emotional skills might result in a reduced incidence of mental disorders. For instance, reduced emotional regulation, and poor social problem-solving have been associated with increased incidence of depression.

Basic psychological skills acquired early in life have been associated with a range of important social and economic outcomes later in life. Early childhood is a critical time for psychosocial development. Until recently, years of education and Intelligence Quotient (IQ) were the main measures to assess the relationship between human capital and economic development. More recently, researchers have acknowledged that skills such as maintaining good interpersonal relations, controlling impulses, or demonstrating goal-directed behavior are critical to physical and mental health and economic productivity. The Nobel prize economist, James Heckman, highlighted the importance of these skills, which he originally called non-cognitive skills, for economic development. Scientific evidence has recently indicated that the stimulation of cognitive and non-cognitive skills in the first years of life promotes general development and has a beneficial long-term impact on health and on different economic indicators . However, much of this evidence comes from studies in the United States, Europe of other develop countries, such as the High/Scope Perry Preschool Study, the Abecedarian Project , Head Start, and Early Head Start. Many of these interventions were costly and difficult to implement.

Several studies have investigated how the capacity to regulate emotions and behaviors is associated with social, health, educational, and labor outcomes. Studies from neurobiology to behavioral economics show that emotions affect a person's ability to self-regulate and that this, in turn, affects cognitive skills and subsequent self-regulatory capacity. Executive functions, involving the regulation and control of cognitive processes, are closely linked to skills leading to better problem solving, task persistence, self-esteem, school performance, and better social adjustment with a reduction in aggressive and other behavioral problems. Healthy development of executive functions early in life predicts better self-regulatory capacity later. The growing scientific knowledge-based emotional self-regulation or social skills linked to the developing brain can be leveraged to engender new intervention approaches. There is significant evidence that structural and functional plasticity in many brain core centers involved in executive functions and self-regulatory processes develops rapidly during early childhood. Most of the evidence to support the association between early acquired psychosocial skills and functional outcomes later in life comes from developed countries. There is a need to replicate these findings in resource-poor settings.

In addition, the evidence suggests that children from low-income families may begin the preschool stage with less development of academic (such as pre-calculus and initial language) and non-academic skills (such as emotional, social, and health competence in general) when compared with children from higher-income families. These differences would contribute to the increase in socio-emotional, educational, and health disparities in the long term. Add to this the evidence that critical aspects of human development occur between 3 and 7 years, such as the recognition of emotions, the control of behavior, and the development of Executive Functions, it is essential to work with children who have greater economic vulnerability and to stimulate these skills early.

As our approaches become more interdisciplinary, several important questions arise: What is the effect of improving psychosocial skills on health, educational, and economic outcomes? What interventions are most effective at bolstering these functions and abilities? What is the applicability of such interventions across diverse cultural groups and in low-resource settings? Valid and reliable measures to assess these skills are lacking, especially for use in less developed countries. Furthermore, it would be important to incorporate more objective neurocognitive and physiological variables into the study of these regulatory processes. A concerted effort is needed to identify these critical psychosocial skills that can be incorporated into interventions to improve children's wellbeing globally. Multi-disciplinary research efforts can advance our understanding of these essential elements of human capital formation and their role in social and economic success in diverse settings.

The penetration of new technologies (smartphones, tablets, wearable devices) is increasing all over the world and opening unimaginable opportunities to advance this field, especially due to the effect of the covid-19 pandemic. Technological platforms offer an incredible opportunity to reach out to underserved and remotely located populations. The use of smartphones and tablets is increasing at a fast speed in most LMIC. These devices allow us to use more sophisticated software as well as all 'old' functionalities such as text messaging or live telephony. Gaming offers an excellent opportunity to engage young kids and deliver early life interventions at a low cost and at a large scale. The use of games in the educational sector is wide and continues to grow. There is good evidence that the use of technology among pre-school kids is feasible and growing. There are already recommendations of the features that apps need to have to promote learning and creativity. No other tablet games for young children are known that aim to stimulate multiple skills (working memory or inhibitory control, self-regulation, and social problem solving) with a single unified game. Other than teaching skills, technology might also allow capturing large amounts of data, which can help at the same time with one piece of software us understand better the mechanisms whereby skills are learned and the pathways to larger impact later in life. If these interventions effectively strengthen skills vital to improve health, social, and economic outcomes, the gains for society could be substantial. A large number of applications have been launched, though very few tested, to prevent mental disorders or behavioral problems. However, there is a marked paucity in the development of preventive interventions delivered via technology, especially early in life. There are a few games to foster specific psychosocial skills among pre-school children but comprehensive platforms that stimulate diverse functions, such as working memory, inhibitory control, emotion recognition or social competence, are not available.

Latin America has been a leading region pioneering initiatives aiming to stimulate basic psychosocial skills early in life. In Chile, programs to encourage mothers to stimulate the psychosocial skills of their children started in the seventies but the initial interest somehow lost impetus for political and economic reasons. More recently, as part of a major World Bank project in which members of our group participated, parents of low socioeconomic status were trained to improve the skills of their young children (aged <=5). Our group also undertook a large Randomized Controlled Trail (RCT) of a mental health school intervention for adolescents. One of the main lessons of this study was the need to focus on interventions at earlier ages to prevent rather than treat mental health problems. There is also evidence from other Chilean school programs that psychosocial skills are associated with better educational outcomes. Overall, there is consensus that in spite of the importance of the topic, there has been little research from LMICs. This proposal brings together a wide range of expertise across multiple disciplines including psychology, neuroscience, epidemiology, intervention trials, education, and economics. New methods and technologies are also being incorporated into this proposal. Developing effective early life interventions and assessing the mechanisms leading to changes using top-of-the-range, non-invasive technology are key features of this proposal. The results of this research will lay the foundations for future programs to learn how young children acquire skills, how the developing brain works, whether or not these skills predict future outcomes, and how these interventions can be scaled up.

Pandemic effect on tech use:

The digital revolution is evolving with an unprecedented explosion of technology development to transform mental health care delivery, with its emphasis on computing power and mobile technology. These platforms are becoming the medium through which assessment and intervention are taking place. The COVID-19 crisis has fast forwarded the use of technology in mental health care; therefore, it is crucial to scale up access to mental health interventions during and after COVID-19.

Taking all into account, the general objective of this study is to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving mental health and functional and performance outcomes later in life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

For schools:

Inclusion criteria:

1. Schools located in Santiago (Chile).

2. Schools with Preschool Education.

3. Mixed-sex schools.

4. Schools with vulnerability (=75%), measured with the School Vulnerability Index - National System of Equality Allocation (IVE-SINAE). This index is the proportion of students in a given school with high vulnerability. This index considers the following socioeconomic variables to group the schools: mother's educational level, father's educational level, and total monthly household income, among others.

Exclusion criteria:

1. Three or more classes in Preschool. This criterion was considered for economic and practical reasons.

2. Implementing a manualized program to promote cognitive or social-emotional skills.

3. Participating in a similar study.

For students:

Inclusion criteria:

1) Children attending pre-kindergarten

Exclusion criteria:

1. Children with intellectual disability

2. Children unable to understand and speak Spanish

Related Conditions & MeSH terms

• Behavioral Problem of Child
• Problem Behavior

Intervention

Behavioral:
• JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children
Those children in the intervention group will play with the gaming platform "Japi" using a tablet device in a designated time given from schools' authorities. Early Year Educators will be present to help with the discipline and motivation of the students and Research Assistants will be there as well to provide technical support for the use of the equipment. The intervention has 24 sessions, and the dosage will be two sessions of 15 minutes each per week for 12 weeks. Sessions number 1 to number 8 are focused on emotional regulation and inhibitory control. Sessions number 9 to 16 work on working memory and problem-solving. Sessions number 17 to 24 promote empathy and planification skills. Each session will have eight activities with increasing levels of difficulty.

Locations

Country	Name	City	State
Chile	Universidad de los Andes	Santiago	Metropolitana
Chile	Universidad de los Andes	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile	University of Talca

Country where clinical trial is conducted

Chile, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability: Early Year Educators	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?").	through study completion, an average of 6 month
Primary	Acceptability: Students	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.	through study completion, an average of 6 month
Primary	Feasibility of the intervention: Recruitment	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.	through study completion, an average of 6 month
Primary	Feasibility of the intervention: Assesment parameters	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.	through study completion, an average of 6 month
Primary	Feasibility of the intervention: Progress on the videogame	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.	through study completion, an average of 6 month
Secondary	Working Memory: Corsi Block Test	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.	through study completion, an average of 6 month
Secondary	Working Memory: Auditive Working Memory test	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.	through study completion, an average of 6 month
Secondary	Inhibitory control: The Hearts and Flowers task	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.	through study completion, an average of 6 month
Secondary	Emotion recognition: Assessment of Children's Emotions Skills	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.	through study completion, an average of 6 month
Secondary	Social competence: Challenging Situations Task	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.	through study completion, an average of 6 month
Secondary	Social competence: The Social Competence Scale - Parent Version	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.	through study completion, an average of 6 month
Secondary	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 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.	through study completion, an average of 6 month
Secondary	Behavioral problems and psychological assessment: The Eyberg Child Behavior Inventory (ECBI)	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.	through study completion, an average of 6 month
Secondary	Empathy Scale for Children	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.	through study completion, an average of 6 month
Secondary	The Tower of London	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.	through study completion, an average of 6 month