Clinical trial NCT06420544: Japi: Cognitive, Emotional and Social Stimulation for Preschool Children
Official title: Japi: Cognitive, Emotional and Social Stimulation for Preschool Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral Problem of Child
Keywords: Executive Functions
Behavioral Problem
Children
Videogame
Non-cognitive skills
Cognitive skills
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: University of Talca
First posted: 2024-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Acceptability, feasibility and efficacy of this intervention will be measured, including the measurement of outcomes (skill formation) compared with a 'placebo' control group among pre-school children from low socio-economic backgrounds in Santiago. A mixed-method design with a strong qualitative component to understand better the factors that might facilitate or interfere with the delivery and acceptability of this intervention will be conducted. At the start of the study there will be a mapping the structure of the schools, the locations, staff composition, characteristics of the children and families, and other contextual factors important for the successful implementation of the intervention.

Schools that fulfil the inclusion and exclusion criteria will be invited to participated. Six schools be selected and will be randomized and allocated in 1:1 proportion to intervention and control group.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability: Early Year Educators
timeFrame: through study completion, an average of 6 month
measure: Acceptability: Students
timeFrame: through study completion, an average of 6 month
measure: Feasibility of the intervention: Recruitment
timeFrame: through study completion, an average of 6 month
measure: Feasibility of the intervention: Assesment parameters
timeFrame: through study completion, an average of 6 month
measure: Feasibility of the intervention: Progress on the videogame
timeFrame: through study completion, an average of 6 month
Secondary outcomes:
measure: Working Memory: Corsi Block Test
timeFrame: through study completion, an average of 6 month
measure: Working Memory: Auditive Working Memory test
timeFrame: through study completion, an average of 6 month
measure: Inhibitory control: The Hearts and Flowers task
timeFrame: through study completion, an average of 6 month
measure: Emotion recognition: Assessment of Children's Emotions Skills
timeFrame: through study completion, an average of 6 month
measure: Social competence: Challenging Situations Task
timeFrame: through study completion, an average of 6 month
measure: Social competence: The Social Competence Scale - Parent Version
timeFrame: through study completion, an average of 6 month
measure: Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire (SDQ).
timeFrame: through study completion, an average of 6 month
measure: Behavioral problems and psychological assessment: The Eyberg Child Behavior Inventory (ECBI)
timeFrame: through study completion, an average of 6 month
measure: Empathy Scale for Children
timeFrame: through study completion, an average of 6 month
measure: The Tower of London
timeFrame: through study completion, an average of 6 month
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes
state: Metropolitana
city: Santiago
country: Chile
facility: Universidad de los Andes
state: Metropolitana
Study officials:
affiliation: Universidad de Los Andes
name: Jorge Gaete, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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