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Clinical Trials/NCT06420544
NCT06420544RecruitingNot Applicable

Japi: Cognitive, Emotional and Social Stimulation for Preschool Children

Universidad de los Andes, Chile2 sites in 1 country120 target enrollmentStarted: June 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
2
Primary Endpoint
Acceptability: Early Year Educators

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
3 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Acceptability: Early Year Educators

Time Frame: 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?").

Feasibility of the intervention: Assesment parameters

Time Frame: 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.

Acceptability: Students

Time Frame: 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.

Feasibility of the intervention: Recruitment

Time Frame: 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.

Feasibility of the intervention: Progress on the videogame

Time Frame: 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.

Secondary Outcomes

  • Emotion recognition: Assessment of Children's Emotions Skills(through study completion, an average of 6 month)
  • Working Memory: Corsi Block Test(through study completion, an average of 6 month)
  • Inhibitory control: The Hearts and Flowers task(through study completion, an average of 6 month)
  • Social competence: The Social Competence Scale - Parent Version(through study completion, an average of 6 month)
  • The Tower of London(through study completion, an average of 6 month)
  • Social competence: Challenging Situations Task(through study completion, an average of 6 month)
  • Behavioral problems and psychological assessment: The Eyberg Child Behavior Inventory (ECBI)(through study completion, an average of 6 month)
  • Empathy Scale for Children(through study completion, an average of 6 month)
  • Working Memory: Auditive Working Memory test(through study completion, an average of 6 month)
  • Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire (SDQ).(through study completion, an average of 6 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jorge Gaete

Principal Investigator

Universidad de los Andes, Chile

Study Sites (2)

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