Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420544
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-14
Brief Title:
Japi Cognitive Emotional and Social Stimulation for Preschool Children
Sponsor:
Universidad de los Andes Chile
Organization:
Universidad de los Andes Chile
Study Overview
Official Title:
Japi Cognitive Emotional and Social Stimulation for Preschool Children
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Japi
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 82 with conduct problems 70 peer problems 66 and hyperactivity-inattention 63 among the most prevalent In this study emotional problems reached 47 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
A study in China found that the prevalence of the total difficulties was 82 with conduct problems 70 peer problems 66 and hyperactivity-inattention 63 among the most prevalent In this study emotional problems reached 47 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 252 95 Confidence Interval CI 212-297 of youth globally are experiencing clinically elevated depression symptoms while 205 95 CI 172-244 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 82 with conduct problems 70 peer problems 66 and hyperactivity-inattention 63 among the most prevalent In this study emotional problems reached 47 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 Worlds Children 2021 UNICEFs 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 HighScope 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 persons 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 childrens 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
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 252 95 Confidence Interval CI 212-297 of youth globally are experiencing clinically elevated depression symptoms while 205 95 CI 172-244 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 82 with conduct problems 70 peer problems 66 and hyperactivity-inattention 63 among the most prevalent In this study emotional problems reached 47 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 Worlds Children 2021 UNICEFs 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 HighScope 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 persons 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 childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None