Japi: Cognitive, Emotional and Social Stimulation for Preschool Children
ConditionBehavioral Problem of Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorUniversidad de los Andes, Chile
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Schools located in Santiago (Chile).
Schools with Preschool Education.
Mixed-sex schools.
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.
Disqualifiers
Three or more classes in Preschool. This criterion was considered for economic and practical reasons.
Implementing a manualized program to promote cognitive or social-emotional skills.
Participating in a similar study.
Children with intellectual disability
Trial design
Design model
Parallel
Treatments tested in this trial
JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children
BehavioralThose 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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?").
Time frame
through study completion, an average of 6 month2
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.
Time frame
through study completion, an average of 6 month3
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.
Time frame
through study completion, an average of 6 month4
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.
Time frame
through study completion, an average of 6 monthSecondary outcomes
1
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.
Time frame
through study completion, an average of 6 month2
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.
Time frame
through study completion, an average of 6 month3
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.
Time frame
through study completion, an average of 6 month4
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.
Time frame
through study completion, an average of 6 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de los Andes, Chile
Lead sponsor
University of Talca
Collaborator
Source ClinicalTrials.gov