Japi: Cognitive, Emotional and Social Stimulation for Preschool Children

NCT06420544 | Recruiting

• 1 other identifier: FONDEF ID22I10126
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Behavioral Problem of Child

Keywords

Executive Functions; Behavioral Problem; Children; Videogame; Non-cognitive skills; Cognitive skills

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Working Memory: Corsi Block Test

  through study completion, an average of 6 month

• Working Memory: Auditive Working Memory test

  through study completion, an average of 6 month

• Inhibitory control: The Hearts and Flowers task

  through study completion, an average of 6 month

• Emotion recognition: Assessment of Children's Emotions Skills

  through study completion, an average of 6 month

• Social competence: Challenging Situations Task

  through study completion, an average of 6 month

Study Arms (2)

Intervention group

EXPERIMENTAL

The whole intervention has 24 sessions. Children will play with the game two times a week, each lasting 15 minutes, over a period of 12 weeks. Each session stimulates two skills (one cognitive and one non-cognitive skills) and has eight activities with increasing levels of difficulty.

Behavioral: JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children

Control group

NO INTERVENTION

The control group receives standard school curricula, which is not a manualized intervention. The standard curriculum is provided by the Ministry of Education with a guideline called "Curricular Bases for Kindergarten Education" which includes pre-kindergarten directions to Early Year Educators regarding emotion regulation and planification to implement in class.

Interventions

JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children BEHAVIORAL

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.

Also known as: JAPI

Intervention group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• For students:
• \) Children attending pre-kindergarten
• Children with intellectual disability
• Children unable to understand and speak Spanish

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• University of Talca: collaborator

Study Sites (2)

Universidad de los Andes

Santiago, Santiago Metropolitan, 7620086, Chile

RECRUITING

Universidad de los Andes

Santiago, Santiago Metropolitan, Chile

RECRUITING

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MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Jorge Gaete, MD, PhD

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Gaete, MD, PhD

CONTACT

+56226181000; jgaete@uandes.cl

Natalia Ríos, BA

CONTACT

+56978783002; nmrios@miuandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study and until five years after the end of the study.
• Access Criteria: Any researchers who ask the principal investigator fot secondary analysis, data anonymized.

Locations

CL (2)