NCT06174467

Brief Summary

ABSTRACT- Introduction: Skills such as recognizing and managing emotions, developing empathy, building cooperative relationships, solving problems effectively and obtaining communication skills have gained importance in several schools and this has been made possible by Socio-Emotional Learning (SEL). Robust studies in this area in Latin America are lacking, and what happens in the brain and in our general physiology, from trainings related to SEL, needs to be better understood. Objectives: To assess the effects of Learning for Hearts and Minds Training (TACM) on positive and negative affect, empathy and compassion, emotional expression, self-compassion, life satisfaction, sense of community in the classroom, academic goals, school performance, brain activity and heart rate variability in 4th and 5th year elementary school students. Methods: This is a randomized controlled trial in clusters with cross-over, in approximately 600 students. By the end of the first semester, one group of students will receive the TACM and the other will be a waiting control group. In the second semester, the latter will receive the TACM and the former will continue the TACM practices. The groups will be evaluated in 5 moments during the year. A classroom will be randomly assigned to undergo an assessment of brain activity and cardiac variability to assess their ability to regulate emotions. Students, parents and teachers will be drawn for a qualitative interview at the end of the academic semesters about the effects of TACM.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

February 24, 2023

Last Update Submit

February 19, 2024

Conditions

Keywords

learningsocial-emotional learningemotion regulationprosocial behavior

Outcome Measures

Primary Outcomes (11)

  • Change in Positive and negative Affects scores

    they will answer the "Positive and Negative Affect Scale for Children (PANAS-C) questionary." Consisting of 34 items, with 17 items in each subscale, it is used to measure children's emotions during the previous weeks. The subscales measure positive and negative affect. The scale features words that describe different feelings and emotions on a 5-item Likert scale, ranging from 1 ("very little or not at all") to 5 ("extremely").

    1 year

  • Change in Empathy and Compassion

    Students will respond to the "Empathy and Compassion Scale" Consisting of 14 items, it assesses empathy and the ability to take perspective. It assesses how the individual relates to the difficulties faced by other people. It features a 5-item Likert scale ranging from "not at all like me" to "exactly how I

    1 year

  • Change in emotional expression scores

    They will answer the "Emotional Expression Scale in Children" It presents 6 questions about the child's ability to express their emotions. Each question is answered on a 5-item Likert scale ranging from "not at all true" to "completely true".

    1 year

  • Change in Self-compassion sco4es

    They will answer the Self-Compassion Scale - short version It has 12 questions about how the individual treats himself compared to the way he treats other people. Each question is answered on a 5-item Likert scale ranging from "never" to "always".

    1 year

  • Change in satisfaction with life perception scores

    They will answer the Life Satisfaction Scale for Children It has 5 questions about how satisfied the child is with his life. The Likert scale has 5 items ranging from "totally disagree" to "totally agree"

    1 year

  • Change in sense of comunity in the classroom scores

    They will answer the Scale of Sense of Community in the Classroom The scale has 14 items that assess students' perception in the classroom as belonging to a community and promoting group values. The 5-item Likert scale ranges from "strongly disagree" to "strongly agree" .

    1 year

  • Change in Academic Objectives scores

    They will answer the Academic Objectives Scale Scale of 6 items in which the student states about his perception of achieving learning objectives. 5-point Likert scale ranges from "not at all like me" to "exactly like me".

    1 year

  • the effects of TACM on students' ability to regulate their emotions by assessing their brain activity and cardiac variability

    Groups of children who were submitted to TACM will be avaluated in their emotional regulation capacities and have their brain activities and cardiac variability measured by Fnears and Polar before in 2 moments (before the training just before the end of the first semester and near the end of the school year, when they have already received all the training TACM)

    1 year

  • the effects of TACM on students' ability to regulate their emotions by assessing their brain activity

    Groups of children who were submitted to TACM will be avaluated in their emotional regulation capacities and have their brain activities measured by FNIRS (functional near infrared spectroscopy) in 2 moments (before the training just before the end of the first semester and near the end of the school year, when they have already received all the training TACM)

    1 year

  • Change in School performance

    Classification of colleagues according to social characteristics: In this report, students will make lists of colleagues who have the following characteristics: students who are generous; who show compassion; who get along well with others; get along well with their teachers.

    1 year

  • the effects of TACM on students' ability to regulate their emotions by assessing their heart rate variability the effects of TACM on student's ability to regulate their emotions by assessing the heart rate variability

    We will measure the heart rate variability using a Polar belt

    1 year

Secondary Outcomes (1)

  • Teachers TACM Literacy and aplication

    1 year

Study Arms (2)

First group to receive the intervention

EXPERIMENTAL

This cluster of classes of different scholls will be instructed in the social emotional and ethical learning training (SEELearning) and being tested trought questionaries.

Behavioral: SEELearning Training

Second group to receive the intervention

EXPERIMENTAL

The cluster of classes of different scholls forming the second group, will not be instructed in the social emotional and ethical learning training (SEELearning) in the first semester, but will answer the questionaries during this period. Than, in next semester they will receive the Training.

Behavioral: Waiting list group of the intervention

Interventions

This group will receive the Learning Training for Hearts and Minds and will be submitted to assessments and questionnaires that measure the improvement of well-being, reduction of stress and literacy in the contents and human values taught in the training. The program aims to increase participants' awareness, compassion and engagement. Compassion refers to cultivating a way of relating to oneself, others and humanity through kindness, empathy and genuine care for the happiness and suffering of these individuals. Awareness refers to cultivating a detailed, first-person understanding of thoughts, feelings, and emotions.

First group to receive the intervention

The group will remain on a waiting list and will respond to questionnaires about well-being and other items before receiving the training and, in the second semester, during the period in which it will receive the training

Second group to receive the intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students of selected public schools of Junidaí of the 4th and 5th grade of Brazilian elementary School

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

MeSH Terms

Conditions

Emotional RegulationAltruism

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Elementary school students from public schools (N = 600) will be invited to participate in the Learning for Hearts and Minds Training. Inclusion criteria: being students of the 4th and 5th years of elementary school I. Exclusion criteria: not having both terms signed (free and informed consent by those responsible and assent by the students). The student is undergoing neurological or psychiatric treatment (in this case, students will be invited to participate in the training, but will not be included in the study sample). The teacher responsible for the classroom is undergoing neurological or psychiatric treatment, or has a condition that prevents him from applying the TACM. The teacher in charge did not sign the free and informed consent form for their participation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

December 18, 2023

Study Start

January 10, 2023

Primary Completion

December 17, 2024

Study Completion

December 20, 2024

Last Updated

February 20, 2024

Record last verified: 2023-02

Locations