Clinical trial NCT06174467: Learning for Hearts and Minds in Elementary School
Official title: Learning for Hearts and Minds (ACM) in Elementary School Students From Public Schools: a Randomized Controlled Trial on Socio-emotional Skills and Brain Functioning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Emotional Learning
Keywords: learning
social-emotional learning
emotion regulation
prosocial behavior
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Emory University
name: Gaia Mais
name: Universidade Federal do ABC
First posted: 2023-12-18
Enrollment: 600
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Positive and negative Affects scores
timeFrame: 1 year
measure: Change in Empathy and Compassion
timeFrame: 1 year
measure: Change in emotional expression scores
timeFrame: 1 year
measure: Change in Self-compassion sco4es
timeFrame: 1 year
measure: Change in satisfaction with life perception scores
timeFrame: 1 year
measure: Change in sense of comunity in the classroom scores
timeFrame: 1 year
measure: Change in Academic Objectives scores
timeFrame: 1 year
measure: the effects of TACM on students' ability to regulate their emotions by assessing their brain activity and cardiac variability
timeFrame: 1 year
measure: the effects of TACM on students' ability to regulate their emotions by assessing their brain activity
timeFrame: 1 year
measure: Change in School performance
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Teachers TACM Literacy and aplication
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
References: