Social Emotional LearningNCT06174467
Learning for Hearts and Minds in Elementary School
A study testing SEELearning Training and Waiting list group of the intervention in people with Social Emotional Learning, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Emotional Learning
- What is being tested?
- SEELearning Training and Waiting list group of the intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students of selected public schools of Junidaí of the 4th and 5th grade of Brazilian elementary School
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Social Emotional Learning
- Being tested
- SEELearning Training, Waiting list group of the intervention
- Keywords
- learning, social-emotional learning, emotion regulation, prosocial behavior
- Medical subject headings
- Emotional Regulation, Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEELearning TrainingBehavioural
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.
Waiting list group of the interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Waiting list group of the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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
Measured: 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".
Measured: 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".
Measured: 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"
Measured: 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" .
Measured: 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".
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 1 year
Secondary outcomes (1)
Teachers TACM Literacy and aplication
The teachers responsible for the classrooms will be trained in TACM during the semester and will be evaluated in terms of attendance at training, filling out questionnaires, participating in chats, self-assessing their levels of stress, frustration, well-being, motivation and attention in a scale (items ranging from 0 to 10).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start10 Jan 2023
- Primary completion17 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Emotional LearningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Gaia Mais, Universidade Federal do ABC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174467
- Sponsor's protocol ID
- ACM-Students-Intervention
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06174467
- Acronym / sponsor ID
- ACM-Students-Intervention
- Conditions
- Social Emotional Learning
- Keywords
- learning, social-emotional learning, emotion regulation, prosocial behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Emory University, Gaia Mais, Universidade Federal do ABC
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 17 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| First group to receive the intervention | Experimental | Behavioral: SEELearning TrainingThis cluster of classes of different scholls will be instructed in the social emotional and ethical learning training (SEELearning) and being tested trought questionaries. |
| Second group to receive the intervention | Experimental | Behavioral: Waiting list group of the interventionThe 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students of selected public schools of Junidaí of the 4th and 5th grade of Brazilian elementary School
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEELearning TrainingThis 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. | Behavioural | First group to receive the intervention |
| Waiting list group of the interventionThe 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 | Behavioural | Second group to receive the intervention |
Primary outcome
Change in Positive and negative Affects scores
Time frame: 1 year
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").
Change in Empathy and Compassion
Time frame: 1 year
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
Change in emotional expression scores
Time frame: 1 year
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".
Change in Self-compassion sco4es
Time frame: 1 year
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".
Change in satisfaction with life perception scores
Time frame: 1 year
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"
Change in sense of comunity in the classroom scores
Time frame: 1 year
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" .
Change in Academic Objectives scores
Time frame: 1 year
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".
the effects of TACM on students' ability to regulate their emotions by assessing their brain activity and cardiac variability
Time frame: 1 year
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)
the effects of TACM on students' ability to regulate their emotions by assessing their brain activity
Time frame: 1 year
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)
Change in School performance
Time frame: 1 year
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.
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
Time frame: 1 year
We will measure the heart rate variability using a Polar belt
1 secondary outcome
Teachers TACM Literacy and aplication
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEELearning Training and Waiting list group of the intervention in people with Social Emotional Learning, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and negative Affects scores (time frame: 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.