Social SkillsNCT06515444
Experimental Evaluation of a Program to Foster Socioemotional Competence of Children in Third Grade and Their Teachers
A study testing 10 minutes program and 1 hour PD program in people with Social Skills and Emotion Regulation, run by Universidad de los Andes, Chile at 3 sites in Chile.
Trial summary
The 10-minutes project is an experimental study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes. The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Social Skills, Emotion Regulation
- What is being tested?
- 10 minutes program and 1 hour PD program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 869 participants
- Where
- 3 sitesChile
- Study dates
- 22 Jul 2024to 1 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- . The inclusion criteria for schools: at least one third and one fourth grade class.
Who cannot join
- The exclusion criteria for schools are as follows: schools implementing a similar intervention in grades 3 and 4, and special needs schools.
Trial locations and contacts
3 sites in 1 country.
Chile3 sites
Schools
Curicó, Maule Region
Schools
Molina, Maule Region
Schools
Romeral, Maule Region
About this study
Official title: 10-minutes Project: Experimental Evaluation of the 10-minute Program to Foster Socioemotional Competence of Children in Third Grade and Their Teachers
The 10-minutes project is an experimental study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes.
The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation.
Read more
The 10-minute project is a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban/rural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as "delayed program" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years.
It is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.
Read the detailed description
Over the last 20 years the science of learning and economics of education has uplifted the relevance of socioemotional competence both for learning and other societal outcomes. Findings from neurobiology have illuminated how environmental factors such as poverty, exposure to stress or experiencing trauma, affect children's development of brain systems that support neurocognitive functions such as language, memory and self-regulation and therefore affecting their behavior, lifelong learning, and health (Immordino-Yang \& Damasio, 2007; Twardosz \& Lutzker, 2010; Noble, 2014; Chapko, 2015; Kolb \& Gibb, 2015; Thomason \& Marusak, 2017). Findings from the economics of education consistently indicates positive relationships between noncognitive skills and societal outcomes such as educational attainment (Farrington et al., 2012; Levin, 2012; Garcia, 2015), labor productivity and adult earnings (Casner-Lotto \& Barrington, 2006; Heckman, Stixrud \& Urzua, 2006; Murnane et al., 2001), and civic participation (Almlund, Duckworth, Heckman \& Kautz, 2011). This has led educators to pursue new strategies to support the social and emotional competence of children as well as their academic learning. Socioemotional learning (SEL hereafter) is the process through which individuals acquire socioemotional competence, the "process through which all young people and adults acquire and apply the knowledge, skills, and attitudes to develop healthy identities, manage emotions and achieve personal and collective goals, feel and show empathy for others, establish and maintain supportive relationships, and make responsible and caring decisions" (Niemi, 2020).
The 10-minutes project is a pilot study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes.
The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation. Each activity is presented along with knowledge for teachers on how to develop socioemotional skills in children. The curriculum is complemented by professional development for teachers on the development of their own socioemotional competencies.
The 10-minute project is a pilot study, primarily exploratory. It will provide data on the feasibility of the program, and its acceptability. The 10-minute project also has a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban/rural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as "delayed program" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years. Surveys will be used to collect data on student, classroom, and teacher outcomes in the 30 schools in fall 2024 (baseline), spring 2024 (first follow-up), and among fourth grade students in the same schools in spring 2025 (final follow-up). The intervention will take place after the baseline data is collected in March and April 2024.
It is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.
Why this program and study matters? This program and study are relevant for two main reasons: First, children and adults are facing a mental health crisis in Chile and elsewhere (Humphreys \& Irarrazaval, 2022; World Health Organization, 2022), and SEL programs have proven to be an effective way to increase children and adults' socioemotional competence (Durlak et al., in press), fundamental skills to cope with environmental stressors and daily challenges. Second, Chilean teachers have received little to no training in pre-service education (Milici \& Alcalay, 2020) and admit not having the necessary tools to tackle SEL in schools (Berger et al., 2009). This project presents an intervention that helps tackle both challenges and present a robust study design to argue for the causal impact of the intervention on children's and teachers' socioemotional competencies.
- Conditions
- Social Skills, Emotion Regulation
- Being tested
- 10 minutes program, 1 hour PD program
- Medical subject headings
- Social Skills, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 minutes programBehavioural
The curriculum component offers 10-minute daily doses of activities targeting the development of eight socioemotional competences in children: (i) emotional knowledge and management, (ii) developing a healthy identity, (iii) establishing and maintaining positive relationships, (iv) feeling and showing empathy, (v) establishing and reaching goals, (vi) responsible decision-making, (vii) contributing to the community and (viii) developing spirituality. The activities do not require the teacher to plan or to prepare material for the students.
1 hour PD programBehavioural
The professional development (PD) component is a 1-hour dose of activities targeting each of the eight SECs on which the curriculum focuses. The focus of PD is not to teach about SEC development in children but to develop SEC in teachers. Thus, this is an 8-hour PD program distributed throughout the academic year.
| Study group | Role | What they receive |
|---|---|---|
| 10 minutes only | Experimental | Group will only receive a socioemotional development material for teachers to implement with their students Receives: Behavioral: 10 minutes program |
| 10 minutes plus | Experimental | Group will receive socioemotioanl devleopment material for teachers to implement with their students plus professional development for teachers Receives: Behavioral: 10 minutes program; Behavioral: 1 hour PD program |
| Delayed | Other | While intervention in arms 1 and 2, this arm will not receive internvention. It will receive the 10 minutes plus, once the other two arms have their second year follow up measure. Receives: Behavioral: 10 minutes program; Behavioral: 1 hour PD program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Behavioral difficulties
will be assessed using the 20-item parental or teacher survey Strengths and Difficulties Questionnaire (SDQ) developed by Goodman (1997). The version for children was validated in Chile by Gaete et al. (2018) with internal consistency fluctuating between .76 and .85.
Measured: Months 1, 9 and 21
Teacher socioemotional competency
At the teacher level, the study assess the impact of the intervention on teachers socioemotioanl competency as measured by the Socioemotional Competence Inventory. This inventory was developed by Mikulic and colleagues (2015; reliability=0.89). This is a 72-item inventory that assesses self-efficacy, optimism, emotional regulation, assertiveness, emotional expression, emotional awareness, empathy, prosociality, and autonomy.
Measured: Months 1, 9, 21
Secondary outcomes (5)
Learning characteristics, leadership, motivation, communication, and planning skills.
The Scales for Rating the Behavioral Characteristics of Superior Students developed by Renzulli et al. (2002) will be used. This scale has 14 subscales. Only 5 will be used: leadership, learning characteristics, motivation, communication, and planning skills. The other scales refer to learning behavior in specific disciplines (such as arts, music, science, etc.) and that is why they will not be used. The items of these scales will be responded by parents.
Measured: Months 1, 9 and 21
Self-control
will be assessed using the Impulsivity Scale for Children (ISC). This is an 8-item survey responded by children that assesses the inability to regulate behavior, attention, and emotions in specific goals (Tsukayama, Duckworth \& Kim, 2013).
Measured: Months 1, 9 and 21
Pro-social attitude
will be assessed using the 18-item Empathy Questionnaire for Children and Adolescents (EmQue-CA) developed by Overgaauw, and colleagues (2017).
Measured: Months 1, 9 and 21
Mindset
Whether children view intelligence as a fixed trait rather than a trait that can be improved will be assessed using a 3-item scale developed by Dweck, Chiu and Hong (1995), widely used in Chile with an internal consistency of 0.86 (Claro, Paunesku \& Dweck, 2016).
Measured: Months 1, 9 and 21
Grit
The 10-item likert scale that measures perseverance, the Oviedo Grit Scale (OGS; Postigo, Cuesta, García-Cueto et al., 2021) will be used. The scale has been adapted to Chile (reliability = 0.92; Postigo, Barria, Cuesta, Garcia-Cueto, 2023).
Measured: Months 1, 9 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Jul 2024
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social SkillsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, Barbara Hanisch Cerda, Universidad de los Andes, Chile
- Investigators
- Barbara Hanisch-Cerda, PhD, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515444
- Sponsor's protocol ID
- CEC2024029
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanisch-Cerda B, Benitez-Yavar D. Enhancing socioemotional competencies: protocol for a three-arm cluster randomized controlled trial of a daily program for third graders and educators. Trials. 2025 Dec 24;26(1):580. doi: 10.1186/s13063-025-09183-0.
PubMed 41444899
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10-minutes Project: Experimental Evaluation of the 10-minute Program to Foster Socioemotional Competence of Children in Third Grade and Their Teachers
- ClinicalTrials.gov ID
- NCT06515444
- Acronym / sponsor ID
- CEC2024029
- Conditions
- Social Skills, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 23 Jul 2024 (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.
The 10-minutes project is an experimental study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes.
The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation.
The 10-minute project is a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban/rural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as "delayed program" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years.
It is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.
Detailed description
Over the last 20 years the science of learning and economics of education has uplifted the relevance of socioemotional competence both for learning and other societal outcomes. Findings from neurobiology have illuminated how environmental factors such as poverty, exposure to stress or experiencing trauma, affect children's development of brain systems that support neurocognitive functions such as language, memory and self-regulation and therefore affecting their behavior, lifelong learning, and health (Immordino-Yang \& Damasio, 2007; Twardosz \& Lutzker, 2010; Noble, 2014; Chapko, 2015; Kolb \& Gibb, 2015; Thomason \& Marusak, 2017). Findings from the economics of education consistently indicates positive relationships between noncognitive skills and societal outcomes such as educational attainment (Farrington et al., 2012; Levin, 2012; Garcia, 2015), labor productivity and adult earnings (Casner-Lotto \& Barrington, 2006; Heckman, Stixrud \& Urzua, 2006; Murnane et al., 2001), and civic participation (Almlund, Duckworth, Heckman \& Kautz, 2011). This has led educators to pursue new strategies to support the social and emotional competence of children as well as their academic learning. Socioemotional learning (SEL hereafter) is the process through which individuals acquire socioemotional competence, the "process through which all young people and adults acquire and apply the knowledge, skills, and attitudes to develop healthy identities, manage emotions and achieve personal and collective goals, feel and show empathy for others, establish and maintain supportive relationships, and make responsible and caring decisions" (Niemi, 2020).
The 10-minutes project is a pilot study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes.
The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation. Each activity is presented along with knowledge for teachers on how to develop socioemotional skills in children. The curriculum is complemented by professional development for teachers on the development of their own socioemotional competencies.
The 10-minute project is a pilot study, primarily exploratory. It will provide data on the feasibility of the program, and its acceptability. The 10-minute project also has a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban/rural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as "delayed program" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years. Surveys will be used to collect data on student, classroom, and teacher outcomes in the 30 schools in fall 2024 (baseline), spring 2024 (first follow-up), and among fourth grade students in the same schools in spring 2025 (final follow-up). The intervention will take place after the baseline data is collected in March and April 2024.
It is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.
Why this program and study matters? This program and study are relevant for two main reasons: First, children and adults are facing a mental health crisis in Chile and elsewhere (Humphreys \& Irarrazaval, 2022; World Health Organization, 2022), and SEL programs have proven to be an effective way to increase children and adults' socioemotional competence (Durlak et al., in press), fundamental skills to cope with environmental stressors and daily challenges. Second, Chilean teachers have received little to no training in pre-service education (Milici \& Alcalay, 2020) and admit not having the necessary tools to tackle SEL in schools (Berger et al., 2009). This project presents an intervention that helps tackle both challenges and present a robust study design to argue for the causal impact of the intervention on children's and teachers' socioemotional competencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 minutes only | Experimental | Behavioral: 10 minutes programGroup will only receive a socioemotional development material for teachers to implement with their students |
| 10 minutes plus | Experimental | Behavioral: 10 minutes program, Behavioral: 1 hour PD programGroup will receive socioemotioanl devleopment material for teachers to implement with their students plus professional development for teachers |
| Delayed | Other | Behavioral: 10 minutes program, Behavioral: 1 hour PD programWhile intervention in arms 1 and 2, this arm will not receive internvention. It will receive the 10 minutes plus, once the other two arms have their second year follow up measure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- . The inclusion criteria for schools: at least one third and one fourth grade class.
Key exclusion criteria (1 listed)
- The exclusion criteria for schools are as follows: schools implementing a similar intervention in grades 3 and 4, and special needs schools.
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 |
|---|---|---|
| 10 minutes programThe curriculum component offers 10-minute daily doses of activities targeting the development of eight socioemotional competences in children: (i) emotional knowledge and management, (ii) developing a healthy identity, (iii) establishing and maintaining positive relationships, (iv) feeling and showing empathy, (v) establishing and reaching goals, (vi) responsible decision-making, (vii) contributing to the community and (viii) developing spirituality. The activities do not require the teacher to plan or to prepare material for the students. | Behavioural | 10 minutes only, 10 minutes plus, Delayed |
| 1 hour PD programThe professional development (PD) component is a 1-hour dose of activities targeting each of the eight SECs on which the curriculum focuses. The focus of PD is not to teach about SEC development in children but to develop SEC in teachers. Thus, this is an 8-hour PD program distributed throughout the academic year. | Behavioural | 10 minutes plus, Delayed |
Primary outcome
Student Behavioral difficulties
Time frame: Months 1, 9 and 21
will be assessed using the 20-item parental or teacher survey Strengths and Difficulties Questionnaire (SDQ) developed by Goodman (1997). The version for children was validated in Chile by Gaete et al. (2018) with internal consistency fluctuating between .76 and .85.
Teacher socioemotional competency
Time frame: Months 1, 9, 21
At the teacher level, the study assess the impact of the intervention on teachers socioemotioanl competency as measured by the Socioemotional Competence Inventory. This inventory was developed by Mikulic and colleagues (2015; reliability=0.89). This is a 72-item inventory that assesses self-efficacy, optimism, emotional regulation, assertiveness, emotional expression, emotional awareness, empathy, prosociality, and autonomy.
5 secondary outcomes
Learning characteristics, leadership, motivation, communication, and planning skills.
Time frame: Months 1, 9 and 21
Self-control
Time frame: Months 1, 9 and 21
Pro-social attitude
Time frame: Months 1, 9 and 21
Mindset
Time frame: Months 1, 9 and 21
Grit
Time frame: Months 1, 9 and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 41444899Hanisch-Cerda B, Benitez-Yavar D. Enhancing socioemotional competencies: protocol for a three-arm cluster randomized controlled trial of a daily program for third graders and educators. Trials. 2025 Dec 24;26(1):580. doi: 10.1186/s13063-025-09183-0.
- Individual participant dataSharing planned: No
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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.
Barbara Hanisch-Cerda, PhD principal investigator
Universidad de los Andes, Chile
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 minutes program and 1 hour PD program in people with Social Skills and Emotion Regulation, run by Universidad de los Andes, Chile at 3 sites in Chile.
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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Student Behavioral difficulties (time frame: Months 1, 9 and 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515444, which also lists 1 linked publication.
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 4 Nov 2026.