School-based InterventionPACENCT07398781
PACE Study: School-Based Mindfulness and Compassion Interventions for Children
A study testing Mindfulness-based intervention, Social Emotional Learning Program and Compassion-focused Training in people with School-based Intervention and Mindfulness-based Intervention, run by IRCCS Fondazione Stella Maris at 4 sites in Italy.
Trial summary
This study aims to evaluate the effects of three school-based interventions focused on mindfulness, compassion, and social-emotional learning on children's psychological well-being and higher-order cognitive functions. The interventions are delivered in the classroom through structured experiential activities. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- School-based Intervention, Mindfulness-based Intervention, Compassion
- What is being tested?
- Mindfulness-based intervention, Social Emotional Learning Program and Compassion-focused Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesItaly
- Study dates
- 13 Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must be primary school students (grades 3rd-7th)
Who cannot join
- Lack of signed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 3 recruiting
- Recruiting
Università degli Studi di Firenze, Dipartimento di Scienze della Formazione e Psicologia
Florence, Firenze
Chiara Pecini, +39 0552756101, chiara.pecini@unifi.it
Costanza Ruffini
- Recruiting
Università di Pisa
Pisa, Pisa, 56126
Ciro Conversano, +39 0502212111, ciro.conversano@unipi.it
- Recruiting
IRCCS Fondazione Stella Maris
Pisa, Pisa, 56128
Pietro Muratori, +39 050 886100, pietro.muratori@fsm.unipi.it
Carlotta Bertini
- Active, not recruiting
John Cabot University
Roma, Roma, 00165
About this study
Official title: The PACE Study (Present-Moment Awareness, Attention, Compassion, Emotion Regulation): Effects of School-Based Mindfulness and Compassion Interventions
This study aims to evaluate the effects of three school-based interventions focused on mindfulness, compassion, and social-emotional learning on children's psychological well-being and higher-order cognitive functions.
The interventions are delivered in the classroom through structured experiential activities. Children are assessed before and after the interventions using standardized tests and questionnaires measuring attention, executive functions, emotional regulation, mindfulness, self-compassion, and social-emotional skills.
- Being tested
- Mindfulness-based intervention, Social Emotional Learning Program, Compassion-focused Training
- Keywords
- mindfulness, compassion, emotion regulation, School
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
The mindfulness intervention is a six-session, school-based program that aims to promote emotional awareness, body awareness, attentional regulation, and basic self-regulation skills through age-appropriate metaphors, experiential activities, and brief mindfulness-based practices. Sessions include storytelling, movement games, sensory exploration, breathing exercises, and short grounding activities. Key topics include understanding body-emotion connections, recognizing bodily sensations, observing thoughts, and training attention through breathing and sensory awareness. At the end of each session, children reflect on what they learned through drawing or group discussion, and the main themes of the program are visually summarized in a classroom poster that tracks the progression of the five sessions.
Social Emotional Learning ProgramBehavioural
The SEL intervention consists of six classroom-based modules aimed at promoting emotional competence and social skills in primary school children. Modules address: (1) program presentation and personal goal setting; (2) recognition and understanding of basic emotions and their behavioral, cognitive, and physiological components; (3) emotional self-regulation strategies such as calming self-talk and positive distraction; (4) empathy and perspective-taking; (5) structured problem-solving for everyday conflicts; and (6) recognition of personal and peer strengths.
Compassion-focused TrainingBehavioural
The Compassion-focused Training consists of six classroom-based modules aimed at developing compassion, emotional awareness, and self-regulation in primary school children. Modules address: (1) introduction to compassion and its three flows (toward self, toward others, and receiving compassion); (2) understanding the "tricky brain" and the role of thoughts and emotions; (3) learning the three emotional systems (threat, drive, and soothing); (4) cultivating feelings of safety through compassionate imagery and sensory awareness; (5) exploring different parts of the self and developing the compassionate self; and (6) understanding and responding to self-criticism with compassion through reflective and creative activities.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Group | Experimental | Children in this arm will participate in a six-module school-based mindfulness intervention that aims to promote emotional awareness, body awareness, attentional regulation, and basic self-regulation skills through age-appropriate metaphors, experiential activities, and brief mindfulness-based practices. Receives: Behavioral: Mindfulness-based intervention |
| Social Emotional Learning Group | Active comparator | Children in this arm will participate in a six-module Social Emotional Learning (SEL) intervention. The program focuses on developing skills in emotion recognition, emotion regulation, perspective taking, problem solving, and social skills. Receives: Behavioral: Social Emotional Learning Program |
| Compassion Group | Experimental | Children in this arm will participate in a six-module Compassion-focused training, aimed at developing compassion, emotional awareness, and self-regulation in primary school children. Receives: Behavioral: Compassion-focused Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness
Students' mindfulness will be evaluated with the Child and Adolescent Mindfulness Measure (La Greco et al., 2011), a 10-item self-report measure. Items are rated on a 5-point Likert scale (0 = Never true, 4 = Always true). Higher scores indicate greater mindfulness (range 0-40).
Measured: 10 days before intervention and 10 days after intervention
Self-Compassion
Students' self-compassion will be assessed using the Self-Compassion Scale for Children (SCS-C; Sutton et al., 2018), a 12-item self-report measure. Items are rated on a 5-point Likert scale (1 = Almost never, 5 = Almost always). Higher scores indicate higher levels of self-compassion.
Measured: 10 days before intervention and 10 days after intervention
Self-Esteem
Students' self-esteem will be assessed using the Rosenberg Self-Esteem Scale (Rosenberg, 1965), a 10-item self-report measure. Likert scale (0 = Strongly Disagree, 3 = Strongly Agree). Higher scores indicate higher self-esteem (range 0-30).
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Visual Attention (NEPSY-II)
Visual attention is assessed using the Visual Attention subtest of NEPSY-II, measuring speed and accuracy of visual attention. Low scores suggest deficits in selective attention or processing speed. The completion time is 180 seconds and accuracy is measured as the difference between the target stimuli identified and the distractor stimuli. The score is converted into scalar scores (minimum: 1 - maximum 19).
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Working Memory (WISC-IV)
Working memory/sequencing ability is assessed using the Letter-Number Sequencing subtest of WISC-IV. Scoring involves giving points for correctly sequenced items, leading to a raw score, which is then converted into a standardized scaled score (from 1 to 19) for comparison, reflecting the child's ability in short-term auditory memory and mental flexibility.
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Inhibition Accuracy (TeleFE)
Response inhibition is assessed using the Go/No-Go task from the TeleFE battery. The child is presented with a target stimulus and a non-target stimulus sequentially on the screen and must press the spacebar as soon as possible when the target stimulus appears. The task consists of 4 blocks, each with 35 target stimuli and 15 non-target stimuli. Each block therefore, contains a total of 50 stimuli (35 Go and 15 No-Go). In the present study, only the geometric shapes version of the Go/No-Go task was administered. From this task, an index of inhibition accuracy, calculated as the number of correct responses to non-target stimuli and expressed in percentiles (minimum: 0; maximum: 100), is obtained.
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Inhibition Speed (TeleFE)
Response inhibition is assessed using the Go/No-Go task from the TeleFE battery. The child is presented with a target stimulus and a non-target stimulus sequentially on the screen and must press the spacebar as soon as possible when the target stimulus appears. The task consists of 4 blocks, each with 35 target stimuli and 15 non-target stimuli. Each block therefore, contains a total of 50 stimuli (35 Go and 15 No-Go). In the present study, only the geometric shapes version of the Go/No-Go task was administered. From this task, an index of inhibition speed, calculated as the time of correct responses to target stimuli and expressed in percentiles (minimum: 0; maximum: 100), is obtained.
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Interference control Accuracy (TeleFE)
Interference control is assessed using the the 1st and 2nd blocks of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, an accuracy index expressed in percentiles (minimum: 0; maximum: 100) from the correct responses of the first two blocks is obtained.
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Interference control Speed (TeleFE)
Interference control is assessed using the the 1st and 2nd blocks of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, a speed index expressed in percentiles (minimum: 0; maximum: 100) from the reaction time at the correct response of the first two blocks is obtained.
Measured: 10 days before intervention and 10 days after intervention
Executive functions in daily life (QUFE)
Executive function in daily life is assessed using the QUFE parent-report questionnaire, covering multiple aspects of executive functioning. Questionnaires for Executive Functions (QUFE; Schweiger \& Marzocchi, 2008) for parents are completed to assess child's executive functioning within life context, specifically the home. The questionnaire consisted of 32 items on a five-point Likert scale, concerning 5 areas of investigation (cognitive self-regulation, behavioral self-regulation, material management, flexibility of adaptation, and spirit of initiative) for parents. A Global score is calculated (maximum: 160; minimum score: 32).
Measured: 10 days before intervention and 10 days after intervention
Emotional Instability
Students' emotional instability is assessed using the parent-report Emotional Instability Scale (Pastorelli et al., 1997). This 20-item scale measures difficulties in emotion regulation and the tendency to experience negative affect. Answers are rated on a 3-point Likert scale (3 = Often, 2 = Sometimes, 1 = Never). Higher scores indicate higher emotional instability
Measured: 10 days before intervention and 10 days after intervention
Prosocial Behavior
Students' prosocial behavior is assessed using the parent-report Prosocial Behavior Scale (Pastorelli et al., 1997). This 15-item scale evaluates positive social behaviors. Answers are rated on a 3-point Likert scale (3 = Often, 2 = Sometimes, 1 = Never). Higher scores indicated higher levels of prosociality.
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Cognitive Flexibility Accuracy (TeleFE)
Cognitive flexibility is assessed using the the 3rd block of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, an accuracy index expressed in percentiles (minimum: 0; maximum: 100) from the correct responses of the third is obtained.
Measured: 10 days before intervention and 10 days after intervention
Executive functions - Cognitive Flexibility Speed (TeleFE)
Cognitive flexibility is assessed using the the 3rd block of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, a speed expressed in percentiles (minimum: 0; maximum: 100) from the reaction time of correct responses of the third block is obtained.
Measured: 10 days before intervention and 10 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start13 Apr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School-based InterventionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, University of Florence, John Cabot University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398781
- Sponsor's protocol ID
- PACE
- Acronym
- PACE
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2026
- Last updated
- 19 Mar 2026
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PACE Study (Present-Moment Awareness, Attention, Compassion, Emotion Regulation): Effects of School-Based Mindfulness and Compassion Interventions
- ClinicalTrials.gov ID
- NCT07398781
- Acronym / sponsor ID
- PACE / PACE
- Keywords
- mindfulness, compassion, emotion regulation, School
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- University of Pisa, University of Florence, John Cabot University
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Feb 2026 (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.
This study aims to evaluate the effects of three school-based interventions focused on mindfulness, compassion, and social-emotional learning on children's psychological well-being and higher-order cognitive functions.
The interventions are delivered in the classroom through structured experiential activities. Children are assessed before and after the interventions using standardized tests and questionnaires measuring attention, executive functions, emotional regulation, mindfulness, self-compassion, and social-emotional skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Behavioral: Mindfulness-based interventionChildren in this arm will participate in a six-module school-based mindfulness intervention that aims to promote emotional awareness, body awareness, attentional regulation, and basic self-regulation skills through age-appropriate metaphors, experiential activities, and brief mindfulness-based practices. |
| Social Emotional Learning Group | Active comparator | Behavioral: Social Emotional Learning ProgramChildren in this arm will participate in a six-module Social Emotional Learning (SEL) intervention. The program focuses on developing skills in emotion recognition, emotion regulation, perspective taking, problem solving, and social skills. |
| Compassion Group | Experimental | Behavioral: Compassion-focused TrainingChildren in this arm will participate in a six-module Compassion-focused training, aimed at developing compassion, emotional awareness, and self-regulation in primary school children. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants must be primary school students (grades 3rd-7th)
Key exclusion criteria (1 listed)
- Lack of signed consent
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 |
|---|---|---|
| Mindfulness-based interventionThe mindfulness intervention is a six-session, school-based program that aims to promote emotional awareness, body awareness, attentional regulation, and basic self-regulation skills through age-appropriate metaphors, experiential activities, and brief mindfulness-based practices. Sessions include storytelling, movement games, sensory exploration, breathing exercises, and short grounding activities. Key topics include understanding body-emotion connections, recognizing bodily sensations, observing thoughts, and training attention through breathing and sensory awareness. At the end of each session, children reflect on what they learned through drawing or group discussion, and the main themes of the program are visually summarized in a classroom poster that tracks the progression of the five sessions. | Behavioural | Mindfulness Group |
| Social Emotional Learning ProgramThe SEL intervention consists of six classroom-based modules aimed at promoting emotional competence and social skills in primary school children. Modules address: (1) program presentation and personal goal setting; (2) recognition and understanding of basic emotions and their behavioral, cognitive, and physiological components; (3) emotional self-regulation strategies such as calming self-talk and positive distraction; (4) empathy and perspective-taking; (5) structured problem-solving for everyday conflicts; and (6) recognition of personal and peer strengths. | Behavioural | Social Emotional Learning Group |
| Compassion-focused TrainingThe Compassion-focused Training consists of six classroom-based modules aimed at developing compassion, emotional awareness, and self-regulation in primary school children. Modules address: (1) introduction to compassion and its three flows (toward self, toward others, and receiving compassion); (2) understanding the "tricky brain" and the role of thoughts and emotions; (3) learning the three emotional systems (threat, drive, and soothing); (4) cultivating feelings of safety through compassionate imagery and sensory awareness; (5) exploring different parts of the self and developing the compassionate self; and (6) understanding and responding to self-criticism with compassion through reflective and creative activities. | Behavioural | Compassion Group |
Primary outcome
Mindfulness
Time frame: 10 days before intervention and 10 days after intervention
Students' mindfulness will be evaluated with the Child and Adolescent Mindfulness Measure (La Greco et al., 2011), a 10-item self-report measure. Items are rated on a 5-point Likert scale (0 = Never true, 4 = Always true). Higher scores indicate greater mindfulness (range 0-40).
Self-Compassion
Time frame: 10 days before intervention and 10 days after intervention
Students' self-compassion will be assessed using the Self-Compassion Scale for Children (SCS-C; Sutton et al., 2018), a 12-item self-report measure. Items are rated on a 5-point Likert scale (1 = Almost never, 5 = Almost always). Higher scores indicate higher levels of self-compassion.
Self-Esteem
Time frame: 10 days before intervention and 10 days after intervention
Students' self-esteem will be assessed using the Rosenberg Self-Esteem Scale (Rosenberg, 1965), a 10-item self-report measure. Likert scale (0 = Strongly Disagree, 3 = Strongly Agree). Higher scores indicate higher self-esteem (range 0-30).
Executive functions - Visual Attention (NEPSY-II)
Time frame: 10 days before intervention and 10 days after intervention
Visual attention is assessed using the Visual Attention subtest of NEPSY-II, measuring speed and accuracy of visual attention. Low scores suggest deficits in selective attention or processing speed. The completion time is 180 seconds and accuracy is measured as the difference between the target stimuli identified and the distractor stimuli. The score is converted into scalar scores (minimum: 1 - maximum 19).
Executive functions - Working Memory (WISC-IV)
Time frame: 10 days before intervention and 10 days after intervention
Working memory/sequencing ability is assessed using the Letter-Number Sequencing subtest of WISC-IV. Scoring involves giving points for correctly sequenced items, leading to a raw score, which is then converted into a standardized scaled score (from 1 to 19) for comparison, reflecting the child's ability in short-term auditory memory and mental flexibility.
Executive functions - Inhibition Accuracy (TeleFE)
Time frame: 10 days before intervention and 10 days after intervention
Response inhibition is assessed using the Go/No-Go task from the TeleFE battery. The child is presented with a target stimulus and a non-target stimulus sequentially on the screen and must press the spacebar as soon as possible when the target stimulus appears. The task consists of 4 blocks, each with 35 target stimuli and 15 non-target stimuli. Each block therefore, contains a total of 50 stimuli (35 Go and 15 No-Go). In the present study, only the geometric shapes version of the Go/No-Go task was administered. From this task, an index of inhibition accuracy, calculated as the number of correct responses to non-target stimuli and expressed in percentiles (minimum: 0; maximum: 100), is obtained.
Executive functions - Inhibition Speed (TeleFE)
Time frame: 10 days before intervention and 10 days after intervention
Response inhibition is assessed using the Go/No-Go task from the TeleFE battery. The child is presented with a target stimulus and a non-target stimulus sequentially on the screen and must press the spacebar as soon as possible when the target stimulus appears. The task consists of 4 blocks, each with 35 target stimuli and 15 non-target stimuli. Each block therefore, contains a total of 50 stimuli (35 Go and 15 No-Go). In the present study, only the geometric shapes version of the Go/No-Go task was administered. From this task, an index of inhibition speed, calculated as the time of correct responses to target stimuli and expressed in percentiles (minimum: 0; maximum: 100), is obtained.
Executive functions - Interference control Accuracy (TeleFE)
Time frame: 10 days before intervention and 10 days after intervention
Interference control is assessed using the the 1st and 2nd blocks of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, an accuracy index expressed in percentiles (minimum: 0; maximum: 100) from the correct responses of the first two blocks is obtained.
Executive functions - Interference control Speed (TeleFE)
Time frame: 10 days before intervention and 10 days after intervention
Interference control is assessed using the the 1st and 2nd blocks of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, a speed index expressed in percentiles (minimum: 0; maximum: 100) from the reaction time at the correct response of the first two blocks is obtained.
Executive functions in daily life (QUFE)
Time frame: 10 days before intervention and 10 days after intervention
Executive function in daily life is assessed using the QUFE parent-report questionnaire, covering multiple aspects of executive functioning. Questionnaires for Executive Functions (QUFE; Schweiger \& Marzocchi, 2008) for parents are completed to assess child's executive functioning within life context, specifically the home. The questionnaire consisted of 32 items on a five-point Likert scale, concerning 5 areas of investigation (cognitive self-regulation, behavioral self-regulation, material management, flexibility of adaptation, and spirit of initiative) for parents. A Global score is calculated (maximum: 160; minimum score: 32).
Emotional Instability
Time frame: 10 days before intervention and 10 days after intervention
Students' emotional instability is assessed using the parent-report Emotional Instability Scale (Pastorelli et al., 1997). This 20-item scale measures difficulties in emotion regulation and the tendency to experience negative affect. Answers are rated on a 3-point Likert scale (3 = Often, 2 = Sometimes, 1 = Never). Higher scores indicate higher emotional instability
Prosocial Behavior
Time frame: 10 days before intervention and 10 days after intervention
Students' prosocial behavior is assessed using the parent-report Prosocial Behavior Scale (Pastorelli et al., 1997). This 15-item scale evaluates positive social behaviors. Answers are rated on a 3-point Likert scale (3 = Often, 2 = Sometimes, 1 = Never). Higher scores indicated higher levels of prosociality.
Executive functions - Cognitive Flexibility Accuracy (TeleFE)
Time frame: 10 days before intervention and 10 days after intervention
Cognitive flexibility is assessed using the the 3rd block of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, an accuracy index expressed in percentiles (minimum: 0; maximum: 100) from the correct responses of the third is obtained.
Executive functions - Cognitive Flexibility Speed (TeleFE)
Time frame: 10 days before intervention and 10 days after intervention
Cognitive flexibility is assessed using the the 3rd block of the Flanker task from the TeleFE battery. The child is presented with a series of five arrows aligned on the screen, which can point all to the right or to the left (congruent condition), as well as the arrow in the middle can have the opposite direction to those on the side (incongruent condition). This task requires the child to rapidly shift between response criteria and implement them accurately. In all trials, a fixation point is displayed on the screen for approximately 600-1200 ms before each set of arrows. From this task, a speed expressed in percentiles (minimum: 0; maximum: 100) from the reaction time of correct responses of the third block is obtained.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
Università degli Studi di Firenze, Dipartimento di Scienze della Formazione e Psicologia
Florence, Italy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention, Social Emotional Learning Program and Compassion-focused Training in people with School-based Intervention and Mindfulness-based Intervention, run by IRCCS Fondazione Stella Maris at 4 sites in Italy.
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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness (time frame: 10 days before intervention and 10 days after intervention). The study lists 14 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 19 Mar 2026.