PACE Study: School-Based Mindfulness and Compassion Interventions for Children

NCT07398781 | Recruiting

• 1 other identifier: PACE
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

School-based Intervention; Mindfulness-based Intervention; Compassion; Emotion Regulation

Keywords

mindfulness; compassion; emotion regulation; School

Outcome Measures

Primary Outcomes (14)

• 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).

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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).

  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

  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.

  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.

  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.

  10 days before intervention and 10 days after intervention

Study Arms (3)

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.

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.

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.

Behavioral: Compassion-focused Training

Interventions

Mindfulness-based intervention BEHAVIORAL

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.

Mindfulness Group

Social Emotional Learning Program BEHAVIORAL

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.

Social Emotional Learning Group

Compassion-focused Training BEHAVIORAL

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.

Compassion Group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be primary school students (grades 3rd-7th)

You may not qualify if:

• Lack of signed consent

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• University of Pisa: collaborator
• University of Florence: collaborator
• John Cabot University: collaborator

Study Sites (4)

Università degli Studi di Firenze, Dipartimento di Scienze della Formazione e Psicologia

Florence, Firenze, Italy

RECRUITING

Università di Pisa

Pisa, Pisa, 56126, Italy

RECRUITING

IRCCS Fondazione Stella Maris

Pisa, Pisa, 56128, Italy

RECRUITING

John Cabot University

Roma, Roma, 00165, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 10, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

IT (4)