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NCT Number: NCT07398781

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

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.

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Key information

Conditions

School-based Intervention Behavior Compassion Emotion Regulation Emotional Regulation Mindfulness-based Intervention Self-Control Social Behavior

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of signed consent

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Collaborators

  • John Cabot University
  • University of Florence
  • University of Pisa

Registry information

Official study title

The PACE Study (Present-Moment Awareness, Attention, Compassion, Emotion Regulation): Effects of School-Based Mindfulness and Compassion Interventions

Acronym: PACE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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