Health TrialsbyHealthPanel

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

ConditionsSchool-based InterventionMindfulness-based InterventionCompassionEmotion Regulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorIRCCS Fondazione Stella Maris

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Lack of signed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Mindfulness GroupExperimental treatment 1 intervention
Group B: Social Emotional Learning GroupActive comparator 1 intervention
Group C: Compassion GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
10 days before intervention and 10 days after intervention
2

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.

Time frame
10 days before intervention and 10 days after intervention
3

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).

Time frame
10 days before intervention and 10 days after intervention
4

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).

Time frame
10 days before intervention and 10 days after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Fondazione Stella Maris

Lead sponsor

University of Pisa

Collaborator

University of Florence

Collaborator

John Cabot University

Collaborator

Source ClinicalTrials.gov
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