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

NCT07398781 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-03-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mindfulness-based intervention

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.

BEHAVIORAL

Social Emotional Learning Program

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.

BEHAVIORAL

Compassion-focused Training

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.

Sponsors & Collaborators

  • University of Pisa

    collaborator OTHER
  • University of Florence

    collaborator OTHER
  • John Cabot University

    collaborator UNKNOWN
  • IRCCS Fondazione Stella Maris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-06-30
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398781 on ClinicalTrials.gov