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Recruiting NCT07398781

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

No phase Interventional School-based Intervention Mindfulness-based Intervention Compassion Emotion Regulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-based intervention, Social Emotional Learning Program, Compassion-focused Training.
Who it may be relevant to
Registry conditions: School-based Intervention, Mindfulness-based Intervention, Compassion, Emotion Regulation. Basic parameters: 8 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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, observi
  • 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 every
  • 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 compassionat

Primary outcome measures

  • Mindfulness [Time frame: 10 days before intervention and 10 days after intervention]
  • Self-Compassion [Time frame: 10 days before intervention and 10 days after intervention]
  • Self-Esteem [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions - Visual Attention (NEPSY-II) [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions - Working Memory (WISC-IV) [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions - Inhibition Accuracy (TeleFE) [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions - Inhibition Speed (TeleFE) [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions - Interference control Accuracy (TeleFE) [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions - Interference control Speed (TeleFE) [Time frame: 10 days before intervention and 10 days after intervention]
  • Executive functions in daily life (QUFE) [Time frame: 10 days before intervention and 10 days after intervention]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Lack of signed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Italy · 4 centers
  • Università degli Studi di Firenze, Dipartimento di Scienze della Formazione e Psicologia — Florence
  • Università di Pisa — Pisa
  • IRCCS Fondazione Stella Maris — Pisa
  • John Cabot University — Roma

Identifiers

NCT: NCT07398781 · PACE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗