Clinical trial Recruiting at 3 sites Interventional Ages 8 to 13

Classroom mindfulness, compassion, and social-emotional programs for children in grades 3–7.

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

Run by IRCCS Fondazione Stella Maris · NCT07398781 · Data updated 2026-11-12

This project will try classroom mindfulness, compassion, and social-emotional activities to help children in grades 3–7 improve attention, emotion regulation, and thinking skills.

Quick facts

Study typeInterventional
Ages8 Years to 13 Years
SexAll
Enrollment500 (estimated)
SponsorIRCCS Fondazione Stella Maris
Academic / other
Locations4 sites (Florence, Firenze and 3 other locations)
StatusRecruiting
StartedApril 13, 2026
Main results expectedJune 2026
Study endsDecember 2027
Registry record updatedMarch 19, 2026
Trial IDNCT07398781 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are primary school students in grades 3–7 who attend participating schools in Pisa or Florence and have signed parental consent.

Probably not a fit

Children outside grades 3–7, those without parental consent, or students who require specialized clinical interventions are unlikely to benefit from these universal classroom programs.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children in grades 3–7 in participating schools receive one of three classroom programs: a mindfulness-based program, a compassion-focused training, or a social-emotional learning (SEL) program. Interventions are delivered through structured experiential activities by trained facilitators during regular class time. Participants complete standardized cognitive tests and questionnaires before and after the program that measure attention, executive function, emotion regulation, mindfulness, self-compassion, and social-emotional skills. The work is conducted by IRCCS Fondazione Stella Maris in collaboration with the Universities of Pisa and Florence and includes schools in Pisa and Florence, Italy.

Why it matters

Potential benefit: If successful, these programs could improve children's attention, emotional regulation, and social skills, supporting better learning and mental well-being.

How similar studies have gone: Prior school-based mindfulness and social-emotional learning programs have shown modest improvements in attention, behavior, and well-being, while direct comparisons including compassion-focused training in schools are more limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* Lack of signed consent

Where it's running

  • Università degli Studi di Firenze, Dipartimento di Scienze della Formazione e Psicologia
    Florence, Firenze, Italy
    Recruiting
  • Università di Pisa
    Pisa, Pisa, Italy
    Recruiting
  • IRCCS Fondazione Stella Maris
    Pisa, Pisa, Italy
    Recruiting
  • John Cabot University
    Roma, Roma, Italy
    Active not recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.