Mindfulness and Compassion Program for the Improvement of Emotional and Behavioral Problems, Acad… (NCT07066696) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness and Compassion Program for the Improvement of Emotional and Behavioral Problems, Academic Performance and School Climate in Students in the Last Cycle of Primary Education.
Spain328 participantsStarted 2025-10-06
Plain-language summary
This randomized controlled trial aims to evaluate the efficacy of a Mindfulness and Compassion program to improve emotional and behavioral problems, academic performance and school climate of students in the last cycle of Primary Education.
Participants will be randomly assigned to the Cuida2 program or to an active control group practicing relaxation.
The different variables studied will be evaluated before and after the intervention, and at a three months follow-up. These evaluations will be carried out by the students and their families. In addition, a qualitative exploration will be carried out at the end of the programs, also including the teachers' perceptions.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* To be a pupil, parent/guardian of a child or minor under guardianship or academic tutor in the 5th or 6th year of Primary Education.
* Fluent in Spanish.
* Provided informed consent.
Exclusion Criteria:
* Participant's decision to withdraw from the study at any point
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Child and Adolescent Assessment System (Acronym in Spanish: SENA)