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.

NCT07066696 | Not Yet Recruiting

• 1 other identifier: PI24/587
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mindfulness; Compassion; Self-Compassion; Academic Performance; School Climate; Mental Health; Primary School Students

Keywords

Mindfulness; Compassion; Self-compassion; Primary School Students; Emotional and Behavioural Problems; School Climate; Academic Performance

Outcome Measures

Primary Outcomes (3)

• Child and Adolescent Assessment System (Acronym in Spanish: SENA)

  It collects information on emotional and behavioural problems by means of a self-report questionnaire (8 to 12 years old) composed of 134 items where the participant has to choose one option on a five-point scale (Never or almost never to Always or almost always); examples: 'I am told that I interrupt others and that I don't let them talk', 'school is stupid'. The questionnaire evaluates four blocks of scales: I) scales of problems, composed of internalised problems (depression, anxiety, social anxiety and somatic complaints), externalised problems (attention problems, hyperactivity-impulsivity, anger control, aggression and defiant behaviour), II) contextual problems, family problems, problems with the school and with peers, III) scales of vulnerabilities, problems of emotional regulation and IV) scales of personal resources, self-esteem, integration and social competence.

  From baseline to 3-month follow-up

• Compassion Scale for Children (CSC)

  This questionnaire measures three factors related to compassion: compassion for other people, compassion for oneself and compassion for other living beings. The scale consists of 20 items whose responses employ a 5-point Likert format for responses, where 1 indicates "Never," 2 means "Rarely," 3 represents "Sometimes," 4 indicates "Often," and 5 signifies "Always". The minimum score is 20 points and the maximum is 100, with the higher the score indicating a higher level of compassion.

  From baseline to 3-month follow-up

• Academic performance

  Each student's academic performance will be assessed by comparing the average grade obtained in all subjects taught in the trimester before and after the intervention.

  From baseline to 3-month follow-up

Secondary Outcomes (2)

• Qualitative assessment for students

  9 weeks

• Semi-structured global impression interview for teachers

  9 weeks

Other Outcomes (3)

• Participant age

  At baseline

• Course

  At baseline

• Gender

  At baseline

Study Arms (2)

Cuida2

EXPERIMENTAL

The "CUIDA2" program is an adaptation of the manual "The practice of compassion. Kindness with others and with oneself" (2019) by Dr. Javier García Campayo. It comprises a total of 9 sessions of approximately 50 minutes (one class). This program is structured in 3 modules: Module I mindfulness, module II compassion and module III convergence of the previous elements. Each module includes group dynamics, short meditation practices adapted to the trainees and the explanation of the main theoretical contents through exercises and stories.

Behavioral: Mindfulness and Compassion Program

Relaxation

ACTIVE COMPARATOR

The active control group consists of a relaxation programme consisting of 9 sessions. The sessions will be given weekly (once a week) and have an estimated duration of 50 minutes. Different breathing practices and exercises and relaxation techniques such as visualisation, Jacobson's progressive relaxation and Schultz's autogenic relaxation will be worked on.

Behavioral: Mindfulness and Compassion Program; Behavioral: Relaxation

Interventions

Mindfulness and Compassion Program BEHAVIORAL

The "CUIDA2" program is an adaptation of the manual "The practice of compassion. Kindness with others and with oneself" (2019) by Dr. Javier García Campayo. It comprises a total of 9 sessions of approximately 50 minutes (one class). This program is structured in 3 modules: Module I mindfulness, module II compassion and module III convergence of the previous elements. Each module includes group dynamics, short meditation practices adapted to the trainees and the explanation of the main theoretical contents through exercises and stories.

Also known as: Cuida2

Cuida2; Relaxation

Relaxation BEHAVIORAL

The active control group is composed of a relaxation program consisting of 9 sessions. The sessions will be given weekly (once a week) and have an estimated duration of 50 minutes. Different breathing practices and exercises and relaxation techniques such as visualization, Jacobson's progressive relaxation and Schultz's autogenic relaxation will be used.

Relaxation

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant's decision to withdraw from the study at any point

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Department of Psychology and Sociology. Faculty of Education. University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Psychological Well-Being; Mental Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

María Teresa Navarro Gil

CONTACT

+34976506578; mnavarrogil@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 15, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)