AzTrials
AzTrials

MindfulnessCuida2NCT07066696

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.

A study testing Mindfulness and Compassion Program and Relaxation in people with Mindfulness and Compassion, run by Universidad de Zaragoza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Mindfulness, Compassion, Self-Compassion
What is being tested?
Mindfulness and Compassion Program and Relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
1 siteSpain
Study dates
6 Oct 2025to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Department of Psychology and Sociology. Faculty of Education. University of Zaragoza

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: 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 (Cuida2 Project)

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.

Read the detailed description

In recent years, special interest has been given to the social and emotional development of students due to the high prevalence of mental health problems, low academic motivation, school dropout, bullying and school aggression during late childhood and early adolescence. During this stage, students experience the transition from childhood to adolescence, which entails important biological, neurodevelopmental, social and psychological changes that can be difficult to cope with. The scientific literature indicates that there is a high prevalence of mental health disorders that affect the quality of life in childhood and that, if not adequately treated, can be maintained and aggravated during the adolescent years. On the other hand, data on school coexistence is relevant given the great impact it has on students' academic learning and personal development. As a result, problems related to understanding, respect and care for oneself and others are becoming increasingly important in the school population.

In view of the above, it is important to implement prevention and early intervention strategies that promote the proper overall development of students in order to prevent the effects of behavioural and emotional alterations that could lead to mental and physical health problems during this period of life and provide them with sufficient tools to deal with the various situations that arise in both the academic and personal spheres.

A growing number of studies suggest that Mindfulness-Based Interventions (hereafter MBI) produce numerous benefits such as improved attention, concentration emotional intelligence, self-control and reduced or prevented symptoms of anxiety and depression.

In addition, different studies find that more self-compassionate people experience higher levels of happiness, life satisfaction, emotional intelligence, acceptance and less fear of failure, depression and stress. On an interpersonal level, they show greater social connectedness, more tolerance for the imperfections of others and a greater willingness to help those in need.

The study population is Aragonese learners aged 10-12 years in the 5th and 6th grades of primary school. The total sample size needed has been calculated assuming a moderate effect of the mindfulness and compassion programme versus the control group on the main variable "emotional and behavioural problems" in the post-treatment. With a 1:1 allocation ratio, a statistical power of 80%, a bilateral alpha of 0.05, and a standard effect size d = 0.40 when comparing the two arms, a total of 198 participants (99 per group) were obtained; assuming a 10% drop-out rate at follow-up, the total required sample size was set at approximately 220 participants (about 110 per group to be randomised through the Epidat programme). On the other hand, the participation of a parent or guardian of each pupil will be requested, for a total of 220 family members. Finally, the tutors of each class, around 8 teachers, will be involved.

Variables assessed included emotional and behavioural problems, compassion and academic performance. Assessments will be conducted before and after the intervention, and at a three months follow-up.

Socio-demographic characteristics will be described by means of mean, standard deviation, frequencies and percentages, according to their distribution. Comparisons will be made to verify that there are no differences at baseline, using the t-test and the chi-square test. An analysis of covariance (ANCOVA) will be performed for both the primary measure "Child and Adolescent Assessment System, SENA" and the secondary measures, "CSC and academic achievement" by intention to treat (ITT), on the outcome variables after the intervention and on the follow-up measure. The baseline scores of the corresponding dependent variable, and those socio-demographic factors that show significant differences between the two groups at the first measurement point, will be included as covariates. The effect size will be calculated using the partial eta squared value. Values ≤ 0.01 correspond to a low effect size, = 0.06 to a medium effect size and ≥ 0.14 to a large effect size. Contrasts will be made between the pre-test and post-test measures for each group separately, using the corresponding t-test. The level of significance adopted will be α < 0.05.

To analyse the qualitative data "semi-structured global impression interview" two researchers will independently conduct thematic content analysis on the textual corpus following the constant comparison method (Glaser and Strauss, 1967), and developing an initial list of codes. Discrepancies between codings will be resolved by discussion, adjusting the initial list of codes until a common conceptual name is used. Similar codes will be grouped into a single underlying theme in order to represent a more parsimonious solution, allowing the emerging conceptual structure to gain in density. This latter categorisation will be specifically reviewed for discrepancies, resolving possible disagreements and resulting in a final update of the list of themes.

Being tested
Mindfulness and Compassion Program, Relaxation
Keywords
Mindfulness, Compassion, Self-compassion, Primary School Students, Emotional and Behavioural Problems, School Climate, Academic Performance
Medical subject headings
Psychological Well-Being, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness and Compassion ProgramBehavioural

    Also called Cuida2

    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.

  • RelaxationBehavioural

    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.

Study groups in NCT07066696
Study groupRoleWhat they receive
Cuida2ExperimentalThe "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.
Receives: Behavioral: Mindfulness and Compassion Program
RelaxationActive comparatorThe 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.
Receives: Behavioral: Mindfulness and Compassion Program; Behavioral: Relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to 3-month follow-up

  2. 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.

    Measured: From baseline to 3-month follow-up

  3. 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.

    Measured: From baseline to 3-month follow-up

Secondary outcomes (2)
  1. Qualitative assessment for students

    Students will answer a short 7-question survey in open-ended format and Likert-type scale that covers aspects such as perceived usefulness, putting into practice what they have learned, benefits and degree of satisfaction with the programme carried out.

    Measured: 9 weeks

  2. Semi-structured global impression interview for teachers

    At the end of the intervention, a semi-structured interview will be carried out with the tutor of each class, consisting of 9 questions in an open-ended format and Likert-type scale. This interview has been designed by Carlos García Rubio and collaborators (García-Rubio et al. 2019) and collects information on the subjective perception of the feasibility of the intervention, the beneficial and detrimental effects, the general impression and the potential of the intervention.

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start6 Oct 2025
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07066696
Sponsor's protocol ID
PI24/587
Acronym
Cuida2
Status last verified
Jul 2026
First submitted
18 Jun 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness and Compassion Program and Relaxation in people with Mindfulness and Compassion, run by Universidad de Zaragoza at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child and Adolescent Assessment System (Acronym in Spanish: SENA) (time frame: From baseline to 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in