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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Mindfulness, Compassion, Self-Compassion, Academic Performance, School Climate, Mental Health
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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
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
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)
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
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.
- First posted15 Jul 2025
- Study start6 Oct 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Teresa Navarro Gil, Universidad de Zaragoza
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07066696
- Acronym / sponsor ID
- Cuida2 / PI24/587
- Conditions
- Mindfulness, Compassion, Self-Compassion, Academic Performance, School Climate, Mental Health
- Keywords
- Mindfulness, Compassion, Self-compassion, Primary School Students, Emotional and Behavioural Problems, School Climate, Academic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuida2 | Experimental | Behavioral: Mindfulness and Compassion ProgramThe "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. |
| Relaxation | Active comparator | Behavioral: Mindfulness and Compassion Program, Behavioral: RelaxationThe 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participant's decision to withdraw from the study at any point
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Compassion ProgramAlso: Cuida2The "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. | Behavioural | Cuida2, Relaxation |
| RelaxationThe 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. | Behavioural | Relaxation |
Primary outcome
Child and Adolescent Assessment System (Acronym in Spanish: SENA)
Time frame: From baseline to 3-month follow-up
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.
Compassion Scale for Children (CSC)
Time frame: From baseline to 3-month follow-up
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.
Academic performance
Time frame: From baseline to 3-month follow-up
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.
2 secondary outcomes
Qualitative assessment for students
Time frame: 9 weeks
Semi-structured global impression interview for teachers
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.