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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversidad de Zaragoza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

448 Participants
are divided into 2 treatment groups
Group A: Cuida2Experimental treatment 1 intervention
Group B: RelaxationActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
From baseline to 3-month follow-up

Secondary outcomes

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.

Time frame
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.

Time frame
9 weeks

Other outcomes

1

Participant age

Age of participants, measured in years.

Time frame
At baseline
2

Course

Course attended by the student.

Time frame
At baseline
3

Gender

Participant's gender

Time frame
At baseline

Sponsors and contacts

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