Mindfulness, Empathy and Social Integration. Its Relation With Chonic Stress
NCT ID: NCT04177017
Last Updated: 2019-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2017-03-20
2018-06-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.
NCT05516355
Health, Integration, Concentration: Mindfulness in Schools
NCT03141229
Mindfulness for Mothers of Children With Disabilities
NCT05620368
Efficacy and Implementation of MINDxYOU Program for Reducing Stress and Promote Mental Health Among Healthcare Providers
NCT05436717
The Impact of Mindfulness-Based Stress Reduction on Mindfulness, Self-Compassion, and Perceived Stress Among Healthcare Professionals
NCT07022613
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Informative talks will be given to parents of potential participants, teachers and managers of educational establishments, in order to inform about research objectives and methodology. The nature of voluntary participation in any of the activities and procedures, as well as the confidential treatment of the information will be duly clarified. Informed consent will be requested from parents if they agree to participate in the project.
The intervention program will consist of a weekly meeting of approximately 1 hour during the school year, and will be conducted by the researchers together with the teacher in charge of the group. This program will include practices that promote self-perception, interoception and collaborative activities, followed by an instance of group reflection that promotes perspective taking (as in Lozada et al 2017).
The practices of self-perception and interoception consist, for example, in focusing attention on breathing for a period of time that will gradually increase (mindfulness). During collaborative actions, children will carry out activities in dyads or in small groups that promote empathy and pro-social behavior. The last activity of the intervention will consist of an instance of group reflection in which experiences and perceptions of the participants will be shared in order to favor perspective taking (i.e. the cognitive ability to consider the world from the point of view of the other).
The variables (pro-social behavior and hair cortisol levels) are quantified at the beginning and at the end of each intervention (ie, pre and post-test evaluation). To assess the differences in each group, pre-post levels will be compared by means of the paired t test, and comparisons between the experimental and control groups will be made by means of variance analysis tests and Mann Withney tests and Kruskal Wallis.
Children participating in the experimental and control groups will be individually evaluated using the following methods:
3\) Sociometric questionnaire.
Stress levels are quantified through:
1\) Hair cortisol dosing. This parameter is an indicator of chronic stress whose advantage is that it does not show marked variability throughout the day such as salivary cortisol. For this, it is necessary to cut a small strand of hair that will be analyzed later by Pharmacy and Biochemistry researchers from the University of Buenos Aires.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
The experimental group is the one that participates in the intervention
Mindfulness-based intervention
The behavioral intervention was carried out once a week during 60 minutes from May to November, and included mindfulness-based practices sought to foster self-awareness, and dyadic activities sought to awakening subtle perception of the other.
Group activities, which entailed more than two participants, were also conducted to foster empathic collaboration and prosocialness. Diverse collaborative games were carried out in which mutual help was needed for achieving shared goals in an amusing way .
Perspective-taking was encouraged within the group, by sharing each participant's experience, which included expressing how each child had felt (i.e., if neglected, ignored or cared for) and whether they had enjoyed helping their peers or no.
Control group
The control group belonged to the same school but did not participate in the intervention. Instead, they continued with regular curricular classes
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness-based intervention
The behavioral intervention was carried out once a week during 60 minutes from May to November, and included mindfulness-based practices sought to foster self-awareness, and dyadic activities sought to awakening subtle perception of the other.
Group activities, which entailed more than two participants, were also conducted to foster empathic collaboration and prosocialness. Diverse collaborative games were carried out in which mutual help was needed for achieving shared goals in an amusing way .
Perspective-taking was encouraged within the group, by sharing each participant's experience, which included expressing how each child had felt (i.e., if neglected, ignored or cared for) and whether they had enjoyed helping their peers or no.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Children that were present to less than the 80% of the intervention encounters
* Children who were not present at the pre and post measurements points
6 Years
9 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Council of Scientific and Technical Research, Argentina
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paola D'Adamo
Researcher
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paola D'Adamo, PhD
Role: PRINCIPAL_INVESTIGATOR
National Council of Scientific and Technical Research, Argentina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Paola
Bariloche, Río Negro Province, Argentina
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Iglesias S, Jacobsen D, Gonzalez D, Azzara S, Repetto EM, Jamardo J, Gomez SG, Mesch V, Berg G, Fabre B. Hair cortisol: A new tool for evaluating stress in programs of stress management. Life Sci. 2015 Nov 15;141:188-92. doi: 10.1016/j.lfs.2015.10.006. Epub 2015 Oct 22.
Lozada M, Carro N, D'adamo P, Barclay C. Stress management in children: a pilot study in 7 to 9 year olds. J Dev Behav Pediatr. 2014 Feb-Mar;35(2):144-7. doi: 10.1097/DBP.0000000000000026.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CONICET
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.