Mindfulness, Empathy and Social Integration. Its Relation With Chonic Stress
Primary Purpose
Chronic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Mindfulness-based intervention
Sponsored by

About this trial
This is an interventional prevention trial for Chronic Stress Disorder focused on measuring stress, empathy, sociality, cortisol
Eligibility Criteria
Inclusion Criteria:
- Participants having good general health
Exclusion Criteria:
- Children who were taking medication
- 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
Sites / Locations
- Paola
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
The experimental group is the one that participates in the intervention
The control group belonged to the same school but did not participate in the intervention. Instead, they continued with regular curricular classes
Outcomes
Primary Outcome Measures
Change from baseline hair cortisol levels
change form baseline hair cortisol levels at 9 months
change from baseline sociogram levels
Children are asked to say which classmates they would choose as playmates and which ones they would not. The sociogram is completed previous to and after the intervention in both groups. The changes in the number of peers selected (i.e., positive elections) and rejected (i.e., negative elections) reflect changes in the pattern of social relationships of each child. Therefore, if positive elections increase and /or negative elections decrease, social integration improves
Secondary Outcome Measures
Full Information
NCT ID
NCT04177017
First Posted
November 22, 2019
Last Updated
November 25, 2019
Sponsor
National Council of Scientific and Technical Research, Argentina
1. Study Identification
Unique Protocol Identification Number
NCT04177017
Brief Title
Mindfulness, Empathy and Social Integration. Its Relation With Chonic Stress
Official Title
Learning Mindfulness Based Practices, Empathy and Pro-social Behavior in the Educational Field: Its Influence on Health and Interpersonal Relationships
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
June 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Council of Scientific and Technical Research, Argentina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this project is to evaluate the effects of promoting the learning of empathy and pro-social behavior in health and interpersonal relationships in middle-aged children It has been shown that pro-social behavior can decrease chronic stress levels and improve the response of the immune system and the autonomic nervous system. This behavior, which includes a wide variety of actions such as helping, sharing, comforting, informing, emerges early in ontogeny and is closely related to empathic processes. Finding ways to teach how to develop empathy and perspective could contribute to favor interpersonal relationships and health in the school environment, articulating aspects of basic science and applied science. The project not only aims to deepen theoretical aspects of chornic stress, empathy and pro-sociality, but also to develop concrete tools that diminsh chronic stress and foster empathic and cooperative attitudes in the school environment, thus contributing to individual and collective well-being.
Detailed Description
The study will be carried out in primary educational establishments. In the experimental group, the proposed intervention will be conducted during the school year. The control group, with similar characteristics, will carry out regular curricular activities.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stress Disorder
Keywords
stress, empathy, sociality, cortisol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
semi-randmized controlled intervention
Masking
None (Open Label)
Masking Description
The lab that analyzed hair cortisol levels did not know to which group corresponded the samples
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group is the one that participates in the intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group belonged to the same school but did not participate in the intervention. Instead, they continued with regular curricular classes
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Other Intervention Name(s)
Self-awareness practices, and other oriented awareness practicess
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline hair cortisol levels
Description
change form baseline hair cortisol levels at 9 months
Time Frame
through study completion, an average of 9 months
Title
change from baseline sociogram levels
Description
Children are asked to say which classmates they would choose as playmates and which ones they would not. The sociogram is completed previous to and after the intervention in both groups. The changes in the number of peers selected (i.e., positive elections) and rejected (i.e., negative elections) reflect changes in the pattern of social relationships of each child. Therefore, if positive elections increase and /or negative elections decrease, social integration improves
Time Frame
through study completion, an average of 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants having good general health
Exclusion Criteria:
Children who were taking medication
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola D'Adamo, PhD
Organizational Affiliation
National Council of Scientific and Technical Research, Argentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paola
City
Bariloche
State/Province
Rio Negro
ZIP/Postal Code
8400
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26454227
Citation
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.
Results Reference
background
PubMed Identifier
24406660
Citation
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.
Results Reference
result
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Mindfulness, Empathy and Social Integration. Its Relation With Chonic Stress
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