NCT04177017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

November 22, 2019

Last Update Submit

November 25, 2019

Conditions

Keywords

stressempathysocialitycortisol

Outcome Measures

Primary Outcomes (2)

  • Change from baseline hair cortisol levels

    change form baseline hair cortisol levels at 9 months

    through study completion, an average of 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

    through study completion, an average of 9 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group is the one that participates in the intervention

Behavioral: Mindfulness-based intervention

Control group

NO INTERVENTION

The control group belonged to the same school but did not participate in the intervention. Instead, they continued with regular curricular classes

Interventions

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.

Also known as: Self-awareness practices, and other oriented awareness practicess
Experimental group

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants having good general health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paola

Bariloche, Río Negro Province, 8400, Argentina

Location

Related Publications (2)

  • 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.

    PMID: 26454227BACKGROUND
  • 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.

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Paola D'Adamo, PhD

    National Council of Scientific and Technical Research, Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The lab that analyzed hair cortisol levels did not know to which group corresponded the samples
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: semi-randmized controlled intervention
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 26, 2019

Study Start

March 20, 2017

Primary Completion

November 30, 2017

Study Completion

June 23, 2018

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations