Chronic Stress DisorderNCT04177017
Mindfulness, Empathy and Social Integration. Its Relation With Chonic Stress
A study testing Mindfulness-based intervention in people with Chronic Stress Disorder, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress Disorder
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Mar 2017to 23 Jun 2018
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants having good general health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Mindfulness Based Practices, Empathy and Pro-social Behavior in the Educational Field: Its Influence on Health and Interpersonal Relationships
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.
Read the 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:
- Sociometric questionnaire.
Stress levels are quantified through:
- 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
- Chronic Stress Disorder
- Being tested
- Mindfulness-based intervention
- Keywords
- stress, empathy, sociality, cortisol
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
Also called Self-awareness practices, and other oriented awareness practicess
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group is the one that participates in the intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hair cortisol levels
change form baseline hair cortisol levels at 9 months
Measured: 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
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 Mar 2017
- Primary completion30 Nov 2017
- Study completion23 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Stress DisorderStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- semi-randmized controlled intervention
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Paola D'Adamo, National Council of Scientific and Technical Research, Argentina
- Investigators
- Paola D'Adamo, PhD, Principal investigator, National Council of Scientific and Technical Research, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177017
- Sponsor's protocol ID
- CONICET
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26454227Lozada 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.
PubMed 24406660
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Mindfulness Based Practices, Empathy and Pro-social Behavior in the Educational Field: Its Influence on Health and Interpersonal Relationships
- ClinicalTrials.gov ID
- NCT04177017
- Acronym / sponsor ID
- CONICET
- Conditions
- Chronic Stress Disorder
- Keywords
- stress, empathy, sociality, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 23 Jun 2018 (actual)
- First posted
- 26 Nov 2019 (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.
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:
- Sociometric questionnaire.
Stress levels are quantified through:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- semi-randmized controlled intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Mindfulness-based interventionThe experimental group is the one that participates in the 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 |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants having good general health
Key exclusion criteria (3 listed)
- 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
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-based interventionAlso: Self-awareness practices, and other oriented awareness practicessThe 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. | Behavioural | Experimental group |
Primary outcome
Change from baseline hair cortisol levels
Time frame: through study completion, an average of 9 months
change form baseline hair cortisol levels at 9 months
change from baseline sociogram levels
Time frame: through study completion, an average of 9 months
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
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 26 Nov 2019.
- Background: PubMed 26454227Iglesias 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 publication: PubMed 24406660Lozada 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.
- 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.
Paola D'Adamo, PhD principal investigator
National Council of Scientific and Technical Research, Argentina
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-based intervention in people with Chronic Stress Disorder, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
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 1 inclusion and 3 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 26 Nov 2019. 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 Argentina. 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?
Change from baseline hair cortisol levels (time frame: through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177017, which also lists 2 linked publications.
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 26 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.