NCT04824326

Brief Summary

In this one arm clinical trial, students of the 6th grade in a primary school participated in the PSAI for 8 weeks. Self-report questionnaires and hair cortisol concentrations were used for the evaluation of the aforementioned variables at baseline and at the end of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

February 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 27, 2021

Last Update Submit

March 27, 2021

Conditions

StressHealth PromotionAdolescence

Keywords

holistic programself-awarenessPythagorean Self-Awareness InterventionPSAIstressadolescenceschoolbullyinghealthy lifestylecognitive intervention

Outcome Measures

Primary Outcomes (1)

  • Stress reduction

    Stress in Children (SiC) Questionnaire: This is a self-report psychometric instrument that consists of 21 items measuring physical, emotional and symptomatic aspects of stress in children. Each question is answered using a 4-point Likert-type scale (1 = never, 4 = very often). We expect reduction.

    Baseline-2months follow up

Secondary Outcomes (5)

  • Anxiety reduction

    Baseline-2months follow up

  • Adherence to Mediterranean diet

    Baseline-2months follow up

  • Amelioration of lifestyle

    Baseline-2months follow up

  • Reduce bullying

    Baseline-2months follow up

  • Investigation of hair cortisol concentrations

    Baseline-3months followup

Study Arms (1)

Pythagorean Self Awareness Intervention for Children and Adolescence(PSAI-CA)

EXPERIMENTAL

The intervention is based on the principles of the teaching of the ancient Greek philosopher Pythagoras. These principals set a basic framework for behavior on the basis of experiential learning and weekly evaluation of the implementation of 12 virtues. The technique is practiced twice a day(before night sleep and in the morning before getting up from bed) and evolves into five successive steps;1)reading of the 12 virtues and diaphragmatic breathing, 2)recall every event og the day,3)third person visualization and self-observation, 4)self-dialogue "What have I done wrong?", "What have I done right?", "What have I omitted that I ought to have done?" Endorsement or disapproval of actions according to the 12 virtues and the instructions for a healthy lifestyle, 5) next morning brief revision of the previous night's conclusions and setting of goals for the upcoming day.

Behavioral: PSAI-CA

Interventions

PSAI-CABEHAVIORAL

The intervention is based on the principles of the teaching of the ancient Greek philosopher Pythagoras. These principals set a basic framework for behavior on the basis of experiential learning and weekly evaluation of the implementation of 12 virtues. The technique is practiced twice a day(before night sleep and in the morning before getting up from bed) and evolves into five successive steps;1)reading of the 12 virtues and diaphragmatic breathing, 2)recall every event og the day,3)third person visualization and self-observation, 4)self-dialogue "What have I done wrong?", "What have I done right?", "What have I omitted that I ought to have done?" Endorsement or disapproval of actions according to the 12 virtues and the instructions for a healthy lifestyle, 5) next morning brief revision of the previous night's conclusions and setting of goals for the upcoming day.

Pythagorean Self Awareness Intervention for Children and Adolescence(PSAI-CA)

Eligibility Criteria

Age12 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • attended the 6th Grade of primary education.

You may not qualify if:

  • absence of parental informed written consent
  • diagnosis of mental health problemc.
  • presence of any disease that could influence glucocorticoid levels
  • pharmacological treatment that could influence cortisol levels
  • practice of other stress management techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4th primary school of Chalandri

Athens, Greece

Location

Related Publications (8)

  • Klinger DA, Freeman JG, Bilz L, Liiv K, Ramelow D, Sebok SS, Samdal O, Dur W, Rasmussen M. Cross-national trends in perceived school pressure by gender and age from 1994 to 2010. Eur J Public Health. 2015 Apr;25 Suppl 2:51-6. doi: 10.1093/eurpub/ckv027.

    PMID: 25805788BACKGROUND

  • Lupien SJ, McEwen BS, Gunnar MR, Heim C. Effects of stress throughout the lifespan on the brain, behaviour and cognition. Nat Rev Neurosci. 2009 Jun;10(6):434-45. doi: 10.1038/nrn2639. Epub 2009 Apr 29.

    PMID: 19401723BACKGROUND

  • Wigfield a, Lutz SL, Wagner AL. Early Adolescents' development across the Middle School Years: Implications for school Counselors. Professional School Counceling 2005;9(2):112-9. DOI:10.1177/2156759X0500900206

    BACKGROUND

  • Stults-Kolehmainen MA, Sinha R. The effects of stress on physical activity and exercise. Sports Med. 2014 Jan;44(1):81-121. doi: 10.1007/s40279-013-0090-5.

    PMID: 24030837BACKGROUND

  • Simmons S, Limbers CA. Acculturative stress and emotional eating in Latino adolescents. Eat Weight Disord. 2019 Oct;24(5):905-914. doi: 10.1007/s40519-018-0602-2. Epub 2018 Oct 27.

    PMID: 30367385BACKGROUND

  • Ouellet-Morin I, Wong CC, Danese A, Pariante CM, Papadopoulos AS, Mill J, Arseneault L. Increased serotonin transporter gene (SERT) DNA methylation is associated with bullying victimization and blunted cortisol response to stress in childhood: a longitudinal study of discordant monozygotic twins. Psychol Med. 2013 Sep;43(9):1813-23. doi: 10.1017/S0033291712002784. Epub 2012 Dec 10.

    PMID: 23217646BACKGROUND

  • Takizawa R, Maughan B, Arseneault L. Adult health outcomes of childhood bullying victimization: evidence from a five-decade longitudinal British birth cohort. Am J Psychiatry. 2014 Jul;171(7):777-84. doi: 10.1176/appi.ajp.2014.13101401.

    PMID: 24743774BACKGROUND

  • Kendall PC, Peterman JS. CBT for Adolescents With Anxiety: Mature Yet Still Developing. Am J Psychiatry. 2015 Jun;172(6):519-30. doi: 10.1176/appi.ajp.2015.14081061.

    PMID: 26029805BACKGROUND

MeSH Terms

Conditions

Bullying

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Study Officials

  • Christina Darviri

    National and Kapodistrian University of Athens, Greece

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal of 1st primary school,Neo Psychiko,Athens,Greece

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

February 4, 2019

Primary Completion

March 22, 2019

Study Completion

March 29, 2019

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)