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StressNCT04824326

The Effects of Pythagorean Self-Awareness Intervention on Young Adolescents in Primary School-Α One Arm Clinical Trial

A study testing PSAI-CA in people with Stress and Health Promotion, run by National and Kapodistrian University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Health Promotion, Adolescence
What is being tested?
PSAI-CA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteGreece
Study dates
4 Feb 2019to 29 Mar 2019
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 12 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • attended the 6th Grade of primary education.

Who cannot join

  • . 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • 4th primary school of Chalandri

    Athens

Other trials in Greece

About this study

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.

Being tested
PSAI-CA
Keywords
holistic program, self-awareness, Pythagorean Self-Awareness Intervention, PSAI, stress, adolescence, school, bullying, healthy lifestyle, cognitive intervention
Medical subject headings
Bullying

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSAI-CABehavioural

    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.

Study groups in NCT04824326
Study groupRoleWhat they receive
Pythagorean Self Awareness Intervention for Children and Adolescence(PSAI-CA)ExperimentalThe 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.
Receives: Behavioral: PSAI-CA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline-2months follow up

Secondary outcomes (5)

  1. Anxiety reduction

    State-trait anxiety in children (STAIC): This is a "how-I-feel" questionnaire consisting of two forms of 20 items each which was designed as a research tool for the study of anxiety in children aged 9 to 12 years old. Half of the questions ask children how they feel at a particular moment in time responding to the state-anxiety scale, and the other half set of questions address how they usually feel responding to the trait-anxiety scale. Each item is answered using a 3-point Likert scale ranging from 3=very often to 1=rarely.We expect reduction.

    Measured: Baseline-2months follow up

  2. Adherence to Mediterranean diet

    KIDMED index: This is the Mediterranean diet quality index for children and adolescents which consists of 16 binary items(yes/no). Questions denoting a negative aspect regarding the MD were assigned a value of -1, and those with a positive one were assigned +1. We expect increase.

    Measured: Baseline-2months follow up

  3. Amelioration of lifestyle

    Healthy Lifestyle and Personal Control Questionnaire adapted for Children (HLPCQ): The HLPCQwas developed by the Postgraduate Course Stress Management and Health Promotion, School of Medicine, National and Kapodistrian University of Athens. Daily routine of the respondents was assessed with questions concerning (a) daily sleep, (b) breakfast, (c) lunch and (d) dinner and the regularity of components of their daily schedule Respondents were asked to give their answers ranging from 1 "never" to 4 "very often". Daily habits were assessed with a 4-point scale ranging from 1 "never" to 4 "always" for questions concerning eating habits, physical exercise, participation in sports, relations with relatives, support from friends. We expect increase.

    Measured: Baseline-2months follow up

  4. Reduce bullying

    Peer relations questionnaire for children (PRQ): The questionnaire was developed by Rigby and Slee (1993) and contains three subscales with 20 items. Bully subscale evaluates the tendency of a child to bully others and consists of 6 questions. The victim subscale evaluates the tendency to be victimized by others. The pro social subscale assessed the tendency to act in a pro social or cooperative manner. Four filler items are also included. Participants were asked to give their answers ranging from 1 "never" to 4 "very often". We expect reduction in victim-bully scales and increase in prosocial scale.

    Measured: Baseline-2months follow up

  5. Investigation of hair cortisol concentrations

    Hair cortisol concentrations (HCC): The collection of hair tufts from each study participant took place at baseline and after three months (one month after completion of the intervention). From each participant, hair tuft was collected from the posterior vertexas close to the scalp as possible and stored in a paper envelope at room temperature, pending analysis. Collected hair segments were of one, up to multiple centimeters (cm) of length. Hair has a fairly predictable growth rate of about 1 cm/month. Therefore, the closest part of 1 cm to the scalp approaches the production of last month's cortisol. The second nearest 1 cm section approaches production during the month before, and so on.

    Measured: Baseline-3months followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start4 Feb 2019
  3. Primary completion22 Mar 2019
  4. Study completion29 Mar 2019

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04824326
Sponsor's protocol ID
12413/09-11-2018
Status last verified
Mar 2021
First submitted
27 Mar 2021
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25805788

  • 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.

    PubMed 19401723

  • 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

  • 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.

    PubMed 24030837

  • 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.

    PubMed 30367385

  • 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.

    PubMed 23217646

  • 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.

    PubMed 24743774

  • 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.

    PubMed 26029805

Questions about this trial

What is this clinical trial studying?

A study testing PSAI-CA in people with Stress and Health Promotion, run by National and Kapodistrian University of Athens at 1 site in Greece.

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 5 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 1 Apr 2021. 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 Greece. 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?

Stress reduction (time frame: Baseline-2months follow up). 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 NCT04824326, which also lists 8 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 1 Apr 2021.

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