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

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT04824326

Collaborator

Aghia Sophia Children's Hospital of Athens (Other), Institute of Educational Policy (Other), Ministry of Education and Religions, Greece (Other)

Enrollment

Location

Arm

1.7

Actual Duration (Months)

22.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Health Promotion Adolescence	Behavioral: PSAI-CA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 4, 2019

Actual Primary Completion Date :

Mar 22, 2019

Actual Study Completion Date :

Mar 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pythagorean Self Awareness Intervention for Children and Adolescence(PSAI-CA) 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 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.

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Stress reduction [Baseline-2months follow up]
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.

Secondary Outcome Measures

Anxiety reduction [Baseline-2months follow up]
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.
Adherence to Mediterranean diet [Baseline-2months follow up]
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.
Amelioration of lifestyle [Baseline-2months follow up]
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.
Reduce bullying [Baseline-2months follow up]
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.
Investigation of hair cortisol concentrations [Baseline-3months followup]
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.