Clinical trial NCT04824326: The Effects of Pythagorean Self-Awareness Intervention on Young Adolescents in Primary School-Α One Arm Clinical Trial
Official title: The Effects of Pythagorean Self-Awareness Intervention on Young Adolescents in Primary School-Α One Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Health Promotion
Adolescence
Keywords: holistic program
self-awareness
Pythagorean Self-Awareness Intervention
PSAI
stress
adolescence
school
bullying
healthy lifestyle
cognitive intervention
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Aghia Sophia Children's Hospital of Athens
name: Institute of Educational Policy
name: Ministry of Education and Religions, Greece
First posted: 2021-04-01
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* attended the 6th Grade of primary education.

Exclusion Criteria:

* . 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

Primary outcomes:
measure: Stress reduction
timeFrame: Baseline-2months follow up
Secondary outcomes:
measure: Anxiety reduction
timeFrame: Baseline-2months follow up
measure: Adherence to Mediterranean diet
timeFrame: Baseline-2months follow up
measure: Amelioration of lifestyle
timeFrame: Baseline-2months follow up
measure: Reduce bullying
timeFrame: Baseline-2months follow up
measure: Investigation of hair cortisol concentrations
timeFrame: Baseline-3months followup
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 4th primary school of Chalandri
Study officials:
affiliation: National and Kapodistrian University of Athens, Greece
name: Christina Darviri
role: STUDY_DIRECTOR
References:
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