Stress Clinical Trial
Official title:
The Effects of Pythagorean Self-Awareness Intervention on Young Adolescents in Primary School-Α One Arm Clinical Trial
Verified date | March 2021 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | March 29, 2019 |
Est. primary completion date | March 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | 4th primary school of Chalandri | Athens |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens | Aghia Sophia Children's Hospital of Athens, Institute of Educational Policy, Ministry of Education and Religions, Greece |
Greece,
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. Review. — View Citation
Klinger DA, Freeman JG, Bilz L, Liiv K, Ramelow D, Sebok SS, Samdal O, Dür 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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline-2months follow up | |
Secondary | 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. | Baseline-2months follow up | |
Secondary | 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. | Baseline-2months follow up | |
Secondary | 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. | Baseline-2months follow up | |
Secondary | 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. | Baseline-3months followup |
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