Clinical trial NCT03951376: Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers
Official title: Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Behavioral Problem of Child
Mental Disorder in Adolescence
School Absenteeism
Bullying of Child
Cyberbullying
Violence in Adolescence
Lead sponsor: Biosistemak Institute for Health Systems Research
Sponsor class: OTHER
Collaborators: name: Osakidetza
name: Bruno Kessler Foundation
name: Urzad Marszalkowski Wojewodztwa Dolnoslaskiego in Poland
name: Norwegian University of Science and Technology
name: Directorate of Health in Iceland
name: University of Aarhus
name: University of Iceland
name: Daily Centre for Psychiatry and Speech Disorders Poland
name: Falkiewicz Specialist Hospital
First posted: 2019-05-15
Enrollment: 4460
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster, randomized, controlled (two parallel groups) trial. The intervention is conducted in two phases (intensive phase and follow-up phase). The intervention is repeated 2 times during 3 years (2 waves)
Primary purpose: PREVENTION

Brief summary: Adolescence is a period of many physical, mental, emotional, and social changes. It is also associated with risk behaviour conducts. Nonetheless, not all youths under disadvantage, adversity, or exposure to risk factors experience negative mental health outcomes. The concept of RESILIENCE provides one possible explanation for the ability of some individuals to maintain positive mental health. Resilience is thus the ability of an individual or community to adapt to life challenges or adversities while maintaining mental health and well-being. The increasing prevalence of mental disorders amongst children (around 10-20% of young people) makes positive mental health promotion in schools necessary through intervention programmes. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is a research and innovation project funded by the European Union´s Horizon 2020 programme (No. 754919). UPRIGHT general aim is to promote mental well-being and prevent mental disorders in youth by enhancing resilience capacities. It has been designed as a whole school approach addressing early adolescents, their families and the school community to finally create a real mental well-being culture at schools.

Detailed description: The operational objectives of UPRIGHT are:

* to co-create (involving adolescents, families, school staff, clinicians, policy makers) an innovative resilience holistic program in schools for the promotion of mental health in youth between 12 and 14 years;
* to deploy an intervention in five different pan-European regions;
* to better understand the natural history of mental disorders according to the resilience level and provide evidence of specific resilience factors promoting positive mental well-being longitudinally;
* to demonstrate the effectiveness and predict future impact of an intervention in terms of improvement of quality of life, mental well-being, and academic performance, and a reduction of absenteeism and bullying cases;
* to transfer the programme to Europe and beyond by disseminating the results and enabling innovative action plans for mental well-being in the youth.

The UPRIGHT programme´s conceptual framework is structured in four different domains including skills for coping, efficacy, social and emotional learning and mindfulness practice. The intervention was developed by an innovative co-creation process (co-design, co-production and co-customization) participating five European regions representative of the cultural and socioeconomic variability (Lower Silesian in Poland, Basque Country in Spain, Trento in Italy, Denmark and Reykjavik capitol area in Iceland).

Eligibility criteria: Inclusion Criteria:

* Adolescents from 1st grade (12-14 years of age) studying in the participating schools, their families and teachers of these adolescents.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in mental well-being
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in resilience capacities for adolescents
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Secondary outcomes:
measure: Change in resilience capacities for adults
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in school resilience capacities
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in perceived stress
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in the quality of life of adolescents
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in the cases of bullying, substance use, violence and injuries
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in the incidence of anxiety
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
measure: Change in the incidence of depression
timeFrame: 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University
city: Reykjavík
country: Iceland
facility: University of Iceland
city: Trento
country: Italy
facility: Fondazione Bruno Kessler
state: Trentino
city: Wrocław
country: Poland
facility: Urzad Marszalkowski Wojewodztwa Dolnoslaskiego
state: Low Silesia
city: Barakaldo
country: Spain
facility: Kronikgune
state: Bizkaia
Study officials:
affiliation: Biosistemak Institute for Health Systems Research
name: Carlota Las Hayas
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dray J, Bowman J, Campbell E, Freund M, Hodder R, Wolfenden L, Richards J, Leane C, Green S, Lecathelinais C, Oldmeadow C, Attia J, Gillham K, Wiggers J. Effectiveness of a pragmatic school-based universal intervention targeting student resilience protective factors in reducing mental health problems in adolescents. J Adolesc. 2017 Jun;57:74-89. doi: 10.1016/j.adolescence.2017.03.009. Epub 2017 Apr 3.
citation: Las-Hayas C, Mateo-Abad M, Vergara I, Izco-Basurko I, Gonzalez-Pinto A, Gabrielli S, Mazur I, Hjemdal O, Gudmundsdottir DG, Knoop HH, Olafsdottir AS, Fullaondo A, Gonzalez N, Mar-Medina J, Krzyzanowski D, Morote R, Anyan F, Ledertoug MM, Tidmand L, Arnfjord UB, Kaldalons I, Jonsdottir BJ, de Manuel Keenoy E; UPRIGHT Consortium. Relevance of well-being, resilience, and health-related quality of life to mental health profiles of European adolescents: results from a cross-sectional analysis of the school-based multinational UPRIGHT project. Soc Psychiatry Psychiatr Epidemiol. 2022 Feb;57(2):279-291. doi: 10.1007/s00127-021-02156-z. Epub 2021 Aug 21.
citation: Las Hayas C, Izco-Basurko I, Fullaondo A, Gabrielli S, Zwiefka A, Hjemdal O, Gudmundsdottir DG, Knoop HH, Olafsdottir AS, Donisi V, Carbone S, Rizzi S, Mazur I, Krolicka-Deregowska A, Morote R, Anyan F, Ledertoug MM, Tange N, Kaldalons I, Jonsdottir BJ, Gonzalez-Pinto A, Vergara I, Gonzalez N, Mar Medina J, de Manuel Keenoy E; UPRIGHT consortium. UPRIGHT, a resilience-based intervention to promote mental well-being in schools: study rationale and methodology for a European randomized controlled trial. BMC Public Health. 2019 Oct 29;19(1):1413. doi: 10.1186/s12889-019-7759-0.