Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers

Not Applicable

• Conditions: Anxiety Symptoms; Mental Disorder in Adolescence; Violence in Adolescence; Depressive Symptoms; Behavioral Problem of Child; Cyberbullying; School Absenteeism; Bullying of Child
• Interventions: Behavioral: UPRIGHT intervention

• Registration Number: NCT03951376
• Lead Sponsor: Kronikgune

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).

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	UPRIGHT intervention	The schools in this arm will implement the UPRIGHT programme (18 skills related to Mindfulness, Coping, Efficacy and Social and emotional learning) during a minimum of 18 sessions and a maximum of 24 in a period of 6 months, which will be conducted by teachers to adolescents of 1st grade (12-14 years of age). Teachers will be trained by the UPRIGHT team at the beginning of the school year (3 months) and families will have a combination of face to face training and online training throughout the UPRIGHT platform.

Primary Outcome Measures

Name	Time	Method
Change in mental well-being	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	The mental well-being is measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-14) scale in adolescents, families and teachers. This is a 14-item scale with 5 response categories.
Change in resilience capacities for adolescents	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	The resilience is measured by the Resilience Scale for Adolescents (READ-28) for adolescents and designed as a 28-items scale with 5 response categories.

Secondary Outcome Measures

Name	Time	Method
Change in the quality of life of adolescents	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	Kidscreen-10 is a 10-items scale with a 5-response options (not at all; slightly; moderately; very extremely)
Change in school resilience capacities	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	The school resilience is measured by an ad hoc created scale which was validated under the UPRIGHT project setting.
Change in perceived stress	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	The Perceived Stress Scale (PSS-4) scale is a 4-items tool with 5 response categories (never, almost never, sometimes, fairly often; very often)
Change in the cases of bullying, substance use, violence and injuries	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	This outcome is measured by a sub-scale of the Health Behaviour in School-Aged Children (HBSC) including 14-items with 5-response categories
Change in the incidence of anxiety	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	Anxiety is measured by the General Anxiety Disorder (GAD-7)
Change in resilience capacities for adults	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	The resilience is measured by the Resilience Scale for adults (RSA-33) for adults and designed as a 33-items scale with 5 response categories
Change in the incidence of depression	1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.	Depression is measured by the Patient Health Questionnaire (PHQ-9)

Trial Locations

Locations (5)

University of Iceland; 🇮🇸 Reykjavík, Iceland

Kronikgune; 🇪🇸 Barakaldo, Bizkaia, Spain

Urzad Marszalkowski Wojewodztwa Dolnoslaskiego; 🇵🇱 Wrocław, Low Silesia, Poland

Aarhus University; 🇩🇰 Aarhus C, Denmark

Fondazione Bruno Kessler; 🇮🇹 Trento, Trentino, Italy