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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers

Conditions
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Anxiety Symptoms, Depressive Symptoms, Behavioral Problem of Child, Mental Disorder in Adolescence, School Absenteeism, Bullying of Child, Cyberbullying, Violence in Adolescence

Intervention / Treatment
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* Behavioral: UPRIGHT intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: UPRIGHT intervention<br>* The UPRIGHT intervention design consists of two different phases consecutively implemented in two school years: intensive phase and follow-up phase. During the intensive phase, all stakeholders are trained in the UPRIGHT WELL-BEING FOR US programme (18 skills). The follow-up phase (WELL-BEING FOR ALL) intends not only to maintain the effect of the intensive training in youths, but also to boost the positive mental health atmosphere created in the whole school. To do so, different collective activities will be organized at school level such as celebration of thematic days, activities with the community, and outdoor/indoor activities.<br>|
| No Intervention: Control<br>Schools in the control arm have their usual curricula and are not provided of any intervention resources or support, apart from those in the common daily activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mental well-being | 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. | 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42. | 
| Change in resilience capacities for adolescents | 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. | 1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42. | 

Secondary Outcome Measures

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