Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers (UPRIGHT)
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|ClinicalTrials.gov Identifier: NCT03951376|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Symptoms Depressive Symptoms Behavioral Problem of Child Mental Disorder in Adolescence School Absenteeism Bullying of Child Cyberbullying Violence in Adolescence||Behavioral: UPRIGHT intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2199 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Masking:||None (Open Label)|
|Official Title:||Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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
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 programme (18 skills). The follow-up phase 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.
No Intervention: Control
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.
- Change in mental well-being [ Time Frame: 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 [ Time Frame: 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.
- Change in resilience capacities for adults [ Time Frame: 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 school resilience capacities [ Time Frame: 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 [ Time Frame: 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 quality of life of adolescents [ Time Frame: 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 the cases of bullying, substance use, violence and injuries [ Time Frame: 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 [ Time Frame: 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 the incidence of depression [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951376
|Contact: Ane Fullaondoemail@example.com|
|Aarhus C, Denmark, 8000|
|Contact: Hans Henrik Knoop 004520954960 Knoop@edu.au.dk|
|Contact: Mette Marie Ledertoug 004522766339 firstname.lastname@example.org|
|Principal Investigator: Hans Henrik Knoop|
|University of Iceland||Recruiting|
|Reykjavík, Iceland, 101|
|Contact: Anna Sigríríður 003545255327 email@example.com|
|Contact: Alda Ingibergsdóttir 003545255327 firstname.lastname@example.org|
|Principal Investigator: Anna Sigríríður|
|Fondazione Bruno Kessler||Recruiting|
|Trento, Trentino, Italy, 38122|
|Contact: Silvia Gabrielli 0039461312477 email@example.com|
|Contact: Sara Carbone 0039461312477 firstname.lastname@example.org|
|Principal Investigator: Silvia Gabrielli|
|Urzad Marszalkowski Wojewodztwa Dolnoslaskiego||Recruiting|
|Wrocław, Low Silesia, Poland, 50-411|
|Contact: Antoni Zwiefka 0048717704305 email@example.com|
|Contact: Grzegorz Pytlarz 0048717704305 Grzegorz.Pytlarz@dolnyslask.pl|
|Principal Investigator: Antoni Zwiefka|
|Barakaldo, Bizkaia, Spain, 48902|
|Contact: Ane Fullaondo 0034944007792 firstname.lastname@example.org|
|Contact: Irantzu Izco 0034944007799 email@example.com|
|Principal Investigator: Carlota Las Hayas|
|Principal Investigator:||Carlota Las Hayas||Kronikgune|