- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951376
Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers (UPRIGHT)
Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus C, Denmark, 8000
- Aarhus University
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Reykjavík, Iceland, 101
- University of Iceland
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Trentino
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Trento, Trentino, Italy, 38122
- Fondazione Bruno Kessler
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Low Silesia
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Wrocław, Low Silesia, Poland, 50-411
- Urzad Marszalkowski Wojewodztwa Dolnoslaskiego
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Bizkaia
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Barakaldo, Bizkaia, Spain, 48902
- Kronikgune
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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. |
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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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.
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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The school resilience is measured by an ad hoc created scale which was validated under the UPRIGHT project setting.
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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The Perceived Stress Scale (PSS-4) scale is a 4-items tool with 5 response categories (never, almost never, sometimes, fairly often; very often)
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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Kidscreen-10 is a 10-items scale with a 5-response options (not at all; slightly; moderately; very extremely)
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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This outcome is measured by a sub-scale of the Health Behaviour in School-Aged Children (HBSC) including 14-items with 5-response categories
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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Anxiety is measured by the General Anxiety Disorder (GAD-7)
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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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.
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Depression is measured by the Patient Health Questionnaire (PHQ-9)
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1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carlota Las Hayas, Kronikgune
Publications and helpful links
General Publications
- Kieling C, Baker-Henningham H, Belfer M, Conti G, Ertem I, Omigbodun O, Rohde LA, Srinath S, Ulkuer N, Rahman A. Child and adolescent mental health worldwide: evidence for action. Lancet. 2011 Oct 22;378(9801):1515-25. doi: 10.1016/S0140-6736(11)60827-1. Epub 2011 Oct 16.
- Masten AS. Ordinary magic. Resilience processes in development. Am Psychol. 2001 Mar;56(3):227-38. doi: 10.1037//0003-066x.56.3.227.
- Pina-Camacho L, Del Rey-Mejias A, Janssen J, Bioque M, Gonzalez-Pinto A, Arango C, Lobo A, Sarro S, Desco M, Sanjuan J, Lacalle-Aurioles M, Cuesta MJ, Saiz-Ruiz J, Bernardo M, Parellada M; PEPs Group. Age at First Episode Modulates Diagnosis-Related Structural Brain Abnormalities in Psychosis. Schizophr Bull. 2016 Mar;42(2):344-57. doi: 10.1093/schbul/sbv128. Epub 2015 Sep 14.
- Wathen CN, MacGregor JC, Hammerton J, Coben JH, Herrman H, Stewart DE, MacMillan HL; PreVAiL Research Network. Priorities for research in child maltreatment, intimate partner violence and resilience to violence exposures: results of an international Delphi consensus development process. BMC Public Health. 2012 Aug 21;12:684. doi: 10.1186/1471-2458-12-684.
- Patel V, Goodman A. Researching protective and promotive factors in mental health. Int J Epidemiol. 2007 Aug;36(4):703-7. doi: 10.1093/ije/dym147. Epub 2007 Jul 23. No abstract available.
- 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.
- 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.
- 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.
Helpful Links
- Adolescent mental health care in Europe: state of the art, recommendations, and guidelines by the ADOCARE* network
- Mental Health Foundation. Truth Hurts: Report of the National Inquiry into Self-Harm Among Young People.
- Collaborative for academic, social, and emotional learning
- Department of Health KidsMatter
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 754919
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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