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

Depressive Symptoms Clinical Trial

— UPRIGHT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03951376
• Other study ID #: 754919
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Kronikgune
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4460
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Symptoms
• Behavioral Problem of Child
• Bullying
• Bullying of Child
• Cyberbullying
• Depression
• Depressive Symptoms
• Mental Disorder in Adolescence
• Mental Disorders
• Problem Behavior
• School Absenteeism
• Violence in Adolescence

Intervention

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 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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus C
Iceland	University of Iceland	Reykjavík
Italy	Fondazione Bruno Kessler	Trento	Trentino
Poland	Urzad Marszalkowski Wojewodztwa Dolnoslaskiego	Wroclaw	Low Silesia
Spain	Kronikgune	Barakaldo	Bizkaia

Sponsors (10)

Lead Sponsor	Collaborator
Kronikgune	Bruno Kessler Foundation, Daily Centre for Psychiatry and Speech Disorders Poland, Directorate of Health in Iceland, Falkiewicz Specialist Hospital, Norwegian University of Science and Technology, Osakidetza, University of Aarhus, University of Iceland, Urzad Marszalkowski Wojewodztwa Dolnoslaskiego in Poland

Countries where clinical trial is conducted

Denmark,  Iceland,  Italy,  Poland,  Spain, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

Masten AS. Ordinary magic. Resilience processes in development. Am Psychol. 2001 Mar;56(3):227-38. — View Citation

Patel V, Goodman A. Researching protective and promotive factors in mental health. Int J Epidemiol. 2007 Aug;36(4):703-7. Epub 2007 Jul 23. — View Citation

Pina-Camacho L, Del Rey-Mejías Á, Janssen J, Bioque M, González-Pinto A, Arango C, Lobo A, Sarró 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Adolescent mental health care in Europe: state of the art, recommendations, and guidelines by the ADOCARE* network
•   Collaborative for academic, social, and emotional learning
•   Department of Health KidsMatter
•   Mental Health Foundation. Truth Hurts: Report of the National Inquiry into Self-Harm Among Young People.