NCT03951376

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
5 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

4 years

First QC Date

May 8, 2019

Last Update Submit

December 28, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (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.

  • 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.

  • Change in perceived stress

    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

    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

    1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents from 1st grade (12-14 years of age) studying in the participating schools, their families and teachers of these adolescents.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aarhus University

Aarhus C, 8000, Denmark

Location

University of Iceland

Reykjavik, 101, Iceland

Location

Fondazione Bruno Kessler

Trento, Trentino-Alto Adige, 38122, Italy

Location

Urzad Marszalkowski Wojewodztwa Dolnoslaskiego

Wroclaw, Low Silesia, 50-411, Poland

Location

Kronikgune

Barakaldo, Bizkaia, 48902, Spain

Location

Related Publications (8)

  • 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.

    PMID: 22008427BACKGROUND
  • 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.

    PMID: 26371339BACKGROUND
  • 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.

    PMID: 22908894BACKGROUND
  • Masten AS. Ordinary magic. Resilience processes in development. Am Psychol. 2001 Mar;56(3):227-38. doi: 10.1037//0003-066x.56.3.227.

    PMID: 11315249BACKGROUND
  • 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.

    PMID: 17646185BACKGROUND
  • 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.

    PMID: 28384523BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressionCyberbullying

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorBullyingAggressionHarassment, Non-SexualSocial Behavior

Study Officials

  • Carlota Las Hayas

    Biosistemak Institute for Health Systems Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 15, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations