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出境医 / 临床实验 / Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers (UPRIGHT)

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

Study Description
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.

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

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4460 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
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.

 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.
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.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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)

  5. 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

  6. 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)

  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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Denmark
Aarhus University
Aarhus C, Denmark, 8000
Iceland
University of Iceland
Reykjavík, Iceland, 101
Italy
Fondazione Bruno Kessler
Trento, Trentino, Italy, 38122
Poland
Urzad Marszalkowski Wojewodztwa Dolnoslaskiego
Wrocław, Low Silesia, Poland, 50-411
Spain
Kronikgune
Barakaldo, Bizkaia, Spain, 48902
Sponsors and Collaborators
Kronikgune
Osakidetza
Bruno Kessler Foundation
Urzad Marszalkowski Wojewodztwa Dolnoslaskiego in Poland
Norwegian University of Science and Technology
Directorate of Health in Iceland
University of Aarhus
University of Iceland
Daily Centre for Psychiatry and Speech Disorders Poland
Falkiewicz Specialist Hospital
Investigators
Layout table for investigator information
Principal Investigator: Carlota Las Hayas Kronikgune
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date December 30, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers
Official Title  ICMJE Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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)
Primary Purpose: Prevention
Condition  ICMJE
  • Anxiety Symptoms
  • Depressive Symptoms
  • Behavioral Problem of Child
  • Mental Disorder in Adolescence
  • School Absenteeism
  • Bullying of Child
  • Cyberbullying
  • Violence in Adolescence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: UPRIGHT intervention
  • 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.
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. Review.
  • 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.
  • 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.
  • Masten AS. Ordinary magic. Resilience processes in development. Am Psychol. 2001 Mar;56(3):227-38.
  • 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.
  • 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, 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, González-Pinto A, Vergara I, González 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 28, 2020) 		4460
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		2199
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Iceland,   Italy,   Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951376
Other Study ID Numbers  ICMJE 754919
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kronikgune
Study Sponsor  ICMJE Kronikgune
Collaborators  ICMJE
  • Osakidetza
  • Bruno Kessler Foundation
  • Urzad Marszalkowski Wojewodztwa Dolnoslaskiego in Poland
  • Norwegian University of Science and Technology
  • Directorate of Health in Iceland
  • University of Aarhus
  • University of Iceland
  • Daily Centre for Psychiatry and Speech Disorders Poland
  • Falkiewicz Specialist Hospital
Investigators  ICMJE
Principal Investigator: Carlota Las Hayas Kronikgune
PRS Account Kronikgune
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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