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

Primary Purpose

Anxiety Symptoms, Depressive Symptoms, Behavioral Problem of Child

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
UPRIGHT intervention
Sponsored by
Kronikgune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Symptoms

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University
  • University of Iceland
  • Fondazione Bruno Kessler
  • Urzad Marszalkowski Wojewodztwa Dolnoslaskiego
  • Kronikgune

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
Change in school resilience capacities
The school resilience is measured by an ad hoc created scale which was validated under the UPRIGHT project setting.
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)
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)
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
Change in the incidence of anxiety
Anxiety is measured by the General Anxiety Disorder (GAD-7)
Change in the incidence of depression
Depression is measured by the Patient Health Questionnaire (PHQ-9)

Full Information

First Posted
May 8, 2019
Last Updated
December 28, 2020
Sponsor
Kronikgune
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03951376
Brief Title
Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers
Acronym
UPRIGHT
Official Title
Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kronikgune
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Symptoms, Depressive Symptoms, Behavioral Problem of Child, Mental Disorder in Adolescence, School Absenteeism, Bullying of Child, Cyberbullying, Violence in Adolescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
4460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
UPRIGHT intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mental well-being
Description
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.
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in resilience capacities for adolescents
Description
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.
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Secondary Outcome Measure Information:
Title
Change in resilience capacities for adults
Description
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
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in school resilience capacities
Description
The school resilience is measured by an ad hoc created scale which was validated under the UPRIGHT project setting.
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in perceived stress
Description
The Perceived Stress Scale (PSS-4) scale is a 4-items tool with 5 response categories (never, almost never, sometimes, fairly often; very often)
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in the quality of life of adolescents
Description
Kidscreen-10 is a 10-items scale with a 5-response options (not at all; slightly; moderately; very extremely)
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in the cases of bullying, substance use, violence and injuries
Description
This outcome is measured by a sub-scale of the Health Behaviour in School-Aged Children (HBSC) including 14-items with 5-response categories
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in the incidence of anxiety
Description
Anxiety is measured by the General Anxiety Disorder (GAD-7)
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.
Title
Change in the incidence of depression
Description
Depression is measured by the Patient Health Questionnaire (PHQ-9)
Time Frame
1st wave: Month 9 (baseline), Month 18 and Month 30. 2nd wave: Month 21 (baseline), Month 30 and Month 42.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlota Las Hayas
Organizational Affiliation
Kronikgune
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
University of Iceland
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland
Facility Name
Fondazione Bruno Kessler
City
Trento
State/Province
Trentino
ZIP/Postal Code
38122
Country
Italy
Facility Name
Urzad Marszalkowski Wojewodztwa Dolnoslaskiego
City
Wrocław
State/Province
Low Silesia
ZIP/Postal Code
50-411
Country
Poland
Facility Name
Kronikgune
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48902
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22008427
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.
Results Reference
background
PubMed Identifier
26371339
Citation
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.
Results Reference
background
PubMed Identifier
22908894
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.
Results Reference
background
PubMed Identifier
11315249
Citation
Masten AS. Ordinary magic. Resilience processes in development. Am Psychol. 2001 Mar;56(3):227-38. doi: 10.1037//0003-066x.56.3.227.
Results Reference
background
PubMed Identifier
17646185
Citation
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.
Results Reference
background
PubMed Identifier
28384523
Citation
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.
Results Reference
background
PubMed Identifier
34417859
Citation
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.
Results Reference
derived
PubMed Identifier
31664974
Citation
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.
Results Reference
derived
Links:
URL
https://www.mentalhealth.org.uk/publications/truth-hurts-report1/
Description
Mental Health Foundation. Truth Hurts: Report of the National Inquiry into Self-Harm Among Young People.
URL
https://casel.org/
Description
Collaborative for academic, social, and emotional learning
URL
https://www.kidsmatter.edu.au/
Description
Department of Health KidsMatter

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

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