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

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ClinicalTrials.gov Identifier: NCT03951376
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 23, 2019
Sponsor:
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
Information provided by (Responsible Party):
Kronikgune

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2199 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, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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 programme (18 skills). The follow-up phase 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.



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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951376


Contacts
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Contact: Ane Fullaondo 0034944007792 afullaondo@kronikgune.org

Locations
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Denmark
Aarhus University Recruiting
Aarhus C, Denmark, 8000
Contact: Hans Henrik Knoop    004520954960    Knoop@edu.au.dk   
Contact: Mette Marie Ledertoug    004522766339    mele@edu.au.dk   
Principal Investigator: Hans Henrik Knoop         
Iceland
University of Iceland Recruiting
Reykjavík, Iceland, 101
Contact: Anna Sigríríður    003545255327    annaso@hi.is   
Contact: Alda Ingibergsdóttir    003545255327    aldai@hi.is   
Principal Investigator: Anna Sigríríður         
Italy
Fondazione Bruno Kessler Recruiting
Trento, Trentino, Italy, 38122
Contact: Silvia Gabrielli    0039461312477    sgabrielli@fbk.eu   
Contact: Sara Carbone    0039461312477    scarbone@fbk.eu   
Principal Investigator: Silvia Gabrielli         
Poland
Urzad Marszalkowski Wojewodztwa Dolnoslaskiego Recruiting
Wrocław, Low Silesia, Poland, 50-411
Contact: Antoni Zwiefka    0048717704305    antoni.zwiefka@dolnyslask.pl   
Contact: Grzegorz Pytlarz    0048717704305    Grzegorz.Pytlarz@dolnyslask.pl   
Principal Investigator: Antoni Zwiefka         
Spain
Kronikgune Recruiting
Barakaldo, Bizkaia, Spain, 48902
Contact: Ane Fullaondo    0034944007792    afullaondo@kronikgune.org   
Contact: Irantzu Izco    0034944007799    iizco@kronikgune.org   
Principal Investigator: Carlota Las Hayas         
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
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Principal Investigator: Carlota Las Hayas Kronikgune

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kronikgune
ClinicalTrials.gov Identifier: NCT03951376     History of Changes
Other Study ID Numbers: 754919
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders
Depression
Problem Behavior
Bullying
Cyberbullying
Behavioral Symptoms
Aggression