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Clinical Trials/NCT05133115
NCT05133115
Completed
Not Applicable

Resilience School-Based Intervention in Adolescents at Risk: A Clustered Randomized Control Trial.

Consorci Sanitari de Terrassa8 sites in 1 country674 target enrollmentJanuary 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Resilience, Psychological
Sponsor
Consorci Sanitari de Terrassa
Enrollment
674
Locations
8
Primary Endpoint
Child Youth Resilience Measure -32
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to assess the effectiveness of a school-based resilience intervention in adolescents and to understand whether the school training can improve levels of resilience or psychological wellbeing, while reducing depressed mood.

Detailed Description

Background Some studies with adolescents reported the impact of Coronavirus disease 2019 (COVID-19) pandemic on the mental health. In the literature, resilience was related with positive mental health and was defined by some authors as a good mental health and a good psychosocial functioning despite exposure to risk or adversity (Collishaw et al., 2016). Additionally, resilience was also considered important to develop interventions to prevent or treat mental disorders, particularly anxiety, depression, and stress. Schools have been identified as one of the key settings for promoting resilience among children and young populations in this time of COVID-19 pandemic, where social inequalities have become even more evident and depressive symptoms have increased. The purpose of this trial is to assess the effectiveness of a resilience school-based intervention in adolescents and to understand whether the school training can improve levels of resilience or increase psychological wellbeing, while reducing depressed mood. Hypothesis: Adolescents at risk between 12 and 15 years of age who receive a resilience school-based intervention by school nurses, will obtain higher scores on scales of resilience with respect to the control group, just after the intervention and 6-month post-intervention Method: The study is a cluster randomized controlled trial (RCT). Schools that want to participate, will sign an agreement to participate in the project Schools will be randomly allocated in control and intervention groups by external researcher using a computer-generated random numbers. The intervention will be carried out during the school period (January to June 2022), by primary health care nurses who are part of the committee of experts and the research team. Students will follow a specific training consisting of six 55-minute sessions, once a week. The data collection will start in January 2022 and will finish in December 2022. Data will be collected at baseline before the intervention (T1), after 6 weeks post- intervention (T2) and 6 months after intervention as follow-up (T3). The evaluation of the effectiveness of the intervention will be carried out using the psychometric scale CYRM-32 (as the primary outcome) which will allow us to determine changes in resilience. Using SD of the primary outcome CYRM-32 scale, minimum sample size was calculated to be 70 students in each group, using GRANMO (https://www.imim.es/ofertadeserveis/software-public/granmo/). A follow-up loss rate of 10% was estimated.

Registry
clinicaltrials.gov
Start Date
January 30, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Consorci Sanitari de Terrassa
Responsible Party
Principal Investigator
Principal Investigator

Maria Llistosella

PhD

Consorci Sanitari de Terrassa

Eligibility Criteria

Inclusion Criteria

  • Adolescents aged 12 to 15 in a context of risk ( risk of social exclusion; COVID -19 pandemic context)

Exclusion Criteria

  • Adolescents aged 12 to 15 who do not want to participate in the activities of the intervention.
  • Aged \<12 years or \>15 years

Outcomes

Primary Outcomes

Child Youth Resilience Measure -32

Time Frame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months

Changes in level of resilience using the scale Child Youth Resilience Measure -32 (CYRM-32) Child Youth Resilience Measure -32 (CYRM-32) The CYRM-32 includes 32 items is designed to assess resilience in children and young people (aged 12 to 23 years). It is a self-reported measure and for each question, participants use a 5-point Likert scale (1= not at all to 5= a lot (Llistosella et al., 2019).

Brief Resilience Scale

Time Frame: Time 1 baseline, Time 2 post-intervention at week 6 and up to 6 months

Changes in level of resilience using the Brief Resilience scale.

Secondary Outcomes

  • Emotional Regulation Strategies(Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months)
  • Depression Mood(Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months)

Study Sites (8)

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