Fostering Resilience in Adolescents at Risk.
Condition: Resilience, Psychological
Study type: Interventional

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.
    

Intervention name(s): Fostering Resilience in Adolescents at Risk
Intervention type(s): Behavioral
Intervention description(s): The FRAK training was developed according to ecological framework, empirical evidence and contextual information. The contents, components, pedagogy, and technical elements of FRAK were established based on The Individual & Environmental Resilience Model (IERM). Previous to the intervention, a systematic review and a meta-analysis on Resilience Interventions were performed.
Students will follow a training consisting of six 55-minute sessions: (1) introducing resilience, (2) self-esteem, (3) emotional strategies regulation, (4) social skills, (5) solving problems (6) community resources, social and peers' support.
Other intervention name(s): FRAK
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible schools will be randomly allocated either to an intervention group or control. The clusters were school classrooms (grades 6, 7). For each grade (and 7) there will be several classrooms (clusters) depending of the schools.The randomization procedure will be performed in two steps. First, the schools will be randomly allocated either to an intervention group or control by the external researcher using computer-generated random numbers; second, the external researcher will randomize the intervention group into the different school-levels.
According to the minimum estimated sample size (70 participants/group) and knowing that there are 25 to 30 students per classroom, we will need a minimum of three clusters (classrooms) per group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adolescent; Population at Risk; Psychological Intervention; Clinical Trials, Randomized