Fostering Resilience in Adolescents at Risk.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Resilience, Psychological

Intervention / Treatment
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* Behavioral: Fostering Resilience in Adolescents at Risk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Schools with adolescents aged 12 to 15 in a context at risk. They will follow the intervention for 6 weeks (6 sessions, once a week). | Behavioral: Fostering Resilience in Adolescents at Risk<br>* 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.<br>* Other names: FRAK;|
| No Intervention: Control Group<br>Schools in the control group will be all waitlisted to receive the intervention during the following academic year should it prove effectiveness. They will fill in the same research questionnaires as the Intervention group and at the same time period (January to December 2022). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Youth Resilience Measure -32 | 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). | Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months | 
| Brief Resilience Scale | Changes in level of resilience using the Brief Resilience scale. | Time 1 baseline, Time 2 post-intervention at week 6 and up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Regulation Strategies | Emotion Regulation Questionnaire (ERQ) The ERQ is a self-report questionnaire, adapted in Spain by Cabello et al. (2013). It will be used to assess two emotion regulation strategies: cognitive reappraisal (6 items) and expressive suppression (4 items). Participants will answer using a 7-point Likert scale (1= strongly disagree, 7= strongly agree). | Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months | 
| Depression Mood | Item Are You Depressed or Sad? This item will assess the depression mood of the participants. It was adapted from the Are you depressed? Screening for depression in the terminally ill (Chochinov et al., 1997) and it is evaluate through numeric scale of 0-10 (0-not depressed, 10-worst possible depression). | Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Population at Risk, Psychological Intervention, Clinical Trials, Randomized