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Completed

NCT Number: NCT05133115

Fostering Resilience in Adolescents at Risk.

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.

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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School Antoni Ubach, Terrassa, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fostering Resilience in Adolescents at Risk

Behavioral

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 names: FRAK

Primary outcomes

  1. 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).

  2. 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

  1. Emotional Regulation Strategies

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

    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).

  2. Depression Mood

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

    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).

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Collaborators

  • Department of Health, Generalitat de Catalunya

Registry information

Official study title

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

Acronym: FRAK

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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