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临床试验/NCT05133115
NCT05133115已完成不适用

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

Consorci Sanitari de Terrassa8 个研究点 分布在 1 个国家目标入组 674 人开始时间: 2022年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
674
试验地点
8
主要终点
Child Youth Resilience Measure -32

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

No-blinded participant groups and personnel (research team).

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Child Youth Resilience Measure -32

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Llistosella

PhD

Consorci Sanitari de Terrassa

研究点 (8)

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