Resilience School-Based Intervention in Adolescents at Risk: A Clustered Randomized Control Trial.
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
- 是
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
Maria Llistosella
PhD
Consorci Sanitari de Terrassa
