Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: a Multi-arm Psychometric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Temperament - Social Orientation (SO)
研究概览
简要总结
Background and study aims:
Mindfulness is a mental state that can be achieved through meditation. So far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. Mindfulness has recently begun to be used in the field of child development. The aim of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperament.
Who can participate? Students attending the fourth or fifth year of primary school
What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions, while the control group will follow routine daily school activities.
Questionnaires will be used to assess temperament, anxiety and depression before and after the intervention.
What are the possible benefits and risks of participating? Benefits of participating in the study may include a lowering of anxiety and depression levels, as well as an improvement of temperament.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 9 to 11 years
- •Children have reasonable comprehension of spoken language and can follow simple instructions
- •Children and their parents are willing to attend all intervention sessions
- •Children and parents have an adequate understanding of English
排除标准
- •Concurrent enrollment in other intervention trials
- •Child or parent regularly practice complementary health interventions such as meditation
结局指标
主要结局
Temperament - Social Orientation (SO)
时间窗: QUIT-SO is measured before and after the 8-week mindfulness intervention
SO dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Negative Emotionality (NE)
时间窗: QUIT-NE is measured before and after the 8-week mindfulness intervention
NE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Temperament - Inhibition to Novelty (IN)
时间窗: QUIT-IN is measured before and after the 8-week mindfulness intervention
IN dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Temperament - Attention (AT)
时间窗: QUIT-AT is measured before and after the 8-week mindfulness intervention
AT dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Positive Emotionality (PE)
时间窗: QUIT-PE is measured before and after the 8-week mindfulness intervention
PE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Motor Activity (MA)
时间窗: QUIT-MA is measured before and after the 8-week mindfulness intervention
MA dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). No overall change is expected in MA scores
次要结局
- Anxiety(TAD for Anxiety is measured before and after the 8-week mindfulness intervention)
- Depression(TAD for Depression is measured before and after the 8-week mindfulness intervention)