Protocol for the Open Sky School: A Two-arm Clustered Randomized Controlled Trial to Test the Effectiveness of a Nature-based Intervention on Mental Health of Elementary School Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Change from Baseline Child Mental Health at 3 months
研究概览
简要总结
The goal of this a randomized controlled trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. More specifically a two-arm clustered randomized controlled trial will be conducted in elementary schools across Québec, Canada. Following informed consent by teachers, parents and students, schools will be randomly assigned 1:1 to the intervention or the control group with a total of 2500 6th grade students and 100 teachers expected to participate. The primary and secondary research questions are as follows.
The primary research question :
- Is the intervention effective in reducing mental health problems in children from pre-to-post test (Social Behavior Questionnaire: self and teacher reports) ?
The secondary research questions:
- Is the intervention effective in improving children's depression, positive and negative affect, nature connectedness. eco-anxiety and pro-environmental behaviors ?
- Is the intervention effective in improving teachers' well-being and affect ?
- Are the benefits to children sustained benefits at 3 months follow-up ?
- Is the primary question moderated by child's sex, child's disability status, the green space of neighbourhoods, the school's socio-economic position and teacher's experience wtih outdoor education ?
The intervention will take place outdoors in a green-space (2 hours per week for 12 weeks) and include a toolkit of 30 activities to foster well-being (e.g. mindfulness) and academic competencies (e.g. mathematics). The control group will engage in teaching-as-usual and will be provided with the activity toolkit after the trial has been conducted. Questionnaires will be administered to students before, immediately after and 3 months after the intervention in both the control and intervention groups. Teachers in both groups will complete questionnaires before and immediately after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from Baseline Child Mental Health at 3 months
时间窗: Baseline, 3 months
The Social Behavior Questionnaire is a 30 items questionnaire that will be used to assess a range of mental health symptoms in children. The frequency of children's symptoms over the last 2 months is rated on a scale 3-point (never/not true = 0, sometimes/somewhat true = 1, often/very true = 2). Overall symptoms will be examined as outcomes, as well as internalizing symptoms (emotional distress and withdrawal; 11 items), externalizing symptoms (impulsive/hyperactive/inattentive and disruptive behaviors; 13 items), and social behaviors (pro-social behavior and peer relationships; 6 items). Ratings will be obtained by both child and teacher reports which will be analyzed separately.
次要结局
- Change from Baseline Child Mental Health at 6 months(Baseline, 6 months)
- Change from Baseline Child Connection with Nature at 3 Months(Baseline, 3 months)
- Change from Baseline Child Pro-environmental Behaviors at 3 Months(Baseline, 3 months)
- Change from Baseline Teacher Well-being at 3 Months(Baseline, 3 months)
- Teacher's Enjoyment of Outdoor Education(3 months)
- Change from Baseline Child Positive and Negative Affect at 3 months(Baseline, 3 months)
- Change from Baseline Child Positive and Negative Affect at 6 months(Baseline, 6 months)
- Change from Baseline Child Connection with Nature at 6 Months(Baseline, 6 months)
- Child's Appreciation of the Program(3 months)
- Green Space of Neighborhoods(Baseline)
- Disability Status of Children(Baseline)
- Child's Sex(Baseline)
- School's Level of Socio-economic Deprivation(Baseline)
- Change from Baseline Teacher Positive and Negative Affect at 3 Months(Baseline, 3 Months)
- Teacher's Qualifications and Experience(Baseline)
- Teacher's Experience Teaching Outdoors(Baseline)
- Change from Baseline Child Depressive symptoms at 3 months(Baseline, 3 months)
- Change from Baseline Child Depressive Symptoms at 6 months(Baseline, 6 months)
- Change from Baseline Child Pro-environmental Behaviors at 6 Months(Baseline, 6 months)