Feasibility, Effectiveness and Overall Impact of the Hope@School Universal Prevention Program Promoting Child and Adolescent Mental Health in Schools: A Two-arm Randomized Controlled Trial Across Seven European Countries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,220
- 主要终点
- KIDSCREEN-27 Child version
研究概览
简要总结
This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).
The primary objectives of the study are:
To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health.
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
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 8 and 18 years
- •Attends school included in the study
- •Consents to participate
排除标准
- •Younger than 8 and older than 18 years
结局指标
主要结局
KIDSCREEN-27 Child version
时间窗: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Level of child-rated quality of life as measured by a questionnaire
次要结局
- Mental Health-Promoting Knowledge (MHPK-10)(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
- KIDSCREEN-27 Parent version(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
- Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
- Digital Addiction Scale for Children (DASC)(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
- Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2(Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint))
研究者
Jens Högström
Associate professor
Karolinska Institutet