Evaluating the Efficacy and Cost-effectiveness of the School-based Solution-focused Intervention for Mental Health (SIM) in First Year of Upper Secondary School Students
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 727
- 试验地点
- 1
- 主要终点
- Mental well-being
研究概览
简要总结
The Solution-Focused Intervention for Mental Health (SIM) is a universal, school-based programme designed to promote mental well-being among adolescents. Previous feasibility and development studies have supported the acceptability and feasibility of SIM in upper-secondary school settings. The present study is a two-arm, parallel-group cluster-randomised controlled superiority trial evaluating the effectiveness and cost-effectiveness of SIM among upper-secondary school students.
The trial is conducted across six upper-secondary schools in Sweden. Classes are randomised in a 1:1 ratio, stratified by educational programme, to either the SIM intervention or a control condition. Students in the intervention arm receive the SIM programme in addition to usual school provision, while students in the control arm receive a lecture on mental well-being in addition to usual school provision. SIM is a structured, group-based programme applying solution-focused coaching principles and is delivered by trained school staff within ordinary school settings.
The primary outcome is mental well-being, assessed using the Mental Health Continuum-Short Form. Secondary outcomes include mental health problems and perceived stress, and solution-building capability is examined as a potential mediator of intervention effects. Outcomes are assessed at baseline, immediately post-intervention, and at approximately six- and nine-month follow-up. The trial also includes process and implementation measures to assess intervention delivery and support interpretation of trial outcomes.
By evaluating SIM under routine school conditions, the study aims to provide evidence on the effectiveness and cost-effectiveness of a scalable school-based approach to promoting adolescent mental well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Students were not informed of their allocated study condition until consent and baseline assessment had been completed. Thereafter, masking of participants and intervention providers was not feasible due to the nature of the intervention.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •first and second-year upper secondary school students
- •students enrolled in regular school programs
排除标准
- •students with insufficient knowledge of the Swedish language
- •students who are absent during the information meeting or could not be reached for a separate meeting to receive the accurate information
- •students who are absent at the start session or cannot be reached to complete the baseline prior to the first themed SIM session
- •students who for various reasons (e.g. functional impairments) are unable to participate in an ordinary teaching situation.
研究组 & 干预措施
SIM intervention
Students participating in the school-based SIM program designed to promote mental well-being.
干预措施: The Solution-focused Intervention for Mental health (SIM) (Behavioral)
Control condition
Students receiving a lecture on mental well-being along with usual student health provision.
结局指标
主要结局
Mental well-being
时间窗: This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.
The difference in mental well-being between the intervention and control arms as measured by the Mental Health Continuum - Short Form. The total score ranges from 0 to 70, with higher scores indicating better mental well-being.
次要结局
- Mental problems(This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.)
- Perceived stress(This study will examine participants from enrollment to the end of the 10-week intervention, as well as at six- and nine-month follow-ups.)