Mental Health Literacy and Academic Performance - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Academic Performance - reading
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of an intervention designed to promote mental health literacy in adolescents. The main questions it aims to answer are:
- Whether this intervention can have an impact on mental health
- Whether this intervention can have an impact on fostering academic performance, particularly in disadvantaged students (i.e., academic resilience)
- Whether this intervention will have differential effectiveness as a function of the delivery format (psychoeducational materials only versus blended)
Participants will receive either an online, automated intervention consisting of psychoeducational materials delivered at predetermined intervals (automated), or the same but with the addition of synchronous or asynchronous psychoeducational sessions held by a licensed psychologist (i.e., blended).
These two conditions will also be compared to a Waitlist, to test if the interventions perform better than no treatment.
详细描述
A Randomized Clinical Trial was designed, involving comparisons at three time-points (pre-intervention, post-intervention, and follow-up) between: (a) Automated delivery of the intervention, (b) Blended format of the intervention, (c) Waitlist (matched control group). Participants will be randomly allocated to one of these three arms, with randomization done at the classroom level.
Appropriate methods for two-level-designs were used to determine sample size requirements for a cRCT with 4 cluster groups (i.e. classrooms) per experimental condition, 22 participants per cluster. For a linear mixed-effects model, a sample size of approximately 88 participants per experimental condition for a total sample size of 264 was sufficient to achieve 80% power to detect an effect size of Cohen's d = 0.4 at an alpha level of 0.05.
Mental health symptomatology (screening items, Attention Deficit/Hyperactivity Disorder (ADHD), depression, anxiety, social anxiety, Posttraumatic Stress Disorder (PTSD), eating disorders), adverse childhood experiences, bullying, social support, mental health stigma, help-seeking, social media engagement, digital addiction, and academic performance will be assessed.
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
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in High School
排除标准
- •Younger than 14 or older than 18
结局指标
主要结局
Academic Performance - reading
时间窗: up to 3 months
Reading comprehension will be assessed with a standardized test for Romanian language, which were sourced from the pool of items from the Progress in International Reading Literacy Study (PIRLS). The test will consist of 26 items, with difficulties ranging from easy to difficult. Higher scores indicate greater academic performance.
Academic Performance - mathematics
时间窗: up to 3 months
Performance in mathematics will be assessed with a standardized test, sourced from the TIMSS, a platform specializing in standardized educational assessment in Romania. The test will consist of 26 items, with difficulties ranging from easy to difficult. Higher scores indicate greater academic performance.
Anxiety symptomatology
时间窗: up to 3 months
The Anxiety Rating scale (Spitzer et al., 2011) consists of eight items, with scores ranging from 0 to 24 and higher scores indicate a worse outcome.
Depressive symptomatology
时间窗: up to 3 months
The Patient Health Questionnaire-9 Depression Scale (PHQ-A, Johnson et al., 2002) is the adolescent-adapted version of the Patient Health Questionnaire and contains ten items. Scores range from 0 to 30 and a higher score is representative of a worse outcome.
次要结局
- Social anxiety symptomatology(up to 3 months)
- Perceived social support(up to 3 months)
- Posttraumatic stress symptomatology(up to 3 months)
- Eating Disorder symptomatology(up to 3 months)
研究者
Cezar Giosan
Associate Professor of Psychology
University of Bucharest