Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,204
- 试验地点
- 2
- 主要终点
- Composite of Self-Reported Suicidal Ideation and Attempts
研究概览
简要总结
School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. CBT teaches youth about the relationship between their thoughts, feelings, and behaviours, and provides strategies for managing distress. However, there is no established standard mental health literacy curriculum in Ontario. The investigators developed a school-based mental health literacy program that uses the third book in the Harry Potter series ('Harry Potter and the Prisoner of Azkaban') to teach students how to cope with distress through CBT skills. This study will determine whether the Harry Potter-based mental health literacy curriculum diminishes suicidality in students. The study will also determine whether the curriculum decreases depression and anxiety symptoms and improves well-being.
The 3-month intervention is a manual-based curriculum which teaches CBT skills in English class. The website includes video and text-based onboarding to train teachers on all the lessons. Youth complete online exercises for each unit and teachers follow a manual with checklists to preserve high fidelity and standardization of core learning.
Participating classes will be randomized in 1:1 fashion to receive the curriculum in the fall (~Oct-Dec) or the winter (~Feb-Apr). The study will use a stepped-wedge design to introduce the curriculum to classes sequentially testing whether students who receive it in fall will improve at mid-year and those in winter will catch up by year-end. The winter group is included as a "maturational" control to account for changes over the school year that are independent of the intervention and so that order effects of curriculum delivery can be tested. For this design, questionnaires will be administered four times throughout the school year (once before and after each semester), and once more the following year to measure duration of response. At each timepoint, subjects will complete validated questionnaires about suicide attempts and self-harm, anxiety, depression, well-being, and health services usage. Students may also choose to participate in focus groups to collect qualitative data on their experience with the curriculum. With additional consent (Ontario youth only), we will also collect aggregate lists of the Ontario Health Insurance Plan (OHIP) numbers for participating students. These will be provided to the Institute of Clinical Evaluative Sciences (ICES) who will identify sex, age and pre-existing healthcare utilization matched controls from regions that do not adopt the curriculum.
详细描述
Emerging evidence demonstrates that mental health literacy is a critical avenue for primary prevention of mental disorders as it increases awareness and recognition, decreases stigma, and encourages help-seeking. The largest mental health literacy study was conducted in Scandinavia and found that the combination of two lectures, three hours of role-play and an informational booklet reduced suicidal ideation and attempts after one year by approximately half in a cohort of more than 2,000 teenagers. The mental health literacy curriculum was the only intervention that was significantly better than a control group. The intervention has been piloted in more than 2,000 students in Ontario. The intervention is a 'literature study' taught over approximately 3 months in which a class reads the book and learns how distress and depression can manifest. The investigators have conducted two studies - a simple before and after design with 78 participants and a controlled trial with 200 participants who received the intervention and 230 wait list controls. Both indicated an intervention effect on suicide scores as well as improvements on a scale of symptoms of borderline personality disorder (e.g. emotional dysregulation), and depression and anxiety scores). These early findings suggest that this intervention may be a unique way of preventing suicidal ideation and attempts, and improving the mental health of youth across Canada and beyond.
The primary objective of the study is to determine whether the Harry Potter-based cognitive behavioural therapy curriculum diminishes suicidality (ideation and attempts) in students who receive it.
The primary hypothesis is that students receiving the curriculum will have a clinically and statistically significant reduction in rates (≥50%) on a composite measure of a) self-reported suicidal ideation, and b) self-reported suicide attempts.
Furthermore, the secondary objectives for the study are:
- To determine whether the Harry Potter-based cognitive behavioural therapy curriculum decreases depression and anxiety symptoms and improves wellbeing immediately following the curriculum and approximately 6 months later.
- To determine student and teacher satisfaction with the Harry Potter-based cognitive behavioural therapy curriculum
- To create a website which achieves sufficient youth and teacher acceptability and 'youth friendliness' for widespread implementation
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only schools with Grade 7 and 8 classrooms (if requested, we may allow high school teachers/students in Grade 9 - 12 to participate as well)
- •Participants must be able to speak and read fluent English
- •Participants must be willing to complete demographic and clinical self-report questionnaires on anxiety, depression, and general well-being before the intervention and at each timepoint.
排除标准
- 未提供
结局指标
主要结局
Composite of Self-Reported Suicidal Ideation and Attempts
时间窗: Approximately 1-year period of study
Composite includes self-reported suicidal ideation and self-reported suicide attempts, assessed by questions in the Life Problems Inventory (LPI).
次要结局
- Coping Scale for Children and Youth Questionnaire(Approximately 1-year period of study)
- Life Problems Inventory Questionnaire(Approximately 1-year period of study)
- Revised Children's Anxiety and Depression Scale(Approximately 1-year period of study)
- Presentation of Self-harm and Suicide Attempts(1-year period of study)
- Student Satisfaction Questionnaire and Focus Group(Approximately 1-year period of study)
- Teacher Satisfaction Questionnaire and Focus Group(Approximately 1-year period of study)
研究者
Mark Sinyor
Associate Scientist/Psychiatrist
Sunnybrook Health Sciences Centre