Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Suicidal and Self-injurious Behavior
  • Suicidal Ideation
  • Suicide Attempt
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study employs a stepped wedge research design, allowing for both groups to receive the same cognitive behavioural therapy curriculum but during different time periods. Half the classes will receive the curriculum during the first half of the academic year and the rest of the classes will receive the curriculum during the second half of the academic year.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 11 years and 18 years
Gender
Both males and females

Description

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 th...

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 The secondary hypotheses are as follows: Students receiving the curriculum will have a clinically and statistically significant reduction (?50%) in their presentation to emergency services for self-harm/suicide attempts according to Ontario health administrative data (held in the Institute for Clinical Evaluative Services (ICES) repository). This is only applicable to research participants in Ontario. Students receiving the curriculum will have clinically meaningful, significantly lower scores (?25%) on validated instruments for youth depression and anxiety (the Revised Children's Anxiety and Depression Scale - RCADS), and wellbeing (the Life Problems Inventory - LPI) immediately after receiving it. Moreover, students will report a significant improvement (?25%) on the Coping Scale for Children and Youth (CSCY) questionnaire. Students in the first cohort (students who receive the curriculum in the fall semester) will have clinically meaningful, significantly lower scores (?25%) on validated instruments for youth depression and anxiety (the Revised Children's Anxiety and Depression Scale - RCADS) and wellbeing (the Life Problems Inventory - LPI; Coping Scale for Children and Youth - CSCY) than the second cohort (students who receive the curriculum in the winter semester) at the mid-year point, but the two groups will not differ statistically at year end (i.e. the second cohort will catch up to the first). There will be no significant difference between mid-year and year-end measures for the first cohort (i.e., gains will persist at approximately 6 months). Student and teacher scores will both be high (mean ?6 on 7-point Likert scales) on satisfaction questionnaires asking the degree to which they think they/their students benefited from the intervention, enjoyed the intervention, and would recommend it to others. Student focus group data will reflect that students have experienced a qualitative improvement in wellbeing, knowledge of mental disorders and resilience following the curriculum. Teacher interview data will reflect that teachers found the curriculum easy to implement and useful for imparting both mental health and general literacy to their students. Students and teachers receiving the curriculum will achieve a mean score of ?4 per question on a 5-point Likert-based questionnaire assessing acceptability and satisfaction as well as positive qualitative feedback.

Tracking Information

NCT #
NCT04770168
Collaborators
Not Provided
Investigators
Not Provided