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Clinical Trials in Canada / NCT04770168
Recruiting Not applicable

Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial

NCT04770168 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2021-09-01
Last updated
2024-07-25

Condition(s) studied

Suicidal IdeationSuicidal and Self-injurious BehaviorSuicide Attempt

Investigational drug(s) / intervention(s)

Cognitive Behavioral Therapy Curriculum

Cognitive Behavioral Therapy Curriculum: The 3-month Harry Potter curriculum is delivered by trained teachers and includes lessons on a) risk factors that can contribute to emotional distress, b) how depression and anxiety manifest and how to access support/treatment, c) cognitive distortions, how they differ from rational thoughts and basic cognitive restructuring techniques, d) crisis planning including personalized "stressbusters" and "hope kits", and e) how to be resilient.

Study summary

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.

Eligibility

Sex
ALL
Min age
11 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Health Sciences Centre Toronto Ontario Recruiting

More Sunnybrook Health Sciences Centre trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04770168 on ClinicalTrials.gov ↗ ← All trials in Canada