Recruiting

Harry Potter

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04770168

Conditions

Suicidal Ideation

Suicidal and Self-injurious Behavior

Suicide Attempt

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy Curriculum

Study Details

Brief 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.

Conditions

Suicidal Ideation

Suicidal and Self-injurious Behavior

Suicide Attempt

Study ID

NCT04770168

Start date

Sep 1, 2021

Status verified date

Jul, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

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:

-

Study Design

Enrollment

3204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CBT Curriculum - First Cohort

Students will receive the 3-month cognitive behavioral therapy curriculum in the first half of the academic year.

experimental: CBT Curriculum - Second Cohort (Waitlist Controls)

Students will receive the current school board curriculum as usual for the first half of the academic year, serving as wait-list controls. Since this is a stepped wedge trial, the winter cohort will receive the identical intervention as the fall cohort in the second half of academic year.

Interventions

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.

Primary outcome measure

  • Composite of Self-Reported Suicidal Ideation and Attempts [ Time Frame: Approximately 1-year period of study ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jul 25, 2024

Last verified

Jul, 2024

Keywords

  • Suicidal ideation
  • Suicide attempts
  • Self-harm
  • Mental health literacy curriculum
  • School-based intervention
  • Cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-07-25.