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

NCT04770168 | Recruiting

• 1 other identifier: 2200
• Study Type: interventional
• Target: 3,204
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite of Self-Reported Suicidal Ideation and Attempts

  Composite includes self-reported suicidal ideation and self-reported suicide attempts, assessed by questions in the Life Problems Inventory (LPI).

  Approximately 1-year period of study

Secondary Outcomes (6)

• Presentation of Self-harm and Suicide Attempts

  1-year period of study

• Revised Children's Anxiety and Depression Scale

  Approximately 1-year period of study

• Life Problems Inventory Questionnaire

  Approximately 1-year period of study

• Coping Scale for Children and Youth Questionnaire

  Approximately 1-year period of study

• Student Satisfaction Questionnaire and Focus Group

  Approximately 1-year period of study

Study Arms (2)

CBT Curriculum - First Cohort

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy Curriculum

CBT Curriculum - Second Cohort (Waitlist Controls)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy Curriculum

Interventions

Cognitive Behavioral Therapy Curriculum BEHAVIORAL

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.

CBT Curriculum - First Cohort; CBT Curriculum - Second Cohort (Waitlist Controls)

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Links

• Website for the MyOwl website which contains all the lesson plans and student activities for the curriculum.

MeSH Terms

Conditions

Suicidal Ideation; Self-Injurious Behavior; Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Central Study Contacts

Mark Sinyor, MD

CONTACT

416-480-4070; mark.sinyor@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist/Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 25, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

CA (1)