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

Primary Purpose

Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide Attempt

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy Curriculum
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Suicidal ideation, Suicide attempts, Self-harm, Mental health literacy curriculum, School-based intervention, Cognitive behavioral therapy

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CBT Curriculum - First Cohort

CBT Curriculum - Second Cohort (Waitlist Controls)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Presentation of Self-harm and Suicide Attempts
Presentations 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.
Revised Children's Anxiety and Depression Scale
Assesses youth depression and anxiety. Scale consists of 6 subscales, including Social Phobia (minimum score = 0, maximum score = 27), Panic Disorder (minimum score = 0, maximum score = 27), Major Depression (minimum score = 0, maximum score = 30), Separation Anxiety (minimum score = 0, maximum score = 21), Generalized Anxiety Disorder (minimum score = 0, maximum score = 18), and Obsessive-Compulsive (minimum score = 0, maximum score = 18). Higher scores indicate worse outcome.
Life Problems Inventory Questionnaire
Assesses wellbeing and features borderline personality disorder. Minimum total score = 60. Maximum total score = 300. Higher scores indicate greater dysfunction and worse outcome. Subscales include confusion about self (minimum score = 15, maximum score = 75), impulsivity (minimum score = 15, maximum score = 75), emotional dysregulation (minimum score = 15, maximum score = 75), and interpersonal chaos (minimum score = 15, maximum score = 75).
Coping Scale for Children and Youth Questionnaire
Assesses coping behaviours. Subscales include assistance seeking, cognitive-behavioural problem solving, cognitive avoidance, and behavioural avoidance. Higher scores indicate greater use of that coping dimension.
Student Satisfaction Questionnaire and Focus Group
Composite of responses from self-report questionnaires and focus groups which assesses the degree to which students benefitted from the intervention, enjoyed the intervention, and would recommend to others. Higher scores indicate greater satisfaction.
Teacher Satisfaction Questionnaire and Focus Group
Composite of responses from self-report questionnaires and focus groups which assesses the degree to which teachers think that their students benefitted from the intervention, enjoyed the intervention, and would recommend to others. Higher scores indicate greater satisfaction.

Full Information

First Posted
February 12, 2021
Last Updated
May 4, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04770168
Brief Title
Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial
Official Title
Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
3204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT Curriculum - First Cohort
Arm Type
Experimental
Arm Description
Students will receive the 3-month cognitive behavioral therapy curriculum in the first half of the academic year.
Arm Title
CBT Curriculum - Second Cohort (Waitlist Controls)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy Curriculum
Intervention Description
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 Information:
Title
Composite of Self-Reported Suicidal Ideation and Attempts
Description
Composite includes self-reported suicidal ideation and self-reported suicide attempts, assessed by questions in the Life Problems Inventory (LPI).
Time Frame
Approximately 1-year period of study
Secondary Outcome Measure Information:
Title
Presentation of Self-harm and Suicide Attempts
Description
Presentations 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.
Time Frame
1-year period of study
Title
Revised Children's Anxiety and Depression Scale
Description
Assesses youth depression and anxiety. Scale consists of 6 subscales, including Social Phobia (minimum score = 0, maximum score = 27), Panic Disorder (minimum score = 0, maximum score = 27), Major Depression (minimum score = 0, maximum score = 30), Separation Anxiety (minimum score = 0, maximum score = 21), Generalized Anxiety Disorder (minimum score = 0, maximum score = 18), and Obsessive-Compulsive (minimum score = 0, maximum score = 18). Higher scores indicate worse outcome.
Time Frame
Approximately 1-year period of study
Title
Life Problems Inventory Questionnaire
Description
Assesses wellbeing and features borderline personality disorder. Minimum total score = 60. Maximum total score = 300. Higher scores indicate greater dysfunction and worse outcome. Subscales include confusion about self (minimum score = 15, maximum score = 75), impulsivity (minimum score = 15, maximum score = 75), emotional dysregulation (minimum score = 15, maximum score = 75), and interpersonal chaos (minimum score = 15, maximum score = 75).
Time Frame
Approximately 1-year period of study
Title
Coping Scale for Children and Youth Questionnaire
Description
Assesses coping behaviours. Subscales include assistance seeking, cognitive-behavioural problem solving, cognitive avoidance, and behavioural avoidance. Higher scores indicate greater use of that coping dimension.
Time Frame
Approximately 1-year period of study
Title
Student Satisfaction Questionnaire and Focus Group
Description
Composite of responses from self-report questionnaires and focus groups which assesses the degree to which students benefitted from the intervention, enjoyed the intervention, and would recommend to others. Higher scores indicate greater satisfaction.
Time Frame
Approximately 1-year period of study
Title
Teacher Satisfaction Questionnaire and Focus Group
Description
Composite of responses from self-report questionnaires and focus groups which assesses the degree to which teachers think that their students benefitted from the intervention, enjoyed the intervention, and would recommend to others. Higher scores indicate greater satisfaction.
Time Frame
Approximately 1-year period of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Sinyor, MD
Phone
416-480-4070
Email
mark.sinyor@sunnybrook.ca
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Sinyor, MD
Phone
416-480-4870
Email
mark.sinyor@sunnybrook.ca

12. IPD Sharing Statement

Links:
URL
http://www.myowl.org
Description
Website for the MyOwl website which contains all the lesson plans and student activities for the curriculum.

Learn more about this trial

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

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