Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorSunnybrook Health Sciences Centre
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy Curriculum
BehavioralThe 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.
Treatment groups
3,204 Participants
are divided into 2 treatment groupsGroup A: CBT Curriculum - First CohortExperimental treatment 1 intervention
Group B: CBT Curriculum - Second Cohort (Waitlist Controls)Experimental treatment 1 intervention
Trial outcomes
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).
Time frame
Approximately 1-year period of studySecondary outcomes
1
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.
Time frame
1-year period of study2
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.
Time frame
Approximately 1-year period of study3
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).
Time frame
Approximately 1-year period of study4
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.
Time frame
Approximately 1-year period of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov