Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04770168
Status:
RECRUITING
Last Update Posted:
2022-05-05
First Post:
2021-02-12
Brief Title:
Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children A Prospective Trial
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children A Prospective Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
School-based mental health literacy interventions have been shown to reduce andor 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 11 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
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 11 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 2000 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 2000 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 eg 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
1 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
2 To determine student and teacher satisfaction with the Harry Potter-based cognitive behavioural therapy curriculum
3 To create a website which achieves sufficient youth and teacher acceptability and youth friendliness for widespread implementation
The secondary hypotheses are as follows
1 Students receiving the curriculum will have a clinically and statistically significant reduction 50 in their presentation to emergency services for self-harmsuicide 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
2 Students receiving the curriculum will have clinically meaningful significantly lower scores 25 on validated instruments for youth depression and anxiety the Revised Childrens 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
3 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 Childrens 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 ie the second cohort will catch up to the first
4 There will be no significant difference between mid-year and year-end measures for the first cohort ie gains will persist at approximately 6 months
5 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 theytheir students benefited from the intervention enjoyed the intervention and would recommend it to others
6 Student focus group data will reflect that students have experienced a qualitative improvement in wellbeing knowledge of mental disorders and resilience following the curriculum
7 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
8 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
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
1 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
2 To determine student and teacher satisfaction with the Harry Potter-based cognitive behavioural therapy curriculum
3 To create a website which achieves sufficient youth and teacher acceptability and youth friendliness for widespread implementation
The secondary hypotheses are as follows
1 Students receiving the curriculum will have a clinically and statistically significant reduction 50 in their presentation to emergency services for self-harmsuicide 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
2 Students receiving the curriculum will have clinically meaningful significantly lower scores 25 on validated instruments for youth depression and anxiety the Revised Childrens 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
3 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 Childrens 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 ie the second cohort will catch up to the first
4 There will be no significant difference between mid-year and year-end measures for the first cohort ie gains will persist at approximately 6 months
5 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 theytheir students benefited from the intervention enjoyed the intervention and would recommend it to others
6 Student focus group data will reflect that students have experienced a qualitative improvement in wellbeing knowledge of mental disorders and resilience following the curriculum
7 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
8 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None