Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001582741
Ethics application status
Approved
Date submitted
5/12/2022
Date registered
22/12/2022
Date last updated
4/08/2024
Date data sharing statement initially provided
22/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A school-based randomised controlled trial of a universal mental health prevention program: OurFutures Mental Health
Scientific title
A school-based randomised controlled trial investigating the effect of the universal mental health prevention program, OurFutures Mental Health, on mental health literacy and symptoms of depression and anxiety
Secondary ID [1] 308284 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 328068 0
Condition category
Condition code
Mental Health 325128 325128 0 0
Anxiety
Mental Health 325129 325129 0 0
Depression
Public Health 325130 325130 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: OurFutures Mental Health

OurFutures Mental Health is a six-lesson, online intervention. It draws on cognitive-behavioural principles and incorporates psychoeducation and self-management and interpersonal skill acquisition. The intervention aims to increase mental health knowledge and, for those who report anxiety and depression symptoms at baseline, reduce anxiety and depression symptoms. This module also aims to improve important secondary social, emotional, and behavioural outcomes, including general well-being and help-seeking.

Each lesson comprises two components: a 20-minute online cartoon component completed individually by students, followed by a 20-minute teacher-delivered group activity which reinforces cartoon content and facilitates interactive classroom discussion. The first part of each lesson is completed individually over the internet. During this part of the lesson students are engaged through cartoon story lines that impart information about mental health problems, normative feelings of being anxious or feeling down, identifying and effectively dealing with anxiety and depression symptoms. The cartoons follow a group of Australian school students, who are navigating daily life and mental health concerns. The second part of each lesson is a group or class activity delivered by the teacher, and reinforces the information in the cartoons, while allowing interactive communication between students. Teachers are provided with a training manual containing the activities, implementation guidelines, links to the education syllabus and summaries for each lesson. This training manual was designed specifically for this study.

These 6 x 40-minute lessons will be delivered at school, over the course of a school term (i.e., 10 weeks). For each lesson, teachers will complete a logbook to assess adherence and fidelity to the intervention. Student adherence to the cartoons will be automatically captured by the online cartoon portal.

A previous version of the OurFutures Mental Health module was administered in a separate study (ACTRN12613000723785). The cartoons are currently being updated through focus groups and consultations with young people and experts to increase their relevancy to students from diverse backgrounds. In particular, the refined OurFutures Mental Health intervention will reflect the experiences and feelings of LGBTQ+ young people, and young people exposed to adverse childhood experiences (i.e., trauma-informed).
Intervention code [1] 324736 0
Prevention
Comparator / control treatment
Control schools will implement health education as usual. All control schools will implement curriculum-based health education during the trial (but will vary in the method of delivery - possible methods include powerpoint presentations, short videos, hard-copy workbooks, group discussions). This group will serve as an ‘active control’. Control school staff will complete a logbook to record the details of health education, including mental health, components delivered during the trial period. Control schools will be offered complimentary use of the intervention at the end of the study in 2024.
Control group
Active

Outcomes
Primary outcome [1] 332945 0
Mental health knowledge.
Trial-specific measure to capture student knowledge of mental health delivered through the intervention. For example, identifying symptoms of anxiety and depression, coping skills such as thought challenging.
Timepoint [1] 332945 0
Assessed at baseline, post-intervention (within 1 week post-intervention), 3-months and 9-months post-baseline. Primary timepoint is 3-months post-baseline.
Primary outcome [2] 332946 0
Anxiety symptoms.
Measured using the GAD-7 (Spitzer et al., 2006).

Spitzer, R.L., et al., A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med, 2006. 166(10): p. 1092-7.
Timepoint [2] 332946 0
Assessed at baseline, post-intervention (within 1 week post-intervention), 3-months and 9-months post-baseline. Primary timepoint is 3-months post-baseline.
Primary outcome [3] 332947 0
Depressive symptoms. Measured using the Patient Health Questionnaire for Adolescents (PHQ-A; Johnson et al., 2002).

Johnson, J.G., et al., The Patient Health Questionnaire for Adolescents: Validation of an instrument for the assessment of mental disorders among adolescent primary care patients. Journal of Adolescent Health, 2002. 30(3): p. 196-204
Timepoint [3] 332947 0
Assessed at baseline, post-intervention (within 1 week post-intervention), 3-months and 9-months post-baseline. Primary timepoint is 3-months post-baseline.
Secondary outcome [1] 415264 0
General well-being.
Measured using the Short Warwick Edinburgh Mental Wellbeing Scale (Clarke et al., 2011).

Clarke, A., Friede, T., Putz, R., Ashdown, J., Martin, S., Blake, A., ... & Stewart-Brown, S. (2011). Warwick-Edinburgh Mental Well-being Scale (WEMWBS): validated for teenage school students in England and Scotland. A mixed-methods assessment. BMC Public Health, 11(1), 487.
Timepoint [1] 415264 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [2] 415265 0
General help-seeking.

Measured by a measure of General Help-seeking created for the trial to assess sources from which students would seek help from should they have a problem.
Timepoint [2] 415265 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [3] 415266 0
Actual help-seeking.
For students who have experienced a personal or emotional problem in the past 6 months, the sources from which they sought help will be measured using the Actual Help-Seeking Questionnaire (AHSQ; Rickwood et al., 2005).

Rickwood, D., Deane, F. P., Wilson, C., & Ciarrochi, J. Young people’s help-seeking for mental health problems. Advances in Mental Health. Advances in Mental Health, 2005. 4(3): Supplement.
Timepoint [3] 415266 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [4] 416528 0
Social, emotional, and behavioural problems.
Measured using the Strengths and Difficulties Questionnaire (SDQ; Goodman et al., 1998).

Goodman, R., Meltzer, H., & Bailey, V. (1998). The strengths and difficulties questionnaire: A pilot study on the validity of the self-report version. European Child & Adolescent Psychiatry, 7(3), 125–130. https://doi.org/10.1007/s007870050057
Timepoint [4] 416528 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [5] 416529 0
Psychological distress. Measured by the Kessler 6.

Reference: K6

Kessler, R.C., et al., Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med, 2002. 32(6): p. 959-76.
Timepoint [5] 416529 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [6] 416530 0
Functional impairment from psychological distress. Two items from the Kessler Psychological Distress Scale (K6+) assessing the number of days in the last month students were either totally unable to carry out their normal activities, or only able to do half or less of what they would normally have been able to do, due to their feelings of psychological distress (Kessler et al., 2002).
Timepoint [6] 416530 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [7] 416531 0
Functional impairment from depressive symptoms. Measured by an additional item to the PHQ-A assessing the extent to which any endorsed depressive symptoms on the PHQ-A have impacted their ability to fulfil their normal responsibilities at school, home, or in social situations.
Timepoint [7] 416531 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [8] 416532 0
Quality of Life. Measured with the Child Health Utility Instrument (CHU-9D)

Reference: Ratcliffe, J., Stevens, K., Flynn, T., Brazier, J. & Sawyer, M. An assessment of the construct validity of the CHU9D in the Australian adolescent general population. Quality of Life Research, 2012. 21: p. 717-725.
Timepoint [8] 416532 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [9] 416533 0
Resource Use. Trial-specific measure assessing number of visits to various healthcare professionals.
Timepoint [9] 416533 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [10] 416883 0
Alcohol use.
Frequency and quantity of alcohol consumption in standard drinks.

Adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index.

Reference: McBride N, Farringdon F, Midford R, et al. Harm Minimization in School Drug Education: Final Results of the School Health and Alcohol Harm Reduction Project (SHAHRP). Addiction. 2004 Mar;99(3):278-91.
Timepoint [10] 416883 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [11] 416884 0
Frequency of binge drinking.

Adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index.

Reference: McBride N, Farringdon F, Midford R, et al. Harm Minimization in School Drug Education: Final Results of the School Health and Alcohol Harm Reduction Project (SHAHRP). Addiction. 2004 Mar;99(3):278-91.
Timepoint [11] 416884 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [12] 416885 0
Maximum number of standard drinks consumed on one occasion.

Adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index.

Reference: McBride N, Farringdon F, Midford R, et al. Harm Minimization in School Drug Education: Final Results of the School Health and Alcohol Harm Reduction Project (SHAHRP). Addiction. 2004 Mar;99(3):278-91.
Timepoint [12] 416885 0
Assessed at baseline, post-intervention, 3-months and 9-months post-baseline.
Secondary outcome [13] 420123 0
Functional impairment from anxiety symptoms. Measured with an additional item to the GAD-7 assessing the extent to which any anxiety symptoms endorsed on the GAD impacted their ability to fulfil their responsibilities at school, home, or in social situations.
Timepoint [13] 420123 0
Assessed at baseline, post-intervention, 3-months post-baseline and 9-months post-baseline.

Eligibility
Key inclusion criteria
Inclusion criteria include i) Year 8 students attending participating schools in 2023; ii) fluent in English; iii) provision of active informed consent; iv) provision of opt-out parental consent.

Trial sites (schools) must:
i) Be a secondary or combined primary and secondary school in NSW, and
ii) Have school principal permission to participate in the trial
Minimum age
11 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include i) schools with <70 Year 8 students.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by central randomisation by computer. Schools will be randomly allocated to groups by an external researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation (school-level) will be used to avoid contamination of the controls by the intervention group through student communication. Following school recruitment, randomisation, stratifying by (binary) sex, will be conducted using the Blockrand function in R. Schools will not be masked to their allocation and will be informed whether they are in the intervention or control group. Participants (i.e. students) will be blinded to the hypotheses of the study. Researchers will be aware of the schools’ allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations
The sample size calculations are based on the method developed by Heo and Leon that can detect an intervention by time interaction in longitudinal cluster RCTs (Heo and Leon, 2009). To detect differences between groups across the four measurement occasions, six schools with an average of 100 students per school will need to be randomly allocated to each group. This will achieve 80% power to detect an effect size of 0.15 (p=.05) in the primary outcome at the trial end. An effect size of 0.15 is in line with similar school-based prevention trials of anxiety and depression and would have substantial benefits on a population level based on economic modelling. To account for school dropouts during the trial, which are expected to be approximately 10% based on similar previous school-based trails, we will aim to recruit a minimum of 14 schools. Based on rates in our previous school-based universal substance use prevention trials we anticipate most, if not all, students will participate. An average of 100 students per school will result in a minimum of 1400 students from 14 schools at baseline to test intervention effects.

Analysis
Baseline equivalence and attrition between groups will be examined using single-level analyses; one-way analyses of variance (normally distributed data), chi-squared analyses (binominal data), and Mann-Whitney U-tests (non-normally distributed data). To examine intervention by time interaction effects, multilevel (generalised) linear mixed effects models will be used due to the multi-level nature of the data (students nested within schools). Hypothesised intervention effects on knowledge, anxiety and depression symptoms will be examined using mixed effects linear regression analysis (normally distributed data) and mixed effects logistic regression analysis (categorical data). Intervention effects on primary outcomes will be examined in the whole sample. Additionally, subgroup analyses will test the intervention effects on primary outcomes among students exhibiting elevated symptoms of depression and anxiety at baseline. The existing sample size (14 schools of an average 100 students each) will achieve 80% power to detect an effect size of 0.3 (p=.05) in primary outcomes at trial end. An effect size of 0.3 is in line with effect sizes found in selective prevention trials of anxiety and depression (i.e., targeting those at high risk of outcomes).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/07/2023
Actual
14/07/2023
Date of last participant enrolment
Anticipated
4/08/2023
Actual
9/05/2024
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
1400
Accrual to date
Final
754
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 312533 0
Charities/Societies/Foundations
Name [1] 312533 0
The Paul Ramsay Foundation
Country [1] 312533 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314137 0
None
Name [1] 314137 0
Address [1] 314137 0
Country [1] 314137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311866 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 311866 0
Ethics committee country [1] 311866 0
Australia
Date submitted for ethics approval [1] 311866 0
22/08/2022
Approval date [1] 311866 0
03/11/2022
Ethics approval number [1] 311866 0
2022/700

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122650 0
Dr Emma Barrett
Address 122650 0
The Matilda Centre for Research in Mental Health and Substance Use, Level 6, Jane Foss Russell Building G02, The University of Sydney NSW 2006
Country 122650 0
Australia
Phone 122650 0
+61 2 86279048
Fax 122650 0
Email 122650 0
[email protected]
Contact person for public queries
Name 122651 0
Lucinda Grummitt
Address 122651 0
The Matilda Centre for Research in Mental Health and Substance Use, Level 6, Jane Foss Russell Building G02, The University of Sydney NSW 2006
Country 122651 0
Australia
Phone 122651 0
+61 2 86279048
Fax 122651 0
Email 122651 0
[email protected]
Contact person for scientific queries
Name 122652 0
Lucinda Grummitt
Address 122652 0
The Matilda Centre for Research in Mental Health and Substance Use, Level 6, Jane Foss Russell Building G02, The University of Sydney NSW 2006
Country 122652 0
Australia
Phone 122652 0
+61 2 86279048
Fax 122652 0
Email 122652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and aggregated at the school level. IPD will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17475Study protocol    The study protocol will be published in an academi... [More Details]



Results publications and other study-related documents

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