Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000910606
Ethics application status
Approved
Date submitted
10/08/2023
Date registered
24/08/2023
Date last updated
24/08/2023
Date data sharing statement initially provided
24/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of a mental health literacy program in primary schools
Scientific title
A pragmatic controlled trial examining the impact of a mental health literacy program in primary schools on knowledge, help-seeking, and stigma.
Secondary ID [1] 309144 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 329245 0
anxiety 329246 0
Condition category
Condition code
Mental Health 326203 326203 0 0
Anxiety
Mental Health 326204 326204 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Thriving Minds intervention consists of two classroom sessions that are delivered by a lived experience educator. There are 2 x 50 minute sessions held one week apart. The program aims to address mental health literacy and stigma by normalising uncomfortable emotional experiences, equip students with effective self-care strategies, and encourage them to seek help for emotional problems. Content is mapped to the Australian curriculum and delivered with classroom teachers present, who are ideally placed to support ongoing classroom use of emotion literacy content. The program focuses on key concerns for 8–10-year-olds, including coping with stress/anxiety and responding to bullying. The content is delivered through developmentally appropriate story books and classroom discussions.

Adherence to the intention will be monitored via a fidelity checklist completed by facilators following each session.

Allocation to the trial conditions (intervention or wait-list control) will be pragmatic, by school, based on school timetable availability. The school’s choice of program timing will determine their allocation to intervention or control.
Intervention code [1] 325593 0
Prevention
Comparator / control treatment
Wait-list control (usual classes).
The waitlist control group will receive the Thriving Minds program at the conclusion of the trial (after the 12 week follow up).
Control group
Active

Outcomes
Primary outcome [1] 334599 0
Help-seeking intentions
7 item scale adapted from the General Help Seeking Questionnaire [GHSQ] (Jorm et al., 1997)
Timepoint [1] 334599 0
Pre-intervention, post-intervention (primary timepoint, 1 week after completion of the Thriving Minds intervention) and 12-week follow-up.
Secondary outcome [1] 421357 0
Help-seeking knowledge
Free-text item adapted from the GHSQ (Wilson et al., 2005).
Timepoint [1] 421357 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [2] 425223 0
Help-seeking confidence
Single confidence in help-seeking item adapted from (Calear et al., 2021).
Timepoint [2] 425223 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [3] 425297 0
Help-seeking attitudes
12 item helpfulness scale adapted from Christensen et al., 2004
Timepoint [3] 425297 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [4] 425298 0
Actual self-help behaviour
5 item scale adapted from the Actual Help-Seeking Questionnaire (Rickwood & Braithwaite, 1994).
Timepoint [4] 425298 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [5] 425299 0
Emotion vocabulary
Free text response adapted from prior research (Francis et al., 2020; Greenberg et al., 1995).
Timepoint [5] 425299 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [6] 425300 0
Emotion recogntion
Bespoke 12-response emotion identification checklist
Timepoint [6] 425300 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [7] 425301 0
Physiological components of emotion
Bespoke 13-item physiological components of emotion recognition checklist
Timepoint [7] 425301 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [8] 425323 0
Bodily awareness of emotions
5-item Bodily Awareness subscale of the Emotion Awareness Questionnaire [EAQ] (Rieffe et al., 2007).
Timepoint [8] 425323 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [9] 425324 0
Emotion attitudes
5-item Not Hiding Emotions subscale of the Emotion Awareness Questionnaire [EAQ] (Rieffe et al., 2007).
Timepoint [9] 425324 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [10] 425325 0
Stigma attributions
6-item vignette rating scale adapted from the Revised Attribution Questionnaire [r-AQ] (Corrigan et al., 2007; Watson et al., 2004)
Timepoint [10] 425325 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [11] 425335 0
Stigma associations
15-item measure adapted from The Stigma of Suicide Scale (Batterham et al., 2013).
Timepoint [11] 425335 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [12] 425336 0
Trusted adults at school
4-item measure adapted from the Trusted adults at school scale (Pisani et al., 2013), used in the Sources of Strength trials (Calear et al., 2016) (Wyman et al., 2010).
Timepoint [12] 425336 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [13] 425337 0
Peer integration at school
4-item measure adapted from the peer integration at school scale, used in the Sources of Strength trials (Calear et al., 2016) (Wyman et al., 2010),
Timepoint [13] 425337 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [14] 425338 0
Adapted Stirling Children’s Wellbeing Scale (Liddle & Carter, 2015)
Timepoint [14] 425338 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.
Secondary outcome [15] 425339 0
Bespoke rating measure and open-ended questions for children regarding acceptability and satisfaction with program
Timepoint [15] 425339 0
Post-completion of Thriving Minds intervention and 12-week follow-up.
Secondary outcome [16] 425340 0
Bespoke rating measure and open-ended questions regarding for teachers regarding perceived value, intention to use, and actual use, of program content.
Timepoint [16] 425340 0
post-completion of Thriving Minds intervention and 12-week follow-up.
Secondary outcome [17] 425341 0
To explore the impact, strengths, and areas for improvement of the program, semi-structured qualitative interviews with school staff using a study-specific question protocol will be conducted by members of the research team. Interviews will be up to 1 hour and will be audio-recorded and transcribed for coding.
Members of the research team will also conduct semi-structured qualitative focus groups with 4-5 children using a study-specific question protocol. Children will be randomly invited based on those with existing parental consent to take part in further research. Groups will be conducted once 4-6 children have consented. Focus group interviews will be up to 1 hour, and the maximum number of children participating will be 50 children.
Timepoint [17] 425341 0
12-week follow-up.
Secondary outcome [18] 425667 0
Actual help-seeking behaviour
7 item scale adapted from the Actual Help-Seeking Questionnaire (Rickwood & Braithwaite, 1994).
Timepoint [18] 425667 0
Pre-intervention, post-completion of Thriving Minds intervention, and 12-week follow-up.

Eligibility
Key inclusion criteria
The current project is a universal trial, meaning all students within a participating classroom will be invited to participate in the trial. As such, all students in years 3 or 4 who are in a classroom that will be taking part in the Thriving Minds program who can complete a survey, independently or with usual classroom supports, can participate in the study.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria; however, participants must meet the inclusion criteria and provide consent and parental consent.


Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previous primary school RCT of a mental illness stigma intervention [Link et al., 2020], we anticipate an effect size of d=0.35 in literacy and stigma. Based on typical session sizes of n=40-50 students per school, recruiting 12 schools (6 intervention/6 control; N=500) will provide >83% power to detect an effect, assuming up to 20% attrition and accounting for clustering with an intraclass correlation of 0.03.

Analyses of continuous measures will be undertaken on an intent-to-treat basis, including all participants consenting, regardless of treatment actually received or withdrawal from the study. Mixed-model repeated measures (MMRM) analyses will be used because of the ability of this approach to include participants with missing data without using biased techniques, such as last observation carried forward. In addition, by incorporating appropriate random effects for each school, MMRM can accommodate and assess the strength and significance of clustering effects. MMRM is the standard and most robust methodology for analysing longitudinal trials [Lane, 2008; Siddiqui, 2011). Analysis of binary outcomes will be undertaken using binary mixed models, analogous to linear MMRM.

Qualitative analysis of the semi-structured interviews will be conducted using Framework
Analysis. Framework Analysis was designed for addressing social policy research questions (Ritchie & Spencer, 1994) and has been used frequently in health research (Gale et al., 2013). It follows a systematic process of inductive coding, generating a table of findings across participants that is conducive to interpretation and input from multiple researchers.

Gale, N.K., et al. (2013). Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Medical Research Methodology, 13, 117.
Link, B.G., et al. (2020). A school-based intervention for mental illness stigma: A cluster randomized trial. Pediatrics, 145, e20190780.
Lane, P. (2008). Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches. Pharmaceutical Statistics, 7, 93-106.
Ritchie, J. & Spencer, L. (1994). Qualitative data analysis for applied policy research, in Analyzing Qualitative Data, A. Bryman and R. Burgess, Editors. Routledge: London, UK.
Siddiqui, O. (2011). MMRM versus MI in dealing with missing data—A comparison based on 25 NDA data sets. Journal of Biopharmaceutical Statistics, 21, 423-436.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/07/2023
Date of last participant enrolment
Anticipated
24/06/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
500
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 313345 0
Charities/Societies/Foundations
Name [1] 313345 0
Australian Rotary Health Fund
Country [1] 313345 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Centre for Mental Health Research
63 Eggleston Rd
The Australian National University
Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 315093 0
None
Name [1] 315093 0
Address [1] 315093 0
Country [1] 315093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312567 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 312567 0
Ethics committee country [1] 312567 0
Australia
Date submitted for ethics approval [1] 312567 0
10/04/2023
Approval date [1] 312567 0
16/05/2023
Ethics approval number [1] 312567 0
2023/192

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

Contacts
Principal investigator
Name 125118 0
Prof Alison L. Calear
Address 125118 0
Centre for Mental Health Research
63 Eggleston Rd
The Australian National University
Acton, 2601, ACT
Australia
Country 125118 0
Australia
Phone 125118 0
+61 2 6125 8406
Fax 125118 0
Email 125118 0
[email protected]
Contact person for public queries
Name 125119 0
Alison L. Calear
Address 125119 0
63 Eggleston Rd
The Australian National University
Acton, 2601, ACT
Australia
Country 125119 0
Australia
Phone 125119 0
+61 2 6125 8406
Fax 125119 0
Email 125119 0
[email protected]
Contact person for scientific queries
Name 125120 0
Alison L. Calear
Address 125120 0
Centre for Mental Health Research
63 Eggleston Rd
The Australian National University
Acton, 2601, ACT
Australia
Country 125120 0
Australia
Phone 125120 0
+61 2 6125 8406
Fax 125120 0
Email 125120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We do not intend to make the line by line data public. However, deidentified data will be shared upon reasonable request to the Principal Investigator. Data shared will be limited to individual participant data of primary and secondary outcomes, and general demographic information that would not lead to identification of students (e.g., age, school type: government, parochial, private).
When will data be available (start and end dates)?
Requests for data may be considered by the Principal Investigator after the publication of the main results. Data will be archived for future use with no end date specified.
Available to whom?
Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator.
Available for what types of analyses?
Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator.
How or where can data be obtained?
Access to data will be subject to approval by Principal Investigator (Prof Alison Calear, contact email:[email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.