Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001126909
Ethics application status
Approved
Date submitted
13/07/2020
Date registered
30/10/2020
Date last updated
23/08/2022
Date data sharing statement initially provided
30/10/2020
Date results information initially provided
23/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting Teacher Mental Health: A School-based Risk Management and Health Promotion Intervention for Teachers
Scientific title
A Pragmatic Cluster Randomised Controlled Trial to Evaluate the Effect of a Scalable Approach to Risk Management and Health Promotion on Psychological Distress and Psychosocial Safety Climate in School Teachers.
Secondary ID [1] 301023 0
Nil known
Universal Trial Number (UTN)
U1111-1254-1454
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 317075 0
Psychosocial safety climate 317646 0
Condition category
Condition code
Mental Health 315241 315241 0 0
Other mental health disorders
Public Health 315242 315242 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pragmatic design will be used for a randomised controlled trial (RCT) in which clusters (i.e., schools) are randomly assigned to receive the intervention in year 2021 or 2022. Although the larger project comprises a total of four intakes, only schools allocated in the first and third intakes constitute the RCT of interest in this application. Schools allocated to the intervention condition (i.e. Intake 1 schools) will receive the intervention described below in Terms 1-2 in 2021.

The intervention approach and content is based on the principles of risk management and well-being promotion to proactively address health, safety and wellbeing in the workplace, as well as the PERMA (Positive Emotion, Engagement, Relationships, Meaning, Achievement) theory of well-being (from the work of Dr Martin Seligman). The intervention consists of two key components, with one component targeted at the school (organisational) level, and one targeted at the teacher (individual) level. First, well-being ‘coaches’ will guide school leaders and health and safety representatives to understand the intervention approach, identify gaps in their mental health provisions and health promotion activities, and assist them in developing a mental well-being action plan for school staff. School leaders will also receive a brief eLearning program on psychological health and safety via a digital platform (the FlourishDx app). Second, teachers will receive access to a brief eLearning program on mental health awareness and positive psychology via the FlourishDx app. While teachers and school leaders would have access to the eLearning program and other features on the app up till 31 December 2022, the active intervention where contact with key school personnel in the form of reviews and consultations is for 6 months (2 school terms).

At the school level (first component of the intervention), the school leadership team at each school will first receive a 1.5-hour virtual briefing on the intervention approach and support in identifying gaps in their mental health provisions and health promotion activities. School leaders will then be invited to complete an eLearning program on psychological health and safety on the FlourishDx app at their own pace within a two-week period. Further, their school's health and safety representatives and/or well-being champions will receive one half-day virtual workshop aimed to equip school personnel with knowledge and skills to better understand key risks and identify improvement strategies at their workplaces, and to develop a mental well-being action plan. The workshop may either be at individual participating schools, or several groups of schools together. Subsequently, each school’s project implementation is supported by phone consultations and other asynchronous communication. All briefings and consultations will be conducted by well-being coaches with extensive experience in applying positive psychology in education. Adherence to intervention, including attendance at consultations/workshops and eLearning program completion will be assessed and monitored by attendance lists and app analytics.

At the teacher level (second component of intervention), participating teachers will receive access to an eLearning program via the FlourishDx app and are encouraged to complete the 1.5-hour eLearning program in a self-paced format within a two-week timeframe during the intervention period for their school. Topics covered in the eLearning program include anxiety, depression, resilience, relaxation, diet, sleep, exercise, positive emotions, positive relationships, meaningfulness and accomplishments. Components of this eLearning program include a series of animated 2-5 minute videos and breathing exercises and short quizzes. Further, the FlourishDx app includes optional surveys for assessing one's wellbeing, character strengths and work design, with immediate feedback for self-monitoring. These surveys are designed to be part of the intervention. The app has also a “mental fitness coach bot” that identifies user needs (based on survey results) and interests, and then sends notifications to users to encourage specific practices tailored to the individual in a conversational manner. All topics in the eLearning program and optional features are available on the app from the commencement of the intervention period for their school to 31 December 2022. Teachers can choose how to engage with the content and features on the app. Adherence to intervention and intervention engagement will be assessed by app analytics.
Intervention code [1] 317695 0
Behaviour
Comparator / control treatment
Schools allocated to the wait-list control group (i.e. Intake 3 schools) will receive the intervention one year after the intervention group (also one year post-baseline assessment) in Terms 1-2 2022. During the waiting period, teachers of wait-listed schools will have access to the FlourishDx app to complete the assessment surveys and other optional wellbeing surveys. In addition, school leaders' access to the online knowledge sharing portal will be delayed until the 12-month assessment (t2) has been completed. The eLearning programs for teachers and school leaders will not be accessible on the app and no consultations will be conducted by the coaches during the waiting period.

Intakes 2 and 4 serve as a small control for Intakes 1 and 3 by completing some of the same measures, but receiving the intervention in a different time of a typical school year (i.e. Terms 3-4) compared to Intakes 1 and 3 (i.e. Terms 1-2). Some data from Intakes 2 and 4 will be used to run subsidiary analyses, such as to assess for possible season or school calendar related variation, or other events (e.g. pandemic changes).
Control group
Active

Outcomes
Primary outcome [1] 323965 0
Change in psychosocial safety climate, as measured by the total score on the Psychosocial Safety Climate (PSC- 12) scale.
Timepoint [1] 323965 0
Data will be collected from teachers at baseline (t1), 12 months (t2 - primary endpoint), and 16 months (t3 - only Intake 1 schools) after baseline.
Primary outcome [2] 323966 0
Change in psychological distress, measured by the total score on the Kessler Psychological Distress Scale (K6).
Timepoint [2] 323966 0
Data will be collected from teachers at baseline (t1), 12 months (t2- primary endpoint), and 16 months (t3 - only Intake 1 schools) after baseline.
Secondary outcome [1] 383450 0
Change in job satisfaction, as measured by the composite score formed by two scales: Job Satisfaction with Work Environment and Job Satisfaction with Profession from the Organisation for Economic Co-operation and Development (OECD) Teaching and Learning International Survey (TALIS) 2018 Teacher Questionnaire.
Timepoint [1] 383450 0
Data will be collected from teachers at baseline (t1), 12 months (t2 - primary endpoint), and 16 months (t3 - only Intake 1 schools) after baseline.
Secondary outcome [2] 383451 0
Change in functional impairment, as measured by two items on the K6 regarding the number of days out of the past 30 days that (1) one is unable to work due to feelings of distress, (2) their productivity was at least halved because of the feelings.
Timepoint [2] 383451 0
Data will be collected from teachers at baseline (t1), 12 months (t2- primary endpoint), and 16 months (t3 - only Intake 1 schools) after baseline.
Secondary outcome [3] 383452 0
Change in intention to quit, as measured by a single-item asking about intention to quit within the next year.
Timepoint [3] 383452 0
Data will be collected from teachers at baseline (t1), 12 months (t2- primary endpoint), and 16 months (t3 - only Intake 1 schools) after baseline.
Secondary outcome [4] 383453 0
Change in WorkCover claims, measured by the number of mental health related compensation claims made.
Timepoint [4] 383453 0
Data will be collected from teachers at baseline (t1), 12 months (t2- primary endpoint), and 16 months (t3 - only Intake 1 schools) after baseline.
Secondary outcome [5] 383454 0
Intervention engagement, as measured by app analytics, including (1) percentage of the eLearning course completed, (2) number of times the built-in well-being check-in surveys were completed, (3) total time spent on the app between baseline and 12-month follow-up.
Timepoint [5] 383454 0
Data will be retrieved from the logs of the database hosting the app accessed by teachers and line managers over the project term. This is assessed at 1 month after intervention commencement, and at the 12-month follow-up.
Secondary outcome [6] 383455 0
Implementation data will be collected using mixed methods, such as surveys, checklists, logs, consultation records, interviews and focus groups.
Timepoint [6] 383455 0
Data will be collected from the coaches, observers of the consultations/workshops for schools, teachers, school leaders and health and safety representatives during and after the intervention phase. Data from logs, checklists and consultation records are assessed at the end of the 6-month intervention period, and at the 12-month follow-up (t2). Data from interviews and focus groups will be assessed after t2.
Secondary outcome [7] 384558 0
Change in absenteeism, as measured by the number of work days missed due to sickness in the past 6 months.
Timepoint [7] 384558 0
Individual level data will be collected from teachers through a question designed specifically for this study at baseline (t1), 12 months (t2), and 16 months (t3 - only Intake 1 schools) after baseline.

Eligibility
Key inclusion criteria
To be eligible for the study, the school must:
1. Be providing primary and/or secondary education in the Independent or Catholic education sectors in Victoria, Australia, AND
2. Commit to engaging in the intervention across the 3 levels (school leadership, health and safety representatives and teachers), AND
3. Participate in the evaluation component of the study (e.g., surveys).

Additionally, teachers who would like to participate in the study must:
1. Be teaching in the participating school, as it is expected that teachers be given protected school time to participate in the various components of the study, AND
2. Be willing to participate in the evaluation component of the study (e.g. surveys).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Teachers who do not teach in the participating school, and do not have regular access to a smart phone or a computer will not be eligible to participate in the study.

School personnel who are not in any of the 3 participant groups identified above (e.g., non-teaching administration staff) will be excluded from the evaluation, although they will be provided with the eLearning course in the app if they are interested.

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)
The allocation of schools into the intervention and wait-list control conditions will be made known only to the school leadership team and health and safety representatives after the completion of baseline assessment. As such, teachers are assumed to be blinded to the allocation assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated by an independent researcher (not part of this study) using a software (https://www.randomizer.org/).
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
Schools and teachers receiving the treatment/s and the people administering the treatment/s cannot be masked due to the nature of the multi-component intervention.

This trial is part of a larger study that aims to promote teacher mental health. For the trial, we aim to recruit and randomise an total sample of 2400 teachers from 60 schools using a 1:1 allocation ratio. Prior to participant enrolment, expression of interest will be collated from schools from August to November 2020. If the response from schools indicate that an equal allocation ratio is not feasible (e.g. due to majority of schools indicating a strong preference for either condition), we will adjust and update our recruitment targets and allocation ratio before baseline data collection commences.

As this is a pragmatic trial, schools randomly allocated to the wait-list control group are allowed to request for the intervention will be provided to them at any time post-randomisation. Should this happen, the school and their teachers will be treated as having withdrawn or drop-out of the study. Our planned period of assessment is up to 17 months post baseline (for Intake 1 schools only).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on available literature, as a workplace preventive intervention, the effect size of the intervention is anticipated to be small-to-medium (Cohen's d=0.2-0.3). With an ICC and alpha of 0.05 and allowing up to 25% attrition among teachers, 30 schools with an average of 40 teachers each would provide > 80% power to detect a significant group difference in change in each of the three primary outcomes between baseline and post-intervention. As such, we aim to recruit and randomise an initial total sample of 2400 teachers from approximately 60 schools, using an equal allocation ratio. If the response to expression of interest from schools indicate that an equal allocation scheme is not feasible (e.g. due to low response rate or having a majority of schools indicating a strong preference for either condition), we will adjust and update our recruitment targets and allocation ratio before randomisation is conducted (e.g. before December 2020).

Analyses will be undertaken on an intention-to-treat (ITT) basis, including data of all teacher participants who completed the baseline assessment. Continuous and categorical measures of outcomes will be examined using marginal or mixed models as appropriate. Where necessary, transformations of raw data will be undertaken to meet distributional assumptions and to accommodate outlying observations. The potential effects of covariates (e.g. school type) and confounders (e.g. any known deviations from protocol) will be modelled in the primary analyses.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/11/2020
Actual
25/01/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/06/2021
Date of last data collection
Anticipated
31/10/2022
Actual
Sample size
Target
2400
Accrual to date
Final
480
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305467 0
Government body
Name [1] 305467 0
WorkWell Improvement Fund (WorkSafe Victoria)
Country [1] 305467 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Innovation Walk
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 306343 0
None
Name [1] 306343 0
Address [1] 306343 0
Country [1] 306343 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305784 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 305784 0
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 305784 0
Australia
Date submitted for ethics approval [1] 305784 0
08/04/2020
Approval date [1] 305784 0
01/06/2020
Ethics approval number [1] 305784 0
23907

Summary
Brief summary
This application is for the purpose of registering a pragmatic cluster-randomised controlled trial that aims to evaluate the efficacy and implementation of a school-based risk management and health promotion intervention for school teachers. Various components of this intervention have been implemented in other non-education industries; this is the first attempt at evaluating the intervention effects and implementation outcomes in the education sector. Participating schools will be randomised into the intervention or wait-list control condition. The intervention consists of a workshop and consultations with school personnel, access to a eLearning program on an app and support from coaches to develop a mental well-being action plan for school staff. Key outcomes include improvements in psychological distress, psychosocial safety climate, as well as reductions in functional impairment, absenteeism, intention to quit and mental health related WorkCover claims.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101582 0
A/Prof Marie Yap
Address 101582 0
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Country 101582 0
Australia
Phone 101582 0
+61 3 9905 0723
Fax 101582 0
Email 101582 0
[email protected]
Contact person for public queries
Name 101583 0
A/Prof Marie Yap
Address 101583 0
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Country 101583 0
Australia
Phone 101583 0
+61 3 9905 0723
Fax 101583 0
Email 101583 0
[email protected]
Contact person for scientific queries
Name 101584 0
A/Prof Marie Yap
Address 101584 0
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Country 101584 0
Australia
Phone 101584 0
+61 3 9905 0723
Fax 101584 0
Email 101584 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. Results arising from this trial may be published in articles or organisation reports; however no individual data will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8126Ethical approval    MUHREC approval certificate 379631-(Uploaded-08-06-2020-12-57-35)-Study-related document.pdf



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.