Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000876998
Ethics application status
Approved
Date submitted
14/07/2020
Date registered
3/09/2020
Date last updated
3/03/2022
Date data sharing statement initially provided
3/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Building Educators’ Skills in Adolescent Mental Health (BEAM) study: A cluster randomised-controlled trial of an adolescent mental health training program for secondary school Educators
Scientific title
A Cluster-Randomised, Two-Arm Waitlist-Controlled Trial of the Effectiveness of a Web-based Adolescent Mental Health Training Program for Educators in Leadership Roles: The Building Educators’ Skills in Adolescent Mental Health (BEAM) Study.
Secondary ID [1] 301759 0
N/A
Universal Trial Number (UTN)
U1111-1253-3176
Trial acronym
N/A
Linked study record
Record ACTRN12619000821190, is the pilot study of this present study.

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 318224 0
Self-reported confidence in managing student mental health 318225 0

Mental health knowledge
 318226 0
Stigma 318227 0
Helping behaviours 318228 0
Anxiety 318528 0
Depression 318529 0
Condition category
Condition code
Public Health 316235 316235 0 0
Health promotion/education
Mental Health 316236 316236 0 0
Anxiety
Mental Health 316237 316237 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being evaluated in this study is the BEAM training program. BEAM is an online program designed for secondary school educators in leadership roles, to educate them about adolescent mental health. The program was originally designed in collaboration with an Advisory Group consisting of secondary school Year Advisors from across New South Wales (NSW), Australia, and aims to provide educators with the knowledge and skills they require to best support their students’ mental health needs. BEAM is based on a theory of change. which proposes an improvement in knowledge leads to an improvement in attitude and confidence in performing helping behaviours towards others. By improving educators’ knowledge of adolescent mental health, BEAM aims to build their confidence in supporting and responding to students experiencing mental health problems and increase their frequency of engaging in actual helping behaviours. It is also anticipated that through an increase in confidence, participants will report a reduction in their own psychological distress

BEAM utilises a blended-style of delivery incorporating both online and face-to-face components. The online content consists of 5 training modules, each containing 3-5 lessons, information, case studies, quizzes, and blog-style story sharing. In addition to the online content, peer-coaching activities encourage participants to meet with their school colleagues and discuss focus questions to help consolidate what has been learned and to apply the information to their own unique situation. Given the current physical distancing guidelines and possible school closures due to physical distancing policies, this component is being adapted to encourage phone calls or online meetings (via teleconference software such as Zoom, Microsoft Teams, and Skype) to complete these activities. These additional peer-coaching activities are optional and there is no restriction on the pace at which users complete the learning modules. The approximate timings for each module, including the content lessons and activity lessons are as follows: Module 1 - 42 minutes; Module 2 - 57 minutes; Module 3 - 52 minutes; Module 4 - 42 minutes; Module 5 - 48 minutes. It is anticipated each peer-coaching activity will take approximately 30 minutes each to discuss the content and enter responses. Therefore, in total, it is estimated that the full training program will take approximately 6.5 hours to complete, and it’s recommended that participants complete one module per fortnight to provide time to complete their peer activities and consolidate their learning. The program can be completed in any order and one module is recommended to participants as a starting point, based on their answers during baseline. All participants will have access to the program for a period of 10 weeks, which can be completed on any computer, laptop, smartphone, or portable tablet device, accessed via a website.

Program usage will be measured by the number of lessons and activities completed, which is recorded automatically by the online platform hosting the program.
Intervention code [1] 318058 0
Behaviour
Comparator / control treatment
Waitlist control. The control group will receive the intervention upon completion of the 22-week follow-up survey,
Control group
Active

Outcomes
Primary outcome [1] 324425 0
Change in self-reported confidence in recognising and managing student mental health needs, assessed using an adapted version of the Confidence to Recognise, Refer, and Support sub-scale from Sebbens, Hassmén, Crisp, and Wensley (2016).
Timepoint [1] 324425 0
10 weeks after baseline
Secondary outcome [1] 384598 0
Change in self-reported confidence in recognising and managing student mental health needs, assessed using an adapted version of the Confidence to Recognise, Refer, and Support sub-scale from Sebbens, Hassmén, Crisp, and Wensley (2016).
Timepoint [1] 384598 0
22 weeks after baseline
Secondary outcome [2] 384599 0
Change in perceived mental health knowledge, assessed using the Perceived Mental Health Knowledge sub-scale from the Mental Health Literacy and Capacity Survey for Educators (Fortier, Lalonde, Venesoen, Legwegoh, and Short,2017).
Timepoint [2] 384599 0
10 and 22 weeks after baseline
Secondary outcome [3] 384600 0
Change in perceived mental health awareness, assessed using the Perceived Mental Health Awareness sub-scale from the Mental Health Literacy and Capacity Survey for Educators (Fortier, Lalonde, Venesoen, Legwegoh, and Short, 2017).
Timepoint [3] 384600 0
10 and 22 weeks after baseline
Secondary outcome [4] 384601 0
Change in mental health knowledge, assessed using an adapted version of the Mental Health Knowledge Schedule (MAKS; Evans-Lacko et al., 2010)
Timepoint [4] 384601 0
10 and 22 weeks after baseline
Secondary outcome [5] 384602 0
Change in stigma, assessed using a modified version of the Perceived Stigma sub-scale from the Depression Stigma Scale (Griffiths, Christensen, Jorm, Evans, & Groves, 2004).
Timepoint [5] 384602 0
10 and 22 weeks after baseline
Secondary outcome [6] 384603 0
Change in frequency of helping behaviours engaged in, assessed using an adapted version of the Helping Provided to Students sub-scale used in Jorm, Kitchener, Sawyer, Scales, and Cvetkovski (2010).
Timepoint [6] 384603 0
10 and 22 weeks after baseline
Secondary outcome [7] 384604 0
Change in level of personal psychological distress, assessed using the Distress Questionnaire 5 (DQ-5; Batterham et al., 2016).
Timepoint [7] 384604 0
10 and 22 weeks after baseline
Secondary outcome [8] 385362 0
Change in mental health recognition, assessed using an adapted version of the Recognition of Mental Illness vignettes from Jorm and Wright (2008).
Timepoint [8] 385362 0
10 and 22 weeks after baseline

Eligibility
Key inclusion criteria
Educators eligible for the trial must meet the following conditions in randomised schools:
1. Are currently employed in a school leadership position that includes responsibility for student wellbeing in addition to their regular teaching duties. Such roles include Year Advisors, Directors (or Heads) of Student Wellbeing, Deputy Principals, Directors of Pastoral Care, Student Coordinators, and Heads of Year
2. Are currently working in this role at a government, Catholic, or independent secondary school (from Years 7 to 12) in NSW, Australia
3. Are working at their school for the duration of the study (maximum 32 weeks)
4. Are working at a school at which the principal has agreed to participation in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participation in the pilot trial of BEAM in 2019.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The holder of the allocation schedule was off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at the school level will be used to avoid contamination effects from other participants. Schools will be randomised with a 1:1 allocation stratified by school size (<400 or >400 students) and Index of Community Socio-Educational Advantage (ICSEA) level (<1000 or >1000) as per a computer-generated randomisation schedule. The permuted block randomisation will be used but not disclosed to ensure concealment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
The target sample size is 234 participants from approximately 50 schools. This is conservatively based on the participation of an average of five educators per school and an intra-class correlation (ICC) of .07 which yields a design effect of 1.28. To detect a medium effect size (d) of .5, with power at 0.8, and alpha of 0.05 (two-tailed) in an unclustered trial would require 64 participants per arm. This number is inflated by the design effect to 82 to allow for clustering, with the recruitment increased to allow for attrition of up to 30%. This yields 117 participants per arm.

Analyses
The intervention arm (receive the intervention program immediately) will be compared to the waitlist control arm (receive the intervention program after completion of the follow-up survey) for the all analyses.

Analyses of the primary outcome will be undertaken using planned contrasts comparing a change in self-reported confidence from baseline to post intervention between the trial arms (BEAM vs. waitlist control). The primary analysis will use a mixed model repeated measures analysis of variance (MMRM), accounting for repeated assessments within individuals and a random effect to account for clustering within schools. Models will include time, condition (intervention vs control) and their interaction, with the critical test of efficacy based on this interaction term indicating differential change over time. MMRM constitutes an intention-to-treat analysis, as it accounts for all available data under the missing-at-random assumption. Transformation of scores, including categorisation, may be undertaken to meet distributional assumptions and accommodate outliers. Where distributional assumptions cannot be satisfied, bootstrapping methods may be used to confirm the robustness of normal theory results. All outcomes will be treated as continuous variables, although binary MMRM will be used where there are fewer than six data points for an outcome. Between-group effect sizes will be estimated based on raw estimates of mean (SD).

Secondary and additional outcome analyses will involve contrasts comparing change on secondary outcomes (mental health knowledge, stigma, helping behaviours, and psychological distress) from baseline to other occasions of measurement, using an MMRM approach, as described above.

If the intervention is found to be effective, supplementary analyses will examine evidence for moderation or mediation effects, i.e., whether the intervention was more effective for certain subgroups of the sample. These analyses will repeat the MMRM approach but with the inclusion of interaction effects for mediators/moderators.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/08/2020
Date of last participant enrolment
Anticipated
22/02/2021
Actual
29/09/2020
Date of last data collection
Anticipated
25/07/2021
Actual
17/03/2021
Sample size
Target
234
Accrual to date
Final
295
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305401 0
Charities/Societies/Foundations
Name [1] 305401 0
Balnaves Foundation
Country [1] 305401 0
Australia
Funding source category [2] 306199 0
Charities/Societies/Foundations
Name [2] 306199 0
CommBank Foundation
Country [2] 306199 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW, Sydney, NSW, Australia, 2052
Country
Australia
Secondary sponsor category [1] 306671 0
None
Name [1] 306671 0
Address [1] 306671 0
Country [1] 306671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305724 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 305724 0
Ethics committee country [1] 305724 0
Australia
Date submitted for ethics approval [1] 305724 0
06/04/2020
Approval date [1] 305724 0
21/04/2020
Ethics approval number [1] 305724 0
HC200257
Ethics committee name [2] 306409 0
Catholic Education Office Diocese of Maitland-Newcastle
Ethics committee address [2] 306409 0
Ethics committee country [2] 306409 0
Australia
Date submitted for ethics approval [2] 306409 0
25/05/2020
Approval date [2] 306409 0
27/05/2020
Ethics approval number [2] 306409 0
N/A
Ethics committee name [3] 306410 0
NSW Education Department State Education Research Applications Process (SERAP)
Ethics committee address [3] 306410 0
Ethics committee country [3] 306410 0
Australia
Date submitted for ethics approval [3] 306410 0
11/06/2020
Approval date [3] 306410 0
21/07/2020
Ethics approval number [3] 306410 0
SERAP2020200
Ethics committee name [4] 306411 0
Catholic Education Office Diocese of Canberra-Goulburn
Ethics committee address [4] 306411 0
Ethics committee country [4] 306411 0
Australia
Date submitted for ethics approval [4] 306411 0
10/06/2020
Approval date [4] 306411 0
12/06/2020
Ethics approval number [4] 306411 0
N/A
Ethics committee name [5] 306595 0
Catholic Education Office Diocese of Wollongong
Ethics committee address [5] 306595 0
Ethics committee country [5] 306595 0
Australia
Date submitted for ethics approval [5] 306595 0
15/06/2020
Approval date [5] 306595 0
04/08/2020
Ethics approval number [5] 306595 0
N/A

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

Contacts
Principal investigator
Name 101362 0
Dr Belinda Parker
Address 101362 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 101362 0
Australia
Phone 101362 0
+61 2 9065 9057
Fax 101362 0
Email 101362 0
[email protected]
Contact person for public queries
Name 101363 0
Belinda Parker
Address 101363 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 101363 0
Australia
Phone 101363 0
+61 2 9065 9057
Fax 101363 0
Email 101363 0
[email protected]
Contact person for scientific queries
Name 101364 0
Belinda Parker
Address 101364 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 101364 0
Australia
Phone 101364 0
+61 2 9382 9271
Fax 101364 0
Email 101364 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
This will not be available as per the conditions of our ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8496Ethical approval    379576-(Uploaded-07-08-2020-12-12-13)-Study-related document.pdf
8499Informed consent form    379576-(Uploaded-07-08-2020-12-12-58)-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.