Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000821190
Ethics application status
Approved
Date submitted
3/05/2019
Date registered
6/06/2019
Date last updated
8/03/2022
Date data sharing statement initially provided
6/06/2019
Date results provided
27/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Building Educators' skills in Adolescent Mental health (BEAM) program: Evaluating a mental health training program for secondary school Year Advisors
Scientific title
The BEAM program: Evaluating the acceptability, feasibility, and preliminary effectiveness of a mental health training program for secondary school Year Advisors
Secondary ID [1] 298148 0
None
Universal Trial Number (UTN)
U1111-1232-7680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 312693 0
Anxiety 312694 0
Condition category
Condition code
Mental Health 311194 311194 0 0
Anxiety
Public Health 311195 311195 0 0
Health promotion/education
Mental Health 311602 311602 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being tested in this study is the BEAM online training program. It was designed in collaboration with high school Year Advisors. The aim of the program is to provide Year Advisors with the knowledge and skills they need to better support students’ mental health. The program is based on a theory of change which proposes that an improvement in knowledge leads to an improvement in attitudes and confidence towards performing helping behaviours. BEAM is the first program we are aware of to apply this model to the unique training needs of Year Advisors, with the goal of improving their mental health knowledge, attitudes, confidence, and helping behaviours towards students. It is also anticipated that through an increase in knowledge and confidence, users will report a reduction in their own psychological distress. The online program utilises a blended style of delivery with users completing 5 online learning topics containing information, case studies, and quizzes. An additional 5 activities delivered through peer-learning requires users to meet with their school colleagues and discuss focus questions. As such, a minimum of two Year Advisors from each school will be recruited in order for users to have at least one colleague at their same professional level to complete these tasks with. The program was developed as an online computer based training to maintain fidelity across users. Program adherence will be measured as time taken to complete learning modules and activities. This is recorded by the online platform hosting the program. Year Advisors will have access to the program for a period of 6 weeks. There is no restriction on the pace at which users complete the learning modules during this time. In total, it is estimated that the training program would take approximately 6.5 hours to complete, however users are encouraged to work through the program in weekly sittings to provide time to complete their peer activities and consolidate their learning. It is anticipated that the online learning content for each topic should take approximately 1 hour to complete with an additional 15-20 minutes allocated for peer-learning.
Intervention code [1] 314371 0
Other interventions
Comparator / control treatment
Uncontrolled trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319952 0
Mental heath knowledge: This will be measured by a change in total scores on an adapted version of the Mental Health Knowledge Scale (MAKS; Evans-Lacko et al., 2010), and Recognition of Mental Illness vignettes (Jorm & Wright, 2008).
Timepoint [1] 319952 0
Timepoint 1: Baseline pre-training (day 1)
Timepoint 2: Post-training (day 43)
Timepoint 3: 3 month follow-up (day 141)
Primary outcome [2] 319953 0
Attitudes: This will be measured by a change in total scores on an adapted version of the Stigmatising Attitudes Scale (Griffiths, K. M., Christensen, H., Jorm, A. F., Evans, K., & Groves, C. , 2004).

Timepoint [2] 319953 0
Timepoint 1: Baseline pre-training (day 1)
Timepoint 2: Post-training (day 43)
Timepoint 3: 3 month follow-up (day 141)
Primary outcome [3] 319954 0
Confidence: This will be measured by a change in total scores on an adapted version of the Confidence questionnaire (Sebbens, Hassmen, Crisp, and Wensley, 2016).
Timepoint [3] 319954 0
Timepoint 1: Baseline pre-training (day 1)
Timepoint 2: Post-training (day 43)
Timepoint 3: 3 month follow-up (day 141)
Secondary outcome [1] 369979 0
Helping Behaviours: This will be measured by a change in total scores on an adapted version of the Helping Behaviour questionnaire (Jorm et al., 2010).
Timepoint [1] 369979 0
Timepoint 1: Baseline pre-training (day 1)
Timepoint 2: Post-training (day 43)
Timepoint 3: 3 month follow-up (day 141)
Secondary outcome [2] 369981 0
Program Acceptability: Measured through a 13-item questionnaire developed for this study
Timepoint [2] 369981 0
Timepoint 2: Post-training (day 43)
Secondary outcome [3] 369983 0
Program Adherence: Measured through a 12-item questionnaire developed for this study, and analytic data on program usage start and complete times.
Timepoint [3] 369983 0
Timepoint 2: Post-training (day 43)
Secondary outcome [4] 371149 0
Program Implementation: Measured through a 15-item questionnaire adapted from the ORIC (Shea, C. M., Jacobs, S. R., Esserman, D. A., Bruce, K., & Weiner, B. J. 2014) and the NoMad (Finch, T.L., Girling, M., May, C.R., Mair, F.S., Murray, E., Treweek, S., Steen, I.N., McColl, E.M., Dickinson, C., Rapley, T., 2015).
Timepoint [4] 371149 0
Timepoint 2: Post-training (day 43)
Secondary outcome [5] 371150 0
Program Satisfaction: Measured through a 10-item questionnaire developed for this study.
Timepoint [5] 371150 0
Timepoint 3: 3 month follow-up (day 141)

Eligibility
Key inclusion criteria
Participants in this study will be secondary school teachers who:

1) Are currently employed full-time in the role of Year Advisor (or equivalent) for students at any secondary school in NSW. In recognition that the title of Year Advisor is not uniformly used across schools, the title can be interchangeable with other terms such as Student Co-ordinator or Head of Year. Participants must be teachers in school leadership positions who are responsible for overseeing a cohort of students, anywhere between Grade 7 and 12.
2) Are available and employed at their school for the duration of the study (approximately 8 weeks).
3) Are able to obtain the signed consent of their school principal.
4) Are from a school with at least one other Year Advisor participating.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. Non-randomised trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable. Non-randomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study will be an uncontrolled pre/post trial of the BEAM training program in a group of secondary school Year Advisors. Data will be collected at three time points: baseline, 6-weeks, and 3-month follow-up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Self-report data will be collected using the Black Dog Institute e-health platform and then analysed using SPSS statistical software v. 22.0 (SPSS Inc., Chicago, Il, USA). Outcome measures will be analysed using repeated-measures analyses to determine a difference between scores at time 1 (baseline) and scores at time 2 (post-test) as well as whether effects are sustained at 3-months follow up. Open response answers will be analysed qualitatively using thematic analysis.

Sample size calculations are based on detecting a medium effect size of 0.5, power at 0.8, and alpha of .05. This produces a sample size of 64 participants. As we wish to have a minimum of two Year Advisors per school participate, a total of 32 participating schools is the target.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2019
Actual
22/07/2019
Date of last participant enrolment
Anticipated
22/07/2019
Actual
4/08/2019
Date of last data collection
Anticipated
22/12/2019
Actual
16/12/2019
Sample size
Target
64
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302674 0
Other
Name [1] 302674 0
Black Dog Institute
Country [1] 302674 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 302605 0
None
Name [1] 302605 0
Address [1] 302605 0
Country [1] 302605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303296 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 303296 0
Ethics committee country [1] 303296 0
Australia
Date submitted for ethics approval [1] 303296 0
01/02/2019
Approval date [1] 303296 0
08/04/2019
Ethics approval number [1] 303296 0
HC190047

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

Contacts
Principal investigator
Name 93174 0
Dr Bridianne O'Dea
Address 93174 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 93174 0
Australia
Phone 93174 0
+61 2 93828509
Fax 93174 0
Email 93174 0
[email protected]
Contact person for public queries
Name 93175 0
Bridianne O'Dea
Address 93175 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 93175 0
Australia
Phone 93175 0
+61 2 93828509
Fax 93175 0
Email 93175 0
[email protected]
Contact person for scientific queries
Name 93176 0
Bridianne O'Dea
Address 93176 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 93176 0
Australia
Phone 93176 0
+61 2 93828509
Fax 93176 0
Email 93176 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
1991Ethical approval    377529-(Uploaded-03-05-2019-17-53-59)-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
SourceTitleYear of PublicationDOI
EmbaseExamining the Preliminary Effectiveness and Acceptability of a Web-Based Training Program for Australian Secondary School Teachers: Pilot Study of the BEAM (Building Educators Skills in Adolescent Mental Health) Program.2021https://dx.doi.org/10.2196/29989
N.B. These documents automatically identified may not have been verified by the study sponsor.