Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000861651
Ethics application status
Approved
Date submitted
18/07/2014
Date registered
11/08/2014
Date last updated
11/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Trial to Measure Efficacy of Training Nursing Students in Mental Health First Aid
Scientific title
A randomised controlled trial to measure the efficacy of delivering Mental Health First Aid training to first year nursing students at Curtin University.
Secondary ID [1] 284742 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health literacy and helping skills 292109 0
Condition category
Condition code
Mental Health 292441 292441 0 0
Depression
Mental Health 292754 292754 0 0
Psychosis and personality disorders
Mental Health 292755 292755 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in a face to face 13 hour Mental Health First Aid (MHFA) course. The course will run over 2 days consisting of 2 x 6.5 hour sessions.
The MHFA course addresses several mental health issues such as depression, anxiety, suicide, eating disorders, and self injury. The course used videos, group activities and the MHFA manual to work through the course content.
Intervention code [1] 289527 0
Behaviour
Comparator / control treatment
The control will have no exposure other than any usual mental health promotion.
The control group will be offered the online MHFA course at 2 months after the second post questionnaire has been completed by all participants.
Control group
Active

Outcomes
Primary outcome [1] 292297 0
Mental health literacy including: stigma toward people with a mental health problem, social distance, confidence, helping behaviours and knowledge.
These outcomes will be assessed by using a existing pre and post questionnaire created by Mental Health First Aid Australia.
Timepoint [1] 292297 0
Baseline (pre Mental Health Fist Aid course), post Mental Health First Aid course and 2 month follow-up
Secondary outcome [1] 309359 0
nil
Timepoint [1] 309359 0
nil

Eligibility
Key inclusion criteria
First year, internally enrolled Curtin University nursing students at the Bentley campus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under the age of 18 years and not enrolled in first year nursing, not enrolled internally, or not at the Bentley campus

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)
Central randomisation by computer by centrally based administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once all students have been allocated an identifying number, using the RAND function in Excel, students will be randomly allocated into two groups, intervention or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been determined by the practicalities of working in a large university which requires delivering the intervention when it will be convenient to run classes that fitted university scheduling requirements and clinical rotations for the students. Assuming a high correlation of 0.8 for the baseline-post measurements it will be necessary to have 50 students in each group to detect 5% level of significance with 90% power in order to detect medium effect sizes for both continuous and dichotomous outcomes. A total of 63 students will be recruited for each group to account for 20% attrition from baseline to post intervention.The intention-to-treat principle will be used in the analysis, where all participants who completed the baseline questionnaire will be included in analysis regardless whether they complete the whole intervention. Acknowledging there may be attrition at the follow-up, the missing values for the non-respondents will be their baseline scores. This will assure no false improvement in efficacy. Data will be analysed using SPSS Version 22.

The demographics of the participants in the intervention and control groups will be compared using the independent samples t-test or Pearson’s Chi-square test to measure differences including gender, country of birth. The primary outcome measures (described above) will be calculated following validated MHFA scoring methods reported in the literature. Repeated measures analysis of variance will be employed to assess continuous measures with the intervention and control group over three time points (baseline, post intervention and six weeks post intervention). Logistic regression will used to assess changes in dichotomous variables. The significance level will be set at 5%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
3/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8430 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 289579 0
University
Name [1] 289579 0
Seed Funding Grant - School of Public Health Curtin University
Country [1] 289579 0
Australia
Primary sponsor type
University
Name
WA Centre for Health Promotion Research - Curtin University
Address
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country
Australia
Secondary sponsor category [1] 288263 0
None
Name [1] 288263 0
Address [1] 288263 0
Country [1] 288263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291315 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291315 0
Ethics committee country [1] 291315 0
Australia
Date submitted for ethics approval [1] 291315 0
Approval date [1] 291315 0
01/11/2013
Ethics approval number [1] 291315 0
SPH-74-2013

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

Contacts
Principal investigator
Name 48986 0
Ms Gemma Crawford
Address 48986 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 48986 0
Australia
Phone 48986 0
+61 8 9266 4851
Fax 48986 0
Email 48986 0
[email protected]
Contact person for public queries
Name 48987 0
Gemma Crawford
Address 48987 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 48987 0
Australia
Phone 48987 0
+61 8 9266 4851
Fax 48987 0
Email 48987 0
[email protected]
Contact person for scientific queries
Name 48988 0
Gemma Crawford
Address 48988 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 48988 0
Australia
Phone 48988 0
+61 8 9266 4851
Fax 48988 0
Email 48988 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseMental health first aid training for nursing students: A protocol for a pragmatic randomised controlled trial in a large university.2015https://dx.doi.org/10.1186/s12888-015-0403-3
N.B. These documents automatically identified may not have been verified by the study sponsor.