Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000033246
Ethics application status
Approved
Date submitted
26/11/2008
Date registered
19/01/2009
Date last updated
12/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Youth Mental Health First Aid Course
Scientific title
An evaluation of the effects of face-to-face training for adults who have undertaken the youth mental health first aid course and its impact on recognition of mental disorders, stigmatising attitudes, confidence in providing mental health first aid and number of helping behaviours towards adolescents with mental health problems or in a mental health crisis.
Secondary ID [1] 294588 0
Nil known
Universal Trial Number (UTN)
U1111-1205-1072
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recognition of mental disorders - by participants of the Youth Mental Health First Aid Course. 4022 0
stigmatizing attitudes - of participants in the the Youth Mental Health First Aid Course. 4024 0
confidence in providing mental health first aid - by participants in the Youth Mental Health First Aid Course. 4025 0
number of first aid actions taken to help adolescents with mental health problems - by participants in the Youth Mental Health First Aid Course 4026 0
Condition category
Condition code
Mental Health 4227 4227 0 0
Anxiety
Mental Health 4228 4228 0 0
Depression
Mental Health 4417 4417 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 14 hour face-to-face course in Youth Mental Health First Aid. The course teaches participants how to assist a young person developing a mental health problem or in a mental health crisis. Topics covered are: depression, anxiety disorders, psychosis, substance use disorders, eating disorders and deliberate self-harm. The 14-hour course was presented on either 2 days of 7 hours duration over a 2 week period, or on 4 separate sessions of three and a half hours duration, on a weekly basis and span over 4 weeks.
Intervention code [1] 3747 0
Early detection / Screening
Comparator / control treatment
Not applicable as this is a Non-randomised single group study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5118 0
Recognition of mental disorders (Kitchener & Jorm, 2002 B). Uses some of the questions from the National Survey of Mental Health Literacy (1997) depicting 2 vignettes: depression and schizophrenia.
Timepoint [1] 5118 0
At baseline prior to commencing course, on conclusion of the course and at 6-month follow-up.
Primary outcome [2] 5119 0
stigmatizing attitudes - measured by Personal and Perceived Stigma Scales (Griffiths et al., 2006) and modified to suit attitudes of adolescents.
Timepoint [2] 5119 0
At baseline prior to commencing course, on conclusion of the course and at 6-month follow-up.
Secondary outcome [1] 8619 0
Confidence in providing first aid (5-point scale which rates confidence in providing mental health first aid for 2 vignettes depicting depression and schizophrenia)
Timepoint [1] 8619 0
At baseline prior to commencing course, on conclusion of the course and at 6-month follow-up.
Secondary outcome [2] 8620 0
First aid intentions (Jorm et al., 2005). Open-ended question for depression and schizophrenia vignettes, which asks participant how they would help a person in each vignette.
Timepoint [2] 8620 0
At baseline prior to commencing course, on conclusion of the course and at 6-month follow-up.
Secondary outcome [3] 8621 0
Number of first-aid actions - asks if participant has talked to a young person about a mental health problem in last 6 months and includes actions to tick in checkbox (adaped from Kitchener & Jorm, 2002).
Timepoint [3] 8621 0
At baseline and at 6-month follow-up.

Eligibility
Key inclusion criteria
Adult members of the general public. Minimum size of training group will be 5 participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maximum size of training group will be 20 people.

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)
Participants will be recruited through public advertising in local media in the North-western metropolitan region and Geelong, in conjunction with local area mental health services. Participants will be required to attend the 14-hour training course over either 2 training days of 7 hours duration, or 4 separate weekly sessions of 3.5 hours duration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2007
Actual
20/08/2007
Date of last participant enrolment
Anticipated
Actual
14/03/2008
Date of last data collection
Anticipated
Actual
21/11/2008
Sample size
Target
240
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 1312 0
3215
Recruitment postcode(s) [2] 1313 0
3047
Recruitment postcode(s) [3] 1314 0
3429
Recruitment postcode(s) [4] 1315 0
3011

Funding & Sponsors
Funding source category [1] 4209 0
University
Name [1] 4209 0
The University of Melbourne
Country [1] 4209 0
Australia
Primary sponsor type
Individual
Name
Anthony Jorm
Address
Orygen YOUTH Health Research Centre
35 Poplar Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 3948 0
Individual
Name [1] 3948 0
Betty Kitchener
Address [1] 3948 0
Orygen YOUTH Health Research Centre
35 Poplar Road
Parkville VIC 3052
Country [1] 3948 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6262 0
The University of Melbourne's Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 6262 0
Ethics committee country [1] 6262 0
Australia
Date submitted for ethics approval [1] 6262 0
Approval date [1] 6262 0
16/07/2007
Ethics approval number [1] 6262 0
0714470

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

Contacts
Principal investigator
Name 29164 0
Dr Claire M Kelly
Address 29164 0
Manager of Youth Programs
MHFA Australia
Level 6, 369 Royal Parade
Parkville VIC 3052
Country 29164 0
Australia
Phone 29164 0
+61390790203
Fax 29164 0
Email 29164 0
[email protected]
Contact person for public queries
Name 12321 0
Julie-Anne Fischer
Address 12321 0
Trial Manager
Centre for Mental Health, Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
The University of Melbourne
Carlton VIC 3010
Country 12321 0
Australia
Phone 12321 0
+61390356770
Fax 12321 0
N/A
Email 12321 0
[email protected]
Contact person for scientific queries
Name 3249 0
Professor Anthony Jorm
Address 3249 0
Professorial Fellow and NHMRC Senior Principal Research Fellow, Centre for Mental Health Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
The University of Melbourne
Carlton VIC 3010
Country 3249 0
Australia
Phone 3249 0
+61 3 90357799
Fax 3249 0
N/A
Email 3249 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
No additional documents have been identified.