Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001181998
Ethics application status
Approved
Date submitted
14/11/2011
Date registered
14/11/2011
Date last updated
14/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mental Health First Aid for Eating Disorders: evaluation of a training program for the public
Scientific title
Pilot uncontrolled trial of an eating disorder mental health first aid training program to improve mental health literacy, stigmatising attitudes and supportive first aid behaviours among college students.
Secondary ID [1] 273385 0
NIL
Universal Trial Number (UTN)
U1111-1125-7959
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health literacy 279160 0
stigmatising attitudes 279161 0
eating disorders 279162 0
supportive first aid behaviours 279165 0
Condition category
Condition code
Mental Health 279349 279349 0 0
Eating disorders
Public Health 279359 279359 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The training intervention was a 4-hour single-session, classroom-style, education program designed to be presented to groups of between 5 and 15 people. It included didactic teaching using a Powerpoint presentation, small-group learning activities (in pairs or threes) and whole-group discussion components. A teaching manual was developed to guide facilitation and ensure fidelity. Training was delivered by one primary instructor with a second facilitator assisting with group activities and participant questions. It included information on warning signs and risk factors for the development of an eating disorder, types of eating disorders and current evidence based treatments, how to provide mental health first aid for eating disorders using the MHFA action plan and how to assist in a mental health crisis.
Intervention code [1] 283715 0
Behaviour
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285947 0
problem recognition item within the Mental Health Literacy Questionnaire for Bulimic Type eating disorders (Mond etal, 2007)
Timepoint [1] 285947 0
baseline, post-training, six-month follow-up
Secondary outcome [1] 294826 0
Total score on the First Aid Knowledge Test
Timepoint [1] 294826 0
baseline, post-training, six-month follow-up

Eligibility
Key inclusion criteria
Residing at a residential college affiliated with the University of Melbourne in either a student or staff welfare tutor role.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-attendance at the training intervention session

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)
Recruitment advertisements were posted as flyers on noticeboards around residences, presented orally at dinner meetings, or written in weekly news emails. The advertisements included information about eating disorders and MHFA training. Student and staff training sessions were run separately. As this was a non-randomised uncontrolled trial, there were no allocation procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NIL
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284198 0
Charities/Societies/Foundations
Name [1] 284198 0
Australian Rotary Health
Country [1] 284198 0
Australia
Primary sponsor type
University
Name
University Of Melbourne
Address
Centre for Youth Mental Health
University of Melbourne
Locked bag 10
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 269159 0
Individual
Name [1] 269159 0
Professor Anthony Jorm
Address [1] 269159 0
Primary Supervisor
Centre for Youth Mental Health
University of Melbourne
Locked bag 10
Parkville VIC 3052
Country [1] 269159 0
Australia
Other collaborator category [1] 260344 0
Individual
Name [1] 260344 0
Laura Hart
Address [1] 260344 0
PhD Student
Centre for Youth Mental Health
University of Melbourne
Locked bag 10
Parkville VIC 3052
Country [1] 260344 0
Australia
Other collaborator category [2] 260345 0
Individual
Name [2] 260345 0
Professor Susan Paxton
Address [2] 260345 0
Secondary Supervisor
School of Psychological Science
La Trobe University
Bundoora VIC 3083
Country [2] 260345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286164 0
University of Melbourne, Department of Psychiatry, Human Ethics Adivory Group
Ethics committee address [1] 286164 0
Ethics committee country [1] 286164 0
Australia
Date submitted for ethics approval [1] 286164 0
16/09/2009
Approval date [1] 286164 0
09/11/2009
Ethics approval number [1] 286164 0
0932473

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

Contacts
Principal investigator
Name 33379 0
Address 33379 0
Country 33379 0
Phone 33379 0
Fax 33379 0
Email 33379 0
Contact person for public queries
Name 16626 0
Laura Hart
Address 16626 0
Centre for Youth Mental Health
University of Melbourne
Locked Bag 10
Parkville Vic 3052
Country 16626 0
Australia
Phone 16626 0
+61393423761
Fax 16626 0
Email 16626 0
lhart@unimelb.edu.au
Contact person for scientific queries
Name 7554 0
Laura Hart
Address 7554 0
Centre for Youth Mental Health
University of Melbourne
Locked Bag 10
Parkville Vic 3052
Country 7554 0
Australia
Phone 7554 0
+61393423761
Fax 7554 0
Email 7554 0
lhart@unimelb.edu.au

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.