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Trial registered on ANZCTR


Registration number
ACTRN12617000033347
Ethics application status
Approved
Date submitted
21/12/2016
Date registered
9/01/2017
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a mental health literacy program on community leaders’ knowledge about and attitudes towards people with mental disorder in the Brong-Ahafo region in Ghana: Cluster randomised controlled trial
Scientific title
Effectiveness of a mental health literacy program on community leaders’ knowledge about and attitudes towards people with mental disorder in the Brong Ahafo region in Ghana: Cluster randomised controlled trial
Secondary ID [1] 290725 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Nil Known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Community leaders' knowledge about mental disorders. 301301 0
Community leaders' attitudes toward persons with mental disorders. 301302 0
Condition category
Condition code
Mental Health 301052 301052 0 0
Depression
Mental Health 301053 301053 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A mental health literacy training program on depression and schizophrenia, which revolves around the “Story bridge” (Lubman et al 2014) will be conducted for the intervention cluster. The program will be an interactive 3-hour session for each intervention cluster group. The training program will be delivered face to face, using a combination of Power-Point presentations, video-recordings and large- and small-group discussions, about people with depression and schizophrenia. Participants will also be given printed material about people with depression and schizophrenia: “Guidelines for Carers of Someone with a Mental Disorder” (www.mhfa.com). The training program will take place at participants' routine meeting place in their district, and will be delivered by Yaw Amankwa Arthur, a PhD Candidate.
Intervention code [1] 296625 0
Behaviour
Intervention code [2] 296709 0
Treatment: Other
Comparator / control treatment
The control cluster will be provided with a brochure containing basic information about mental health issues. The brochure is designed specifically for this project.
Control group
Active

Outcomes
Primary outcome [1] 300475 0
Change in attitudes and beliefs about mental health problems. This will be assessed using the Attitudes and Beliefs about Mental Health Problems: Professional and Public Views questionnaire (Jorm et al., 1999).
Timepoint [1] 300475 0
Data will be collected at two time points. Baseline (Week 0) and follow-up (Week 12)
Primary outcome [2] 300692 0
Change in attitudes about people with a mental disorder. This will be assessed using the Community Attitudes to Mental Disorder (CAMI) scale (Taylor & Dear, 1981).
Timepoint [2] 300692 0
Data will be collected at two time points. Baseline (week 0) and follow up (week 12)
Secondary outcome [1] 330348 0
None
Timepoint [1] 330348 0
None

Eligibility
Key inclusion criteria
All districts assemblies and current assembly members within the Brong Ahafo region of Ghana are potential clusters and participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A district assembly unit and / or an assembly member who has received prior training about mental disorders.
2. An assembly member with current or previous work experience as a mental health professional.

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)
Cluster allocation will be concealed. Allocation, which will be off-site, will be carried out by a researcher who is not directly involved in the recruitment process for the study. Randomisation will be then emailed to the researcher allocating participants to intervention and control groups in Ghana.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation generated by a computer.
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
In Brong Ahafo region there are 27 districts and a total of 766 elected assembly members. The study is planned with equally-sized control and treatment groups, with individuals clustered within districts, with each district comprising an average of 29 assembly members (approximately). For the control group, we anticipate a difference of 5 points in mental health literacy scores (as assessed by the Attitudes and Beliefs about Mental Health Problems: Public Views questionnaire (Jorm, Korten, Jacomb, Christensen, & Henderson, 1999) from baseline to 12 weeks. For the intervention group, we anticipate a change in 10 points in the intervention group cluster scores from baseline to 12 weeks. We anticipate data variability across both groups to be 10 points. We anticipate the intra-class correlation coefficient to be 0.03; of approximately medium magnitude. Hence, about 3% of total data variability is anticipated to occur between clusters; corresponding to a clustering design effect of 1.56.

At a 5% level of significance and a power of 80%, we would need to recruit a total of 128 participants (64 intervention group participants and 64 control group participants) to be able to reject the null hypothesis that the population means of the intervention and control group clusters are equal without clustering. Hence, we aim to recruit and cluster 2-3 intervention and 2- 3 control group clusters. To allow for some attrition, an additional 10% of the estimated sample size will be recruited, making a total of 140 participants.
Demographic characteristics of the participants will be summarised using frequencies and percentages. Analysis of Variance (ANOVA) will be conducted on the groups’ mean of the measures. Cronbach’s alpha will be used to assess the reliability of each scale at baseline. Pairwise comparisons will be undertaken to compare the different combinations between the three time points of the intervention and the control group clusters. The Chi-square will also be used to analyse the differences in knowledge, stigmatizing and discriminatory scores at baseline and follow-up time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
20/03/2017
Date of last participant enrolment
Anticipated
31/03/2017
Actual
11/04/2017
Date of last data collection
Anticipated
30/06/2017
Actual
14/07/2017
Sample size
Target
128
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 8474 0
Ghana
State/province [1] 8474 0
Brong-Ahafo region

Funding & Sponsors
Funding source category [1] 295154 0
University
Name [1] 295154 0
Victoria University, Institute for Health and Sport
Country [1] 295154 0
Australia
Primary sponsor type
Individual
Name
Professor Terence McCann
Address
Institute of Health and Sport
Victoria University
P. O. Box 14428
Melbourne
Victoria 8001
Australia
Country
Australia
Secondary sponsor category [1] 293976 0
University
Name [1] 293976 0
Victoria University, Institute of Health and Sport
Address [1] 293976 0
Victoria University
P. O. Box 14428
Melbourne
Victoria 8001
Australia
Country [1] 293976 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296506 0
Ghana Health Service Ethics Review Committee
Ethics committee address [1] 296506 0
Ethics committee country [1] 296506 0
Ghana
Date submitted for ethics approval [1] 296506 0
09/05/2016
Approval date [1] 296506 0
22/07/2016
Ethics approval number [1] 296506 0
GHS-ERC 09/05/16
Ethics committee name [2] 296507 0
Victoria University Human Research Ethics Committee
Ethics committee address [2] 296507 0
Ethics committee country [2] 296507 0
Australia
Date submitted for ethics approval [2] 296507 0
27/05/2016
Approval date [2] 296507 0
12/09/2016
Ethics approval number [2] 296507 0
HRE16-140

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

Contacts
Principal investigator
Name 71090 0
Prof Terence McCann
Address 71090 0
Institute for Health and Sport, Victoria University P. O. Box 14428 Melbourne Victoria 8001 Australia
Country 71090 0
Australia
Phone 71090 0
+ 61399192325
Fax 71090 0
+61399192325
Email 71090 0
terence.McCann@vu.edu.au
Contact person for public queries
Name 71091 0
Terence McCann
Address 71091 0
Institute for Health and Sport, Victoria University P. O. Box 14428 Melbourne Victoria 8001 Australia
Country 71091 0
Australia
Phone 71091 0
+ 61399192325
Fax 71091 0
+ 61399192325
Email 71091 0
terence.McCann@vu.edu.au
Contact person for scientific queries
Name 71092 0
Terence McCann
Address 71092 0
Institute for Health and Sport, Victoria University P. O. Box 14428 Melbourne Victoria 8001 Australia
Country 71092 0
Australia
Phone 71092 0
+ 61399192325
Fax 71092 0
+ 61399192325
Email 71092 0
terence.McCann@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval was not obtained to make IPD available


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.