Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308849574524 Date of Approval: 31/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of a mental health literacy e-curriculum (MHLeC) in Malawi universities: the MHLeC feasibility trial
Official scientific title Implementation of a mental health literacy e-curriculum (MHLeC) in Malawi universities: the MHLeC feasibility trial
Brief summary describing the background and objectives of the trial Depression in Malawi is common with prevalence rates of up to 30% among the youth. However, mental health literacy (MHL) in Malawi is very limited. Many people attribute mental illness to alcohol and drug abuse or spirit possession, resulting in stigma, maltreatment, and discrimination towards people with mental health problems. Inadequacies in the country’s mental health services and workforce amplify limited treatment access, knowledge, and negative attitudes, consequently resulting in epidemic rises in substance use and suicides. Improving MHL, which helps improve the identification and treatment of mental illness whilst decreasing stigma among youth in Malawi is vital. We have modified a Canadian school-based MHL resource adapted for application in sub-Saharan Africa into an online curriculum (MHLeC) and piloted its delivery in a Malawi university with promising outcomes. This project aims to assess the implementation of this MHL e-curriculum in 4 Malawi universities within a feasibility randomised trial. We will also assess the acceptability of the curriculum, appropriateness of chosen outcome measures, and potential impact on MHL. Expected project outcomes include enhanced mental health literacy among participants, including improvements in mental well-being, help-seeking, and peer support. Expected key impacts include improved well-being within our target population (youth) and the educational community, along with mental health capacity building from the supervision of postgraduate researchers. Our advisory group and local collaborators like the National Youth Council of Malawi, will help us with youth community engagement mental health activities. We will disseminate research findings at relevant national and international conferences like Africa Health Agenda, and non-academic platforms like social media and radio, and develop regional partnerships for future work. If the results are positive, our intervention can be rolled out nationally and tested in other parts of Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MHLeC feasibility trial
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 04/09/2023
Actual trial start date
Anticipated date of last follow up 31/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 134
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Voluntary MHLeC 1 dose 6 sessions, each lasting about 80 minutes Interested students of the voluntary arm will be told to join a mental health club where they can participate in the MHLeC sessions online. MHLeC registration will include reading through the participant information sheet, providing informed consent, and completing baseline questionnaires that will include basic demographic questions, two Mental Health Literacy (MHL) questionnaires, Patient Health Questionnaire-9 and The Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) tool either by using the printed or online questionnaires based on their preference. Students will be encouraged to seek clarification from the research team where necessary and will be given the Principal Investigator’s contacts to ask questions over the study duration. Once the baseline questionnaires are completed and the study team has ensured that the students meet the eligibility criteria, they will be classed as fully registered onto MHLeC and subsequently receive a confirmation email a few days later containing a date for their first MHLeC online session and the deadline to complete their last session. Those who successfully complete the MHLeC sessions will receive a certificate of completion. Participating students will be contacted again three months after their last MHLeC session, to complete post-MHLeC questionnaires used to assess long-term retention of mental health knowledge, and overall changes in MHL, mental wellbeing, and substance use. 67
Control Group Mandatory MHLeC 1 Six sessions each lasting about 80 minutes per session Students will be told that completion of the MHLeC is mandatory or voluntary based on the arm of the trial that their university is randomised into. Students in the mandatory arm will be told that their attendance to MHLeC sessions is obligatory and will be conducted in a classroom. MHLeC registration will include reading through the participant information sheet, providing informed consent, and completing baseline questionnaires that will include basic demographic questions, two Mental Health Literacy (MHL) questionnaires, Patient Health Questionnaire-9 and The Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) tool either by using the printed or online questionnaires based on their preference. Students will be encouraged to seek clarification from the research team where necessary and will be given the Principal Investigator’s contacts to ask questions over the study duration. Once the baseline questionnaires are completed and the study team has ensured that the students meet the eligibility criteria, they will be classed as fully registered onto MHLeC and subsequently receive a confirmation email a few days later containing a date for their first MHLeC classroom session and subsequent planned five sessions. Those who successfully complete the MHLeC sessions will receive a certificate of completion. Participating students will be contacted again three months after their last MHLeC session, to complete post-MHLeC questionnaires used to assess long-term retention of mental health knowledge, and overall changes in MHL, mental well-being, and substance use. 67 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For Universities: Public or private university in Malawi, Curriculum taught in English or Chichewa medium (N.B: the main medium of delivery is English), Infrastructure for delivery of online teaching to students. For Students: Any first-year student, Fully enrolled in participating university (Student ID numbers will be used to validate status), Able and willing to give written informed consent, People willing to commit to participate in at least 4 out of the 6 MHLeC sessions and engage with the online curriculum by themselves to complete assessments, People who can use smartphones, laptops or PCs with a stable internet connection, with or without support from others. Exclusion criteria for student participants includes: Those unwilling or unable to give consent independently, Inability to understand written and/ or verbal English or Chichewa, People judged to be unsuitable for participation in this research by the research team due to severe mental or cognitive problems (memory problems, Patient Health Questionnaire-9 severe depression score). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 12/07/2023 National Committee on Research in the Social Sciences and Humanities
Ethics Committee Address
Street address City Postal code Country
First Floor, Lingadzi House, Lilongwe PBag B303 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the proportion of students completing the MHLeC, we will review attendance rates during the classroom sessions. Specifically, we will calculate completion by dividing ‘the number of study participants who attended four or more classroom sessions’ by ‘the total number of people registered in each university cohort’. The proportion of students completing the online MHLeC will be calculated by dividing ‘the number of study participants who complete the final MLHeC online assessment’ by ‘the number of people registered in this study’. After MHLEC delivery in each arms - final MHLEC assessment
Secondary Outcome Questionnaires completion rate Questionnaires’ completion proportion will be calculated by dividing ‘the number of people who have completed their questionnaires at baseline, immediately after the MHLeC intervention and 12 weeks later’ by ‘the total number of consenting student participants in this study’. The questionnaires to be completed are detailed below: 1. Mental health literacy questionnaire (MHLq) for young adults Assesses the general mental health knowledge in general populations has shown strong evidence for content validity, internal consistency, and moderate reliability. 2. The School Mental Health Questionnaire (SMHQ) Contains a series of surveys that measure mental health knowledge, attitudes toward mental health and mental illness (stigma against mental illness), and outlook toward help-seeking. 3. Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a nine-item questionnaire for measuring the severity of depressive disorder symptoms, and verification of the reliability and validity of the Chichewa version has already been reported. 4. The Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) tool The CRAFFT is a well-validated substance use screening tool for adolescents and young adults aged 12-21, typically used for preventive care screenings. Questionnaires will be measured before the MHLeC, and 3 months after MHLeC.
Secondary Outcome The acceptability of the MHLeC content, assessed using qualitative focus group discussions with students who participated in the trial and MHLeC facilitators - process evaluation Three months after the delivery of MHLeC sessions.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Millennium University Magalasi, Nyambadwe Blantyre Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
The African Academy of Sciences 8 Miotoni Lane, Karen, Nairobi Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Millennium University Nyambadwe Magalasi Road Blantyre Malawi University
COLLABORATORS
Name Street address City Postal code Country
Drug Fight Malawi n/a Lilongwe 424 Malawi
The National Youth Council of Malawi Off Presidential Highway, Area 14, Plot number 106 Lilongwe Malawi
As we grow lets talk about it n/a Blantyre Malawi
Queen Mary University of London Wolfson Institute of Population Health Yvonne Carter Building, 58 Turner Street London E1 2AB United Kingdom
The National Council for Higher Education n/a Lilongwe Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sandra Jumbe sjumbe@mu.ac.mw +447920403708 Magalasi Road, Nyambadwe
City Postal code Country Position/Affiliation
Blantyre Malawi Senior Lecturer of Research
Role Name Email Phone Street address
Public Enquiries Gase Motshewa gase@mu.ac.mw +265884674887 Magalasi road, Nyambadwe
City Postal code Country Position/Affiliation
Blantyre Malawi Director of Quality Assurance
Role Name Email Phone Street address
Scientific Enquiries Sandra Jumbe sjumbe@mu.ac.mw +447920403708 Millennium University, Magalasi road, Nyambadwe
City Postal code Country Position/Affiliation
Blantyre Malawi Senior Lecturer in Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data for the trial including data dictionaries will be shared. The data will include all of the unidentified individual participant data collected during the trial. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be shared immediately following publication with no end date. Anyone who wishes to access the data for any purpose can access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information