Mental health first aid training for China: a randomised controlled trial
| ISRCTN | ISRCTN21096283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21096283 |
| Secondary identifying numbers | GNT1142395 |
- Submission date
- 14/02/2023
- Registration date
- 18/02/2023
- Last edited
- 19/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Many people who meet the criteria for a mental disorder do not receive appropriate professional help. Improving professional help-seeking is likely to require improvements in mental health literacy as well as structural reform of services. Given the high likelihood of contact with a person with a common mental health problem, interventions that teach members of the public to provide early help towards a person developing a mental health problem or in a mental health crisis may play a role in improving access to services, social support, and mental health outcomes. Mental health first aid is the help offered to a person developing a mental health problem, or experiencing a worsening of an existing mental health problem or in a mental health crisis; the first aid is given until appropriate professional help is received or until the crisis resolves. This course, and related programs, have been developed by Mental Health First Aid (MHFA) International, a not-for-profit organisation that has disseminated the courses to organisations in over 25 other (mostly high-income) countries, which then facilitate the training and accreditation of instructors in those countries. However, MHFA trials have only been conducted in high-income countries. The appropriateness of the training for countries with less well-resourced mental health systems and cultural differences relevant to mental health is unknown. The current study will evaluate the effectiveness of culturally adapted MHFA Training for China. It will be a collaboration between three partner organisations: the University of Melbourne, MHFA International and the Shanghai Mental Health Center (SMHC).
Who can participate?
All participants (adults aged 18 years old and over) in each of the study settings in accordance with the criteria
What does the study involve?
The study will be conducted in 6 settings in Shanghai, two health services, two workplaces and two community settings, with each setting defined as a cluster. Intervention settings will be paired according to type and one of each pair will be randomly allocated to the intervention (the MHFA Training for China) or the wait-list control group, with a 1:1 allocation.
Participants will be asked to complete questionnaires at baseline (T1) and 1 month (T2) and 7 months after completing the training (T3). Participants in the control group will be asked to complete questionnaires at corresponding times. The primary outcome will be intended support towards someone experiencing a mental health problem or in a mental health crisis. Secondary outcome measures will include recognition of depression in a vignette; beliefs about the helpfulness of interventions for mental health problems; helping actions taken; confidence in providing mental health first aid; stigmatising attitudes; and desire for social distance from a person with a mental health problem.
What are the possible benefits and risks of participating?
Possible benefits include improved mental health literacy and capacity to help a person developing mental health problems or in a mental health crisis. Risks may include distress related to discussing poor mental health.
Where is the study run from?
Shanghai Mental Health Center (China)
When is the study starting and how long is it expected to run for?
October 2022 to May 2025
Who is funding the study?
The National Health and Medical Research Council (Australia)
Who is the main contact?
Dr Yanling He, heyanling@smhc.org.cn (China)
Prof Nicola Reavley, nreavley@unimelb.edu.au (Australia)
Contact information
Principal Investigator
University of Melbourne
Centre for Mental Health
Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
Victoria
3010
Australia
 ORCID ID |
0000-0001-5513-8291 |
|---|---|
| Phone | +61 3 9035 7628 |
| nreavley@unimelb.edu.au |
Scientific
600 Wan Ping Nan Lu
Shanghai
200030
China
| Phone | +86 13916584841 |
|---|---|
| heyanling@smhc.org.cn |
Public
University of Melbourne
Centre for Mental Health
Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
Victoria
3010
Australia
| Phone | +61 3 9035 7628 |
|---|---|
| nreavley@unimelb.edu.au |
Study information
| Study design | Randomized waitlist control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community, Hospital, Workplace |
| Study type | Other |
| Participant information sheet | 43219_PIS.pdf |
| Scientific title | Mental health first aid training for China: a randomised controlled trial |
| Study acronym | MHFA-China |
| Study objectives | The study hypothesis is that Mental health first aid (MHFA) training in China will be more effective than no intervention (wait-list control) in improving participant intentions to help someone developing a mental health problem or in a mental health crisis; helping actions taken to assist a person in this situation; confidence in providing mental health first aid; stigmatising attitudes; desire for social distance from a person with a mental health problem. |
| Ethics approval(s) |
Approved 02/02/2023, University of Melbourne Human Research Ethics Committee (The University of Melbourne, Office of Research Ethics and Integrity, Research, Innovation & Commercialisation, Level 5, Alan Gilbert Building, 161 Barry Street, Carlton, Victoria, 3010, Australia; +61 3 8344 7895; HumanEthics-Enquiries@unimelb.edu.au), ref: 2023-25658-36173-4 |
| Health condition(s) or problem(s) studied | Mental health literacy and stigma |
| Intervention | The intervention Mental health first aid (MHFA) training for China is a major adaptation based on the Australian Standard MHFA 12-hour course. Course adaptation was undertaken members of the Shanghai Mental Health Center (SMHC) research team. As with the Australian MHFA materials, the MHFA China course includes an MHFA China manual, instructor teaching notes, PowerPoint slides, videos and activities that allow participants to practice their new skills. The content of the MHFA China manual was informed by guidelines developed in five Delphi expert consensus studies, undertaken in China with health professionals, people with lived experience and carers. The results of these studies outline culturally-appropriate actions to be taken to help a person developing depression, psychosis, problem drinking, at risk of suicide or at risk from a potentially traumatic event. Using these guidelines, the team came up with a simplified MHFA Action Plan, more suitable for countries that do not have good mental health literacy and good pathways to mental health care. The new Action Plan is: Recognise, Engage, Keep safe, and Support. The manual was organized into chapters covering each of these actions. Based on this manual, the teaching and curriculum notes were developed. The resulting English-language manual, teaching materials and PowerPoint slides were translated into Mandarin Chinese. Subtitles for three of the Australian MHFA videos were also translated. The course will be delivered over 2 days and will be conducted in health services, workplaces and community settings by instructors from SMHC. Training will be offered to approximately 20 participants per course group through face-to-face delivery, depending on COVID-19 restrictions in Shanghai. Randomisation Clusters will be paired according to setting (health services, workplaces and community settings) and randomly assigned to either the intervention or the control group with a 1:1 allocation. After the trial manager has recruited a pair of clusters, they will send the independent statistician blinded details about the clusters and the statistician will generate the allocation using a random sequence generator within Stata. Due to the nature of the intervention, it will not be possible to blind participants to allocation. However, neither participants nor the cluster will be notified of the allocation prior to trial enrolment. Data analysis will be conducted blinded to allocation. |
| Intervention type | Behavioural |
| Primary outcome measure | Intentions to provide mental health first aid measured using the Mental health support scale – Intended at baseline (T1), 1 month (T2) and 7 months after completing the training (T3) |
| Secondary outcome measures | 1. Recognition of depression measured by asking the participant to write a vignette at baseline, 1-month and 7 months 2. Beliefs about treatment and mental health professionals measured using a Chinese adaptation of a 16-item scale used in a Mental Health First Aid (MHFA) trial in Australia, at baseline, 1-month and 7 months 3. Confidence in providing MHFA for a person with depression measured by asking participants to rate how confident they would feel supporting this person, at baseline, 1-month and 7 months 4. Helping actions taken to assist a person with depression measured using the MHSS-Provided subscale Chinese version at baseline and 7 months 5. Desire for social distance from a person with a mental health problem measured using the Link Social Distance Scale at baseline, 1-month and 7 months 6. Personally stigmatising attitudes about a person with depression, measured using the Depression Stigma Scale at baseline, 1-month and 7 months 7. Course quality and satisfaction measured using a 5-item questionnaire at 1 month |
| Overall study start date | 01/10/2022 |
| Completion date | 01/05/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | Adults aged 18 years old and over |
| Key exclusion criteria | 1. Previously completed an MHFA course 2. Low level of literacy (below middle school) 3. A high level of mental health knowledge based on their professional role (e.g., psychologists and psychiatrists) |
| Date of first enrolment | 15/02/2024 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200032
China
Sponsor information
University/education
207 Bouverie St
Parkville
3010
Australia
| Phone | +61 3 9035 5511 |
|---|---|
| ric-medresearch@unimelb.edu.au | |
| Website | http://unimelb.edu.au |
"ROR" |
https://ror.org/01ej9dk98 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | 01/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. Conference presentations |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available on request from Prof Nicola Reavley (nreavley@unimelb.edu.au). The type of data that will be shared is de-identified data stored in a repository. These data will be available subsequent to any publications and for up to 15 years. Consent from participants was required and obtained on the Plain Language Statement. A unique identifier for each participant will be generated, allowing data linkage across time points. The research team will keep a separate, secure record matching participants’ personal information with their unique identifiers. No ethical or legal restrictions have been identified. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Plain Language Statement | 15/02/2023 | No | Yes |
Additional files
- 43219_PIS.pdf
- Plain Language Statement
Editorial Notes
19/12/2023: The following changes were made:
1. The recruitment start date was changed from 01/12/2023 to 15/02/2024.
2. The recruitment end date was changed from 01/05/2024 to 01/06/2024.
26/10/2023: The following changes were made:
1. The recruitment start date was changed from 01/05/2023 to 01/12/2023.
2. The recruitment end date was changed from 01/10/2023 to 01/05/2024.
15/02/2023: Trial's existence confirmed by the University of Melbourne Office of Research Ethics and Integrity (Australia).
