Mental Health IssueNCT06148922
Brief Mental Health First Aid Program (bMHFA) for Parents to Improve Mental Health Literacy in Low-Income Families: A Three-Arm Cluster Randomized Controlled Trial
A study testing Brief Mental Health First Aid Workshop and Semi-structured interviews in people with Mental Health Issue, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this Randomized Controlled Trial study is to test the effectiveness of the brief Mental Health First Aid Program (bMHFA) for parents to improve Mental Health Literacy in Low-Income families. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Brief Mental Health First Aid Workshop and Semi-structured interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or above
- able to speak Cantonese and read Chinese
- parenting at least one child aged 8-13 years
- receiving Comprehensive Social Security Assistance or have a household income less than the half of the median
- Children must be able to speak Cantonese and read Chinese
Who cannot join
- Parents and children with identified cognitive, behavioral, or mental problems will be excluded
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The polytechnic university of Hong Kong
Hong Kong
About this study
The goal of this Randomized Controlled Trial study is to test the effectiveness of the brief Mental Health First Aid Program (bMHFA) for parents to improve Mental Health Literacy in Low-Income families. The main questions it aims to answer are:
- Does the brief MHFA program improve mental health literacy among parents in low-income families?
- Does the brief MHFA program improve mental well-being among children in low-income families?
Read more
Participants will be randomly assigned to two groups, intervention and control group.
- Intervention group: attend a 2-hour training program on brief MHFA
- Intervention group: complete a set of questionnaire
- Intervention group: Interviews will be conducted at 12-month follow up
- Control: no need to attend any workshop
- Control: complete a set of questionnaire
Read the detailed description
The traditional MHFA program covers many more mental disorders. Parents in the intervention group will receive a 2-hour workshop delivered by a registered nurse who has a MHFA training certificate from the Mental Health Association of Hong Kong. The first part includes an introduction that defines mental health and identifies mental health crises and symptoms, risk factors, and impacts. The second part of the workshop involves teaching parents the five key ALGEE techniques. The final part of the workshop concerns application of ALGEE in common types of mental disorders, including depression, anxiety, suicidal thoughts and behaviors, and substance abuse. Interviews will be held after 12-month of the intervention.
While the other group (control) will just have to complete a set of questionnaire, same set also need to complete by the intervention group.
- Conditions
- Mental Health Issue
- Being tested
- Brief Mental Health First Aid Workshop, Semi-structured interviews
- Keywords
- Low-Income families, Parents, Mental Health First Aid (MHFA), brief intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Mental Health First Aid WorkshopOther
a 2-hour workshop delivered by a registered nurse with a MHFA training certificate
Semi-structured interviewsOther
One-to-one, face-to-face semi-structured interviews will be conducted by a research assistant. The duration would be around 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group parents will receive a 2-hour workshop delivered by a registered nurse with a MHFA training certificate, in groups of up to 10 parents. Parents will receive a leaflet summarizing the training contents after the workshop. At 1 week and 1-, 3-, and 6-month follow-ups, the trained registered nurse will send a 5-minute reminder video via WhatsApp/WeChat to parents describing the key MHFA techniques. A set of online questionnaires will also be delivered to the parent-child dyads at these follow-ups. Receives: Other: Brief Mental Health First Aid Workshop |
| Control | No intervention | The control group will receive no intervention. Only completing the sets of questionnaire. |
| Intervention (Interview) | Other | Parents in the intervention group with the highest and lowest mental health literacy scores will be purposively invited to participate in one-to-one semi-structured interviews to explore their experience of the intervention. Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' level of mental health literacy
Chinese version of the mental health literacy scale
Measured: 12-month follow-up
Secondary outcomes (4)
Parents' level of mental health literacy
Chinese version of the mental health literacy scale
Measured: 1-week and 1-, 3-, and 6- month follow-ups
Children's self-esteem
Chinese version of the Rosenberg Self-Esteem Scale
Measured: baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups
Children's depressive symptoms
Chinese version of the Center for Epidemiological Studies Depression Scale for Children
Measured: baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups
Children's anxiety symptoms
Chinese version of the separation anxiety scale for children
Measured: baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Sep 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka Wai Katherine Lam, Phd, Principal investigator, the polytechnic university of hong kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148922
- Sponsor's protocol ID
- bMHFA_low income family
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mental Health First Aid Program (bMHFA) for Parents to Improve Mental Health Literacy in Low-Income Families: A Three-Arm Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06148922
- Acronym / sponsor ID
- bMHFA_low income family
- Conditions
- Mental Health Issue
- Keywords
- Low-Income families, Parents, Mental Health First Aid (MHFA), brief intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 788 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Randomized Controlled Trial study is to test the effectiveness of the brief Mental Health First Aid Program (bMHFA) for parents to improve Mental Health Literacy in Low-Income families. The main questions it aims to answer are:
- Does the brief MHFA program improve mental health literacy among parents in low-income families?
- Does the brief MHFA program improve mental well-being among children in low-income families?
Participants will be randomly assigned to two groups, intervention and control group.
- Intervention group: attend a 2-hour training program on brief MHFA
- Intervention group: complete a set of questionnaire
- Intervention group: Interviews will be conducted at 12-month follow up
- Control: no need to attend any workshop
- Control: complete a set of questionnaire
Detailed description
The traditional MHFA program covers many more mental disorders. Parents in the intervention group will receive a 2-hour workshop delivered by a registered nurse who has a MHFA training certificate from the Mental Health Association of Hong Kong. The first part includes an introduction that defines mental health and identifies mental health crises and symptoms, risk factors, and impacts. The second part of the workshop involves teaching parents the five key ALGEE techniques. The final part of the workshop concerns application of ALGEE in common types of mental disorders, including depression, anxiety, suicidal thoughts and behaviors, and substance abuse. Interviews will be held after 12-month of the intervention.
While the other group (control) will just have to complete a set of questionnaire, same set also need to complete by the intervention group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Brief Mental Health First Aid WorkshopIntervention group parents will receive a 2-hour workshop delivered by a registered nurse with a MHFA training certificate, in groups of up to 10 parents. Parents will receive a leaflet summarizing the training contents after the workshop. At 1 week and 1-, 3-, and 6-month follow-ups, the trained registered nurse will send a 5-minute reminder video via WhatsApp/WeChat to parents describing the key MHFA techniques. A set of online questionnaires will also be delivered to the parent-child dyads at these follow-ups. |
| Control | No intervention | –The control group will receive no intervention. Only completing the sets of questionnaire. |
| Intervention (Interview) | Other | Other: Semi-structured interviewsParents in the intervention group with the highest and lowest mental health literacy scores will be purposively invited to participate in one-to-one semi-structured interviews to explore their experience of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years or above
- able to speak Cantonese and read Chinese
- parenting at least one child aged 8-13 years
- receiving Comprehensive Social Security Assistance or have a household income less than the half of the median
- Children must be able to speak Cantonese and read Chinese
Key exclusion criteria (1 listed)
- Parents and children with identified cognitive, behavioral, or mental problems will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Mental Health First Aid Workshopa 2-hour workshop delivered by a registered nurse with a MHFA training certificate | Other | Intervention |
| Semi-structured interviewsOne-to-one, face-to-face semi-structured interviews will be conducted by a research assistant. The duration would be around 30 minutes. | Other | Intervention (Interview) |
Primary outcome
Parents' level of mental health literacy
Time frame: 12-month follow-up
Chinese version of the mental health literacy scale
4 secondary outcomes
Parents' level of mental health literacy
Time frame: 1-week and 1-, 3-, and 6- month follow-ups
Children's self-esteem
Time frame: baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups
Children's depressive symptoms
Time frame: baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups
Children's anxiety symptoms
Time frame: baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Wai Katherine Lam, Phd principal investigator
the polytechnic university of hong kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Mental Health First Aid Workshop and Semi-structured interviews in people with Mental Health Issue, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Wai Katherine Lam, Phd (27666420, kw-katherine.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' level of mental health literacy (time frame: 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.