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

November 20, 2023 updated by: The Hong Kong Polytechnic University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

788

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Polytechnic University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Parents and children with identified cognitive, behavioral, or mental problems will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Other: Brief Mental Health First Aid Workshop
a 2-hour workshop delivered by a registered nurse with a MHFA training certificate
No Intervention: Control
The control group will receive no intervention. Only completing the sets of questionnaire.
Other: Intervention (Interview)
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.
Other: Semi-structured interviews
One-to-one, face-to-face semi-structured interviews will be conducted by a research assistant. The duration would be around 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' level of mental health literacy
Time Frame: 12-month follow-up
Chinese version of the mental health literacy scale
12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' level of mental health literacy
Time Frame: 1-week and 1-, 3-, and 6- month follow-ups
Chinese version of the mental health literacy scale
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
Chinese version of the Rosenberg Self-Esteem Scale
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
Chinese version of the Center for Epidemiological Studies Depression Scale for Children
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
Chinese version of the separation anxiety scale for children
baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Ka Wai Katherine Lam, Phd, The Polytechnic University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • bMHFA_low income family

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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