NCT06148922

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
788

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

November 20, 2023

Last Update Submit

November 20, 2023

Conditions

Mental Health Issue

Keywords

Low-Income familiesParentsMental Health First Aid (MHFA)brief intervention

Outcome Measures

Primary Outcomes (1)

  • Parents' level of mental health literacy

    Chinese version of the mental health literacy scale

    12-month follow-up

Secondary Outcomes (4)

  • Parents' level of mental health literacy

    1-week and 1-, 3-, and 6- month follow-ups

  • Children's self-esteem

    baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups

  • Children's depressive symptoms

    baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups

  • Children's anxiety symptoms

    baseline and at the 1-week and 1-, 3-, 6-, and 12-month follow-ups

Study Arms (3)

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.

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.

Other: Semi-structured interviews

Interventions

Brief Mental Health First Aid WorkshopOTHER

a 2-hour workshop delivered by a registered nurse with a MHFA training certificate

Intervention
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.

Intervention (Interview)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The polytechnic university of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Ka Wai Katherine Lam, Phd

    the polytechnic university of hong kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Wai Katherine Lam, Phd

CONTACT

27666420kw-katherine.lam@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

September 1, 2021

Primary Completion

April 30, 2024

Study Completion

April 30, 2026

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

HK(1)