NCT06753344

Brief Summary

There is a critical gap in access to mental health promotion, prevention and support among youth worldwide, especially in low and middle-income countries like Vietnam. The Y-PRIME Study aims to respond to this gap by co-designing with Vietnamese youth a mobile app that delivers life skills and self-management skills intervention to promote mental well-being in grade 10 Vietnamese students. Working with the Vietnam Youth Advisory Council (V-YAC) to adapt and co-design the intervention and app ensure that the intervention will be culturally appropriate and relevant to Vietnamese youth. The goal of the current phase is to test this intervention with grade 10 students across three provinces (Hanoi, Thai Binh, and Hung Yen) to assess:

  1. 1.Whether the app helps to improve mental well-being and resilience among youth in Vietnam and helps to reduce factors that might increase the risk of poor mental well-being, like stress related to school and other pressures
  2. 2.Whether the app can be delivered in Vietnamese schools
  3. 3.Whether Vietnamese youth and school staff think the app is appropriate and appealing for youth in order to scale-up the model across the country

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jan 2025

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jan 2025Mar 2028

First Submitted

Initial submission to the registry

December 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

December 17, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

digital mental healthyouthLMICwell-beingresiliencelife skills education

Outcome Measures

Primary Outcomes (1)

  • Warwick Edinburg Mental Wellbeing Scale (WEMWBS)

    The Warwick Edinburg Mental Wellbeing Scale (WEMWBS), a 14-item scale that uses positively worded statements to assess feeling and functioning aspects of mental well-being in the general population. Each item is rated on a 5-point Likert scale (1 = none of the time and 5 = all of the time). Higher sum scores indicate higher positive mental wellbeing.

    baseline, 6 months, 12 months

Secondary Outcomes (9)

  • Positive Childhood Experience (PCE)

    baseline, 6 months, 12 months

  • Depression Anxiety and Stress Scale - Youth version (DASS -Y)

    baseline, 6 months, 12 months

  • Brief Inventory of Thriving (BIT)

    baseline, 6 months, 12 months

  • Connor-Davidson Resilience Scale - VN

    baseline, 6 months, 12 months

  • Internet Addiction Test - Short version (S-IAT)

    baseline, 6 months, 12 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The experimental arm will use our app-based intervention \[name TBD\] at their own pace for 1 year. The app will introduce and teach six life and self-management skills to promote general mental well-being and resilience among Vietnamese youth. During the year, they will complete the outcome survey at baseline, 6 months, and 12 months marks. App data will be collected.

Behavioral: Intervention app

Control group

NO INTERVENTION

The no intervention arm will complete the outcome survey at baseline, 6 months, and 12 months. After 12 months, they will gain access to the intervention app (at the same time as the experimental group) but no app data will be collected.

Interventions

The app-based intervention, co-designed with the V-YAC, aims to introduce life skills and self-management skills to promote general mental well-being and resilience among Vietnamese youth. With this app, youth users will have a fun and safe space to learn and practice six life skills areas (Problem-solving, Social Media and Well-being, Communication and Interpersonal Skills, Realistic Thinking, Coping with Emotions and Stress, and Goal Setting). Lessons (in the form of short texts) and activities (ex. multiple choice activities, blank worksheets, reflection questions) were adapted from evidence-based interventions developed in other contexts to be culturally appropriate to the Vietnamese youth context. Youth users are free to explore the app at their own pace. Gamification features will also allow youth users to collect points in the app for completing each lesson, activity, or challenge.

Intervention Group

Eligibility Criteria

Age15 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in grade 10 of participating secondary schools
  • Have access to a smartphone
  • Provided informed assent to participate
  • Parent of participant provided informed consent for their child to participate

You may not qualify if:

  • Not in grade 10
  • Not enrolled in participating secondary schools
  • Not have access to a smartphone
  • Not provided assent
  • Parent did not provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Population, Health, and Development, Vietnam

Hanoi, 117222, Vietnam

RECRUITING

Related Publications (1)

  • Murphy JK, Nguyen VC, Linh DT, Xie H, Tran TH, Barbic SP, Chau LW, Samji H, Minas H, Nguyen MV, Obrzut A, O'Neil J, Michalak EE, Lam RW. Promoting mental well-being among secondary school students in Vietnam using the Y-MIND app: A protocol for a hybrid type 2, sequence pre-post, quasi-experimental study. PLoS One. 2025 Oct 7;20(10):e0332875. doi: 10.1371/journal.pone.0332875. eCollection 2025.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Raymond Lam, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Jill Murphy, PhD

    St. Francis Xavier University

    PRINCIPAL INVESTIGATOR
  • Nguyen Vu, MD

    Institute of Population Health and Development

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Murphy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 31, 2024

Study Start

January 10, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations