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Trial registered on ANZCTR

Registration number

ACTRN12620000088943

Ethics application status

Approved

Date submitted

14/01/2020

Date registered

3/02/2020

Date last updated

21/10/2021

Date data sharing statement initially provided

3/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Culturally-adapted Resourceful Adolescent Program to improve the mental health of adolescents in Vietnam

Scientific title

Addressing an unrecognised public health problem in Vietnam: a clustered randomised controlled trial of the culturally adapted Resourceful Adolescent Program to improve adolescent mental health

Secondary ID [1]

GNT1158429

Universal Trial Number (UTN)

U1111-1246-4079

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mental health

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention name - Happy House

The Resourceful Adolescent Program for adolescents (RAP-A) is a school-based program designed to promote factors that protect against adolescent depression and other mental health problems. It is a strengths-based program, focussed on developing strengths rather than on the pathology. The intervention for this trial is Happy House, the culturally-adapted RAP-A for adolescents in Vietnam. Happy House will be delivered through six workshop-style sessions, with a focus on the main components of RAP-A: personal strengths, managing stress, cognitive style, problem solving, support networks and interpersonal relationships.

The intervention is targeted at Year 10 students at selected schools in Hanoi, Vietnam. It is in addition to the usual school curriculum. The sessions will be delivered by core facilitators: teachers from the selected schools and members of the research team in Vietnam. The RAP authors will provide a training course in English for the research team. Then, the research team will train the core facilitators about the RAP-A principles and how to facilitate the sessions in Vietnamese. Both training courses will run for 2 days, ~8 hours/day, and the training will be conducted roughly 3 weeks before the intervention will begin. Training materials will be designed and developed specifically for this study. The core facilitators will be provided with a Group Leader’s Manual, which has detailed information about how to run each session, as well as all materials and equipment for the sessions (e.g. paper, pens, visual aids, videos, etc.). The Group Leader's Manual is based on the manual developed by the original RAP authors (http://www.rap.qut.edu.au/), but has been adapted for this study and cultural setting.

Year 10 classes in Vietnam typically have 35-45 students. In each class, students participating in the intervention will be split into two groups. Thus, the intervention will be run in groups of ~15-20 students. Happy House involves 6 x 90-minute sessions, once a week for six weeks. The sessions are delivered face-to-face by the core facilitators, in classrooms at the selected schools. Participants will receive a Student Workbook to use during the sessions. Similarly to the Group Leader's Manual, the Student Workbook is based on the manual developed by the original RAP authors (http://www.rap.qut.edu.au/), but has been adapted for this study and cultural setting. Between each session, students will be sent text messages, to reinforce key parts of the program.

Adherence will be assessed by the core facilitators, who will record the participants’ attendance at each session. Fidelity will be reported by the research team if any changes are made when implementing the protocol.

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

Participants in the control group will only receive the usual school curriculum.

Control group

Active

Outcomes

Primary outcome [1]

Depression, assessed using the Centre for Epidemiologic Studies Depression Scale Revised (CESD-R)

Timepoint [1]

Six months post-intervention

Secondary outcome [1]

Mental wellbeing, assessed using the Mental Health Continuum Short Form (MHC-SF)

Timepoint [1]

Within two weeks post-intervention and six months post-intervention

Secondary outcome [2]

Coping self-efficacy, assessed using the Coping Self-Efficacy Scale (CSF)

Timepoint [2]

Within two weeks post-intervention and six months post-intervention

Secondary outcome [3]

School connectedness, assessed using the School connectedness Scale developed by the National Longitudinal Study of Adolescent Health

Timepoint [3]

Within two weeks post-intervention and six months post-intervention

Secondary outcome [4]

Anger management, assessed using the Behavioral Anger Response Questionnaire (BARQ)

Timepoint [4]

Within two weeks post-intervention and six months post-intervention

Secondary outcome [5]

CESD-R score

Timepoint [5]

Within two weeks post-intervention.

Secondary outcome [6]

Health risk behaviours, assessed using 14 questions derived from the Youth Risk Behavior Survey 2019.

Timepoint [6]

Within two weeks post-intervention and six months post-intervention

Eligibility

Key inclusion criteria

Grade 10 student
Studying in a selected class

Minimum age

14 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Students whose parents do not give permission for them to participate.
Students who do not wish to participate.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

An independent statistician randomly assigned schools to the intervention and control arms, using number containers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sequence generation was done by simple randomisation using a randomisation table created using computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size and cluster number were calculated in Stata V16. 1,004 adolescents (each study arm: 502 adolescents) are needed to detect a difference in the primary outcome (CESD-R score => 16) of 41% in the control group and 31% in the intervention group (power of 90%, significance level of 0.05).

Descriptive analyses will be conducted to describe the participants' characteristics. Differences in the primary and secondary outcomes between the intervention and control arms will be estimated using individual-level analyses, adjusting for clustering. Mixed-effect logistic regression (primary outcome) and mixed-effect linear and logistic regression models (secondary outcomes) will be conducted to estimate the effects of the intervention on the outcomes. Covariates and prognostic factors will be taken into account, and random effects for class and school and a fixed effect for the trial arm will be incorporated.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2020

Actual

6/10/2020

Date of last participant enrolment

Anticipated

31/03/2020

Actual

24/10/2020

Date of last data collection

Anticipated

31/12/2020

Actual

22/05/2021

Sample size

Target

1204

Accrual to date

Final

1084

Recruitment outside Australia

Country [1]

Viet Nam

State/province [1]

Hanoi

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian National Health and Medical Research Council

Address [1]

414 La Trobe Street, Melbourne, VIC, 3000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NAFOSTED

Address [2]

4th floor, 39 Tran Hung Dao, Hang Bai, Hoan Kiem, TP. Ha Noi.

Country [2]

Viet Nam

Primary sponsor type

University

Name

Monash University

Address

553 St Kilda Road, Melbourne, VIC, 3004

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Queensland University of Technology

Address [1]

GPO Box 2434
Brisbane, QLD 4001

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

Hanoi University of Public Health

Address [2]

1A Duc Thang Road, Duc Thang Ward, North Tu Liem district, Hanoi, Vietnam

Country [2]

Viet Nam

Other collaborator category [1]

Government body

Name [1]

Vietnam Ministry of Education and Training

Address [1]

No 35, Dai Co Viet, Ha Noi, Vietnam

Country [1]

Viet Nam

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board of the Hanoi University of Public Health

Ethics committee address [1]

1A Duc Thang Road, Duc Thang Ward, North Tu Liem district, Hanoi, Vietnam

Ethics committee country [1]

Viet Nam

Date submitted for ethics approval [1]

15/10/2019

Approval date [1]

15/11/2019

Ethics approval number [1]

488/2019/YTCC-HD3

Ethics committee name [2]

Monash University Human Research Ethics Committee

Ethics committee address [2]

Monash University, Wellington Road, Clayton, VIC, 3800

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

25/11/2019

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

Mental health problems are more prevalent among adolescents in low- and lower-middle income countries (LALMIC), where most of the world’s young people live, than in high-income countries. As yet, there is little recognition of mental health, and few mental health programs or services exist for adolescents in these settings. 
We have demonstrated that in Vietnam, one in seven young people attending secondary school had experienced suicidal thoughts or plans in the previous year, over a third (34%) had experienced feelings of helplessness and hopelessness, and about three quarters (74%) had engaged in a health risk behaviour. Health risk behaviours were significantly more common among those with mental health problems. We have also shown that exposure to multiple forms of violence is the main risk factor for symptoms of common mental disorders, suicidal ideas, poor health-related quality of life and risk taking behaviours among adolescents in Vietnam, but is unrecognised and under-addressed. There is an urgent need for an evidence-based, comprehensive, universal mental health intervention to address the high prevalence of mental health problems among young people in Vietnam. 
The study aims to improve the mental health of adolescents in Vietnam. It is predicted that the Resourceful Adolescent Program for adolescents (RAP-A) adapted to Vietnam (renamed Happy House) will reduce mental health problems among adolescents in Vietnam. 
Grade 10 students from eight randomly chosen schools in Hanoi, Vietnam will be invited to participate. Four schools will be allocated to the intervention (Happy House), and four schools will be the controls (attend normal classes). The Happy House program involves six 90-minute sessions run by core facilitators. The program focuses on six core components: personal strengths, managing stress, cognitive style, problem solving, support networks and interpersonal relationships. 
Participants will complete a questionnaire before the intervention, two weeks after the intervention and then six months after that. Participants in the control group will complete the same questionnaires. The main outcome tested will be a depression score, measured using the Centre for Epidemiologic Studies Depression Scale Revised (CESD-R). We will also look at mental wellbeing, coping self-efficacy, school connectedness and anger management, and health risk behaviors.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Thach Tran

Address

Global and Women's Health
Public Health and Preventive Medicine, Monash University
Level 4 553 St Kilda Road
Melbourne VIC 3004, Australia

Country

Australia

Phone

+61 3 9903 0626

Fax

thach.tran@monash.edu

Contact person for public queries

Name

Thach Tran

Address

Global and Women's Health
Public Health and Preventive Medicine, Monash University
Level 4 553 St Kilda Road
Melbourne VIC 3004, Australia

Country

Australia

Phone

+61 3 9903 0626

Fax

thach.tran@monash.edu

Contact person for scientific queries

Name

Thach Tran

Address

Global and Women's Health
Public Health and Preventive Medicine, Monash University
Level 4 553 St Kilda Road
Melbourne VIC 3004, Australia

Country

Australia

Phone

+61 3 9903 0626

Fax

thach.tran@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All individual participant data collected during the trial will be shared after de-identification

When will data be available (start and end dates)?

Data will be available from 31/12/2021, with no determined end date

Available to whom?

Anyone who wishes to access the data will be able to

Available for what types of analyses?

The data will be available for analyses of any purpose

How or where can data be obtained?

Data will be available via the following link:
https://monash.figshare.com/

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	School-based, two-arm, parallel, controlled trial of a culturally adapted resilience intervention to improve adolescent mental health in Vietnam: Study protocol.	2020	https://dx.doi.org/10.1136/bmjopen-2020-039343

N.B. These documents automatically identified may not have been verified by the study sponsor.

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