Trial Review

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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] 300203 0
GNT1158429
Universal Trial Number (UTN)
U1111-1246-4079
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 315760 0
Condition category
Condition code
Mental Health 314040 314040 0 0
Depression
Mental Health 314065 314065 0 0
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] 316477 0
Behaviour
Intervention code [2] 316493 0
Prevention
Comparator / control treatment
Participants in the control group will only receive the usual school curriculum.
Control group
Active

Outcomes
Primary outcome [1] 322446 0
Depression, assessed using the Centre for Epidemiologic Studies Depression Scale Revised (CESD-R)
Timepoint [1] 322446 0
Six months post-intervention
Secondary outcome [1] 378573 0
Mental wellbeing, assessed using the Mental Health Continuum Short Form (MHC-SF)
Timepoint [1] 378573 0
Within two weeks post-intervention and six months post-intervention
Secondary outcome [2] 378575 0
Coping self-efficacy, assessed using the Coping Self-Efficacy Scale (CSF)
Timepoint [2] 378575 0
Within two weeks post-intervention and six months post-intervention
Secondary outcome [3] 378576 0
School connectedness, assessed using the School connectedness Scale developed by the National Longitudinal Study of Adolescent Health
Timepoint [3] 378576 0
Within two weeks post-intervention and six months post-intervention
Secondary outcome [4] 378577 0
Anger management, assessed using the Behavioral Anger Response Questionnaire (BARQ)
Timepoint [4] 378577 0
Within two weeks post-intervention and six months post-intervention
Secondary outcome [5] 378699 0
CESD-R score
Timepoint [5] 378699 0
Within two weeks post-intervention.
Secondary outcome [6] 379067 0
Health risk behaviours, assessed using 14 questions derived from the Youth Risk Behavior Survey 2019.
Timepoint [6] 379067 0
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] 22207 0
Viet Nam
State/province [1] 22207 0
Hanoi

Funding & Sponsors
Funding source category [1] 304634 0
Government body
Name [1] 304634 0
Australian National Health and Medical Research Council
Country [1] 304634 0
Australia
Funding source category [2] 304640 0
Government body
Name [2] 304640 0
NAFOSTED
Country [2] 304640 0
Viet Nam
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Road, Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 304932 0
University
Name [1] 304932 0
Queensland University of Technology
Address [1] 304932 0
GPO Box 2434
Brisbane, QLD 4001
Country [1] 304932 0
Australia
Secondary sponsor category [2] 304955 0
University
Name [2] 304955 0
Hanoi University of Public Health
Address [2] 304955 0
1A Duc Thang Road, Duc Thang Ward, North Tu Liem district, Hanoi, Vietnam
Country [2] 304955 0
Viet Nam
Other collaborator category [1] 281129 0
Government body
Name [1] 281129 0
Vietnam Ministry of Education and Training
Address [1] 281129 0
No 35, Dai Co Viet, Ha Noi, Vietnam
Country [1] 281129 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305072 0
Institutional Review Board of the Hanoi University of Public Health
Ethics committee address [1] 305072 0
Ethics committee country [1] 305072 0
Viet Nam
Date submitted for ethics approval [1] 305072 0
15/10/2019
Approval date [1] 305072 0
15/11/2019
Ethics approval number [1] 305072 0
488/2019/YTCC-HD3
Ethics committee name [2] 305092 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 305092 0
Ethics committee country [2] 305092 0
Australia
Date submitted for ethics approval [2] 305092 0
25/11/2019
Approval date [2] 305092 0
Ethics approval number [2] 305092 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99114 0
Dr Thach Tran
Address 99114 0
Global and Women's Health
Public Health and Preventive Medicine, Monash University
Level 4 553 St Kilda Road
Melbourne VIC 3004, Australia
Country 99114 0
Australia
Phone 99114 0
+61 3 9903 0626
Fax 99114 0
Email 99114 0
[email protected]
Contact person for public queries
Name 99115 0
Thach Tran
Address 99115 0
Global and Women's Health
Public Health and Preventive Medicine, Monash University
Level 4 553 St Kilda Road
Melbourne VIC 3004, Australia
Country 99115 0
Australia
Phone 99115 0
+61 3 9903 0626
Fax 99115 0
Email 99115 0
[email protected]
Contact person for scientific queries
Name 99116 0
Thach Tran
Address 99116 0
Global and Women's Health
Public Health and Preventive Medicine, Monash University
Level 4 553 St Kilda Road
Melbourne VIC 3004, Australia
Country 99116 0
Australia
Phone 99116 0
+61 3 9903 0626
Fax 99116 0
Email 99116 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseSchool-based, two-arm, parallel, controlled trial of a culturally adapted resilience intervention to improve adolescent mental health in Vietnam: Study protocol.2020https://dx.doi.org/10.1136/bmjopen-2020-039343
N.B. These documents automatically identified may not have been verified by the study sponsor.