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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000649314
Ethics application status
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Approved
Date submitted
Help: Date submitted
11/05/2026
Date registered
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29/05/2026
Date last updated
Help: Date last updated
29/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/05/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
A Study of a Digital Mental Health Programme for Mental Wellbeing Among Chinese Immigrant Adolescents in New Zealand
Scientific title
Evaluating the Feasibility and Potential Mental Wellbeing Benefits of a Digital Mental Health Programme Among Chinese Immigrant Adolescents in New Zealand: A Quantitative Pilot Study
Additional trial identifiers [1] 317205 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
mental wellbeing 341785 0
stress 341786 0
social isolation 341789 0
cognitive function 341790 0
Condition category
Condition code
Mental Health 337866 337866 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants in the intervention group will use a digital mental health programme, the Smiling Mind mobile application, which is a mindfulness-based programme containing guided breathing and meditation exercises specifically designed for adolescents.

This study is conducted by a PhD candidate from the Department of Psychological Medicine, University of Otago. The researcher has experience in teaching mental health courses at secondary school level, as well as qualitative research experience related to mental health and digital mental health programmes (including Smiling Mind) involving Chinese immigrant adolescents and their parents/guardians.

The intervention will be delivered online through participants’ personal electronic devices, such as smartphones or tablets. During the 3-week intervention period, participants will receive weekly emails outlining the activities to be completed for that week and will be free to arrange their own frequency and duration of use (approximately 15 minutes per day on average). After completing the baseline questionnaires and the post-intervention questionnaires at the end of the 3-week intervention, participants will continue to use the programme freely for an additional 1-month period before completing the follow-up questionnaires.

To improve intervention adherence, weekly reminder emails will be sent to participants or their parents/guardians (according to participant preference), and participants will be asked to submit screenshots of their programme usage at the end of each week.


Participants in the intervention group will use mindfulness-based audio content in the Smiling Mind app intended for teens. As participants in this study are secondary school students in Years 9–13, the intervention will use content categorised as “teens” within the app. This age categorisation has been confirmed through communication with the Smiling Mind team.

The programme content will primarily involve five models (Live Mindfully, Grow Connections, Flexible Thinking, Act Purposefully, and Recharge Your Body), which are intended to support and promote participants’ mental wellbeing. No specialised equipment or additional materials will be required. Participants will access the audio content using their personal electronic devices (e.g., smartphones, tablets, or laptops).

During the 3-week intervention period, participants will receive weekly emails outlining the audio activities to be completed each week. The intervention schedule will be as follows: Week 1: Live Mindfully; Week 2: Grow Connections, Flexible Thinking, Act Purposefully, and part of Recharge Your Body; Week 3: remaining Recharge Your Body content. As the length and content of each model vary, this schedule is intended to minimise participant burden and reduce potential pressure associated with prolonged use, while allowing participants to complete approximately 15 minutes of practice per day on average.
Intervention code [1] 333970 0
Treatment: Other
Intervention code [2] 333971 0
Behaviour
Intervention code [3] 333972 0
Prevention
Description of the comparator or control
Participants in the control group will not use the digital mental health programme (Smiling Mind) during the study period. During the 3-week study period and the following 1-month period, participants will be asked to record their daily relaxation activities and the duration of these activities in written form. Participants will be free to arrange the timing of these activities according to their personal preferences and schedules. Activity records will be submitted to the researcher via email at the end of each week. To improve study adherence, weekly reminder emails will be sent to participants or their parents/guardians (according to participant preference).

This study is conducted by a PhD candidate from the Department of Psychological Medicine, University of Otago. The researcher has experience in teaching mental health courses at secondary school level, as well as qualitative research experience related to mental health and digital mental health programmes (including Smiling Mind) involving Chinese immigrant adolescents and their parents/guardians.

Participants in the control group will not receive access to the intervention during the study period. Following completion of the 3-week study period and the 1-month follow-up assessment, participants in the control group will be granted access to the same Smiling Mind intervention content used in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 345323 0
mindfulness
Timepoint [1] 345323 0
Baseline, immediately after the 3-week intervention period (primary timepoint), and 1-month follow-up.
Primary outcome [2] 345324 0
resilience
Timepoint [2] 345324 0
Baseline, immediately after the 3-week intervention period (primary timepoint), and 1-month follow-up.
Primary outcome [3] 345325 0
mental wellbeing
Timepoint [3] 345325 0
Baseline, immediately after the 3-week intervention period (primary timepoint), and 1-month follow-up.
Secondary outcome [1] 461295 0
stress management
Timepoint [1] 461295 0
Baseline, immediately after the 3-week intervention period, and 1-month follow-up.
Secondary outcome [2] 461296 0
emotional regulation
Timepoint [2] 461296 0
Baseline, immediately after the 3-week intervention period, and 1-month follow-up.
Secondary outcome [3] 461297 0
self-regulation
Timepoint [3] 461297 0
Baseline, immediately after the 3-week intervention period, and 1-month follow-up.
Secondary outcome [4] 461298 0
social relationship
Timepoint [4] 461298 0
Baseline, immediately after the 3-week intervention period, and 1-month follow-up.
Secondary outcome [5] 461299 0
Cognitive flexibility
Timepoint [5] 461299 0
Baseline, immediately after the 3-week intervention period, and 1-month follow-up.

Eligibility
Key inclusion criteria
1. Be Chinese immigrant adolescents currently living in New Zealand.
2. Be enrolled in secondary school education in New Zealand (Years 9–13).
3. Have access to a personal electronic device with internet access (e.g. smartphone or tablet).
4. Be able to understand and communicate in English.
5. Provide informed consent, with parent or guardian consent where required.
6. Only one participant from each family may participate in the study.
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. Have any physical or psychological health conditions that may affect their ability to complete the study procedures safely or independently;
2. Currently participating in another mental health or psychological intervention study.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 100 Chinese immigrant adolescents will be recruited for this study. As a pilot randomised controlled trial, this sample size is expected to provide useful preliminary data regarding the feasibility and potential mental wellbeing benefits of the digital mental health programme, including possible changes in mindfulness, resilience, and mental wellbeing, and to inform sample size estimation for future larger-scale studies.

Data analysis will be conducted using mixed linear regression models. Descriptive statistics will be used to summarise participant demographic characteristics, baseline variables, intervention engagement, adherence, and missing data. Primary analyses will examine the effects of group, time, and group × time interaction on the primary outcomes, including mindfulness, resilience, and mental wellbeing. The model will include three assessment timepoints: baseline, post-intervention, and 1-month follow-up.

Secondary outcomes, including stress management, emotional regulation, self-regulation, cognitive flexibility, and social relationships, will be explored using similar analytical approaches. These variables will also be explored as potential mediators, where appropriate, to further understand the mechanisms through which the digital mental health programme may influence mindfulness, resilience, and mental wellbeing.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/05/2026
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
100
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 28086 0
New Zealand
State/province [1] 28086 0

Funding & Sponsors
Funding source category [1] 321783 0
University
Name [1] 321783 0
Department of Psychological Medicine, University of Otago
Country [1] 321783 0
New Zealand
Primary sponsor type
University
Name
university of otago
Address
Country
New Zealand
Secondary sponsor category [1] 324628 0
None
Name [1] 324628 0
Address [1] 324628 0
Country [1] 324628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320327 0
University of Otago Human Ethics Committee
Ethics committee address [1] 320327 0
Ethics committee country [1] 320327 0
New Zealand
Date submitted for ethics approval [1] 320327 0
17/02/2026
Approval date [1] 320327 0
31/03/2026
Ethics approval number [1] 320327 0

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

Contacts
Principal investigator
Name 150102 0
Ms Tianjiao Zhou
Address 150102 0
Fraser Building, 2nd floor, 464 Cumberland Street, Dunedin 9016 New Zealand
Country 150102 0
New Zealand
Phone 150102 0
+64 27 788 8188
Fax 150102 0
Email 150102 0
[email protected]
Contact person for public queries
Name 150103 0
Tianjiao Zhou
Address 150103 0
Fraser Building, 2nd floor, 464 Cumberland Street, Dunedin 9016 New Zealand
Country 150103 0
New Zealand
Phone 150103 0
+64 27 788 8188
Fax 150103 0
Email 150103 0
[email protected]
Contact person for scientific queries
Name 150104 0
Tianjiao Zhou
Address 150104 0
Fraser Building, 2nd floor, 464 Cumberland Street, Dunedin 9016 New Zealand
Country 150104 0
New Zealand
Phone 150104 0
+64 27 788 8188
Fax 150104 0
Email 150104 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The results of the project may be published and will be available in the University of Otago Library (Dunedin, New Zealand). Any information that could identify participants will be removed or changed. Only group results will be reported, no individual results will be published in any form.

Any data derived from the research will be retained in secure storage for at least five years, as per the University of Otago’s code of conduct research policy. This excludes personal information, which will be securely removed at the completion of the study.



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
No additional documents have been identified.