Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001403729p
Ethics application status
Submitted, not yet approved
Date submitted
5/10/2022
Date registered
2/11/2022
Date last updated
2/11/2022
Date data sharing statement initially provided
2/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a well-being application with New Zealand high school students
Scientific title
Whitu For school, a Well-being App for New Zealand High School Students: Randomised Controlled Trial
Secondary ID [1] 308093 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 327787 0
Mental health 327788 0
Condition category
Condition code
Mental Health 324859 324859 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Whitu For School app is designed to help rangatahi learn evidence-based strategies for maintaining and improving their well-being.

It includes seven modules that can be trialled over a week or at a user’s own pace: 1. Feel (recognising emotions); 2. Relax (relaxation techniques); 3. Be kind to yourself (self-compassion exercises); 4. Be thankful (gratitude exercises); 5. Connect (increasing social support); 6. Look after you body (information on diet, exercise, sleep); and 7. Goal setting (setting Specific, Measurable, Achievable, Realistic, Time-bound (SMART) goals).

Modules contain cartoon-based explanations and exercises, take 5-15 minutes each and can be completed in a flexible manner according to user preference.

Users are encouraged to explore this broad range of strategies, discover the ones that best work for them and keep using them over time. Although there is no expected frequency of use, badge rewards and daily notifications encourage app completion and practice of preferred strategies.

Data entered by users are stored on their devices in an unencrypted SQLite database and can be safely removed at any time by deleting the app
Intervention code [1] 324542 0
Treatment: Other
Comparator / control treatment
Waitlist control

Participants in the waitlist group will be provided with access to the Whitu For School app following trial completion (at 3 months).
Control group
Active

Outcomes
Primary outcome [1] 332676 0
Emotional well-being will be measured using the 5-item World Health Organisation Well-Being Index (WHO-5)
Timepoint [1] 332676 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement
Primary outcome [2] 332775 0
Mental wellbeing 7-item will be assessed using the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Timepoint [2] 332775 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement
Secondary outcome [1] 414337 0
Depression will be assessed using the 20-item Center for Epidemiological Studies Depression Scale (CES-D)
Timepoint [1] 414337 0
Baseline, 1 month (primary timepoint), 3 months post-commencement
Secondary outcome [2] 414338 0
User engagement will be assessed using the App Subjective Quality subscale and the Perceived Impact subscale of the end-user version of the User Mobile Application Rating Scale (uMARS)
Timepoint [2] 414338 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement
Secondary outcome [3] 414679 0
Anxiety will be assessed using the 7-item Generalised Anxiety Disorder Scale (GAD-7)
Timepoint [3] 414679 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement
Secondary outcome [4] 414680 0
Self-compassion will be assessed using the Self-Compassion Scale-Short Form (SCS-SF)
Timepoint [4] 414680 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement
Secondary outcome [5] 414681 0
Stress will be assessed using the 10-item Perceived Stress Scale (PSS-10)
Timepoint [5] 414681 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement
Secondary outcome [6] 414682 0
Sleep quality will be assessed using the Single-item Sleep Quality Scale (SQS)
Timepoint [6] 414682 0
Baseline, 1 month (primary timepjoint), 3 months post-commencement

Eligibility
Key inclusion criteria
Eligible participants will be high school students aged between 13-15 years, who have a smartphone (Android or iPhone), who are of any ethnicity, and who are fluent in English or Te Reo Maori). Purposive sampling will be undertaken to ensure that 33% of participants are Maori. To improve equity, students who do not have a smartphone, but wish to take part, will be loaned one for the duration of the study.
Minimum age
13 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be excluded if they are not aged 13-15 years and are unwilling to provide paired parental consent/individual assent.

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)
Neither participants nor researchers will be blind to treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Electronic randomisation via RedCAP
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised using means and standard deviations or numbers and percentages. Repeated measures ANOVA will be used with linear mixed models to include participants with data at only one or two of the three time points. The main analysis aims to determine whether changes in psychological outcomes are the result of the interaction between the intervention group and time, with post-hoc tests to assess pairwise comparisons of groups at each time point and within-group changes over time. Cohens f2 will be calculated as a measure of effect size for the group by time interaction.53 Primary comparisons of interest are between-group differences at 4 weeks and 3 months, with results presented as marginal mean differences, 95% CIs and p-values. Results will be analysed on an intention-to-treat basis. Quantitative data will be analysed using Strata® software version 17, with statistical significance set at p<0.05. Qualitative feedback during phase 2 and 3 will be independently extracted and analysed by two authors (HT and AS) using a general inductive approach.54 Any coding discrepancies will be resolved by consensus.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2023
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 25025 0
New Zealand
State/province [1] 25025 0

Funding & Sponsors
Funding source category [1] 312349 0
Charities/Societies/Foundations
Name [1] 312349 0
Auckland Medical Research Foundation
Country [1] 312349 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Auckland Medical Research Foundation
Address
81 Grafton Road, Grafton, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 313919 0
None
Name [1] 313919 0
Address [1] 313919 0
Country [1] 313919 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311712 0
NZ Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 311712 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 311712 0
New Zealand
Date submitted for ethics approval [1] 311712 0
10/10/2022
Approval date [1] 311712 0
Ethics approval number [1] 311712 0

Summary
Brief summary
The rangatahi (young people) of Aotearoa (New Zealand) are experiencing significant and increasing challenges to their well-being, with 23% of high school students reporting significant depressive symptoms; 6% percent attempting suicide; and 19% having difficulties accessing mental health support each year. In recent years, rapidly evolving smart technology has led to the development of a range of digital mental health interventions including information-oriented websites for learning about stress management, game-based online therapies for common mental health problems and self-help applications with which to improve well-being. During the early phase of the COVID-19 pandemic, our team was concerned about international trends in psychological issues impacting rangatahi in Aotearoa as social distancing and lockdowns commenced and developed an evidence-based well-being app called 'Whitu - seven ways in seven days'. The app includes cognitive behaviour therapy, mindfulness and gratitude paradigms. During an open trial and randomised controlled trial, this app was shown to improve wellbeing, self-compassion, sleep, stress levels and depression in users. We are now planning on adapting the app for high school students and wish to test the efficacy and acceptability of app with 13-15 year olds via a further randomised controlled trial. We will recruit 90 participants from two NZ high schools and randomise them to an intervention group or waitlist group. We will collect wellbeing-related outcome measures at baseline, 1 month and 3 months.
Trial website
Trial related presentations / publications
Public notes
This trial follows an (unpublished) qualitative study conducted earlier this year (2022) with New Zealand high school students.

Contacts
Principal investigator
Name 122094 0
Dr Hiran Thabrew
Address 122094 0
Department of Psychological Medicine, School of Medicine, University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country 122094 0
New Zealand
Phone 122094 0
+64 21 402 055
Fax 122094 0
Email 122094 0
h.thabrew@auckland.ac.nz
Contact person for public queries
Name 122095 0
Dr Hiran Thabrew
Address 122095 0
Department of Psychological Medicine, School of Medicine, University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country 122095 0
New Zealand
Phone 122095 0
+64 21 402 055
Fax 122095 0
Email 122095 0
h.thabrew@auckland.ac.nz
Contact person for scientific queries
Name 122096 0
Dr Hiran Thabrew
Address 122096 0
Department of Psychological Medicine, School of Medicine, University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country 122096 0
New Zealand
Phone 122096 0
+64 21 402 055
Fax 122096 0
Email 122096 0
h.thabrew@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data from questionnaires/measures may be anonymised prior to being made available for future research. Anonymised data will be irreversibly stripped of the unique participant code and any other identifiers. Participants will be informed that anonymous/anonymised data is unable to be accessed, corrected, or withdrawn; and that return of individual results will not be possible.
When will data be available (start and end dates)?
De-identified data will be available on request for 10 years following the commencement of the trial.
Available to whom?
Data will be available to future researchers
Available for what types of analyses?
Data will be available for all types of analyses
How or where can data be obtained?
Data will be made available upon request and the process will involve emailing the principal investigator Hiran Thabrew at h.thabrew@auckland.ac.nz


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.