Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001116910
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
29/10/2020
Date last updated
29/10/2020
Date data sharing statement initially provided
29/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an app to support emotional wellbeing of adolescents.
Scientific title
Quest – Te Whitianga: A single-arm pre-post evaluation of a mobile app to support emotional wellbeing in adolescents.
Secondary ID [1] 302219 0
Nil known
Universal Trial Number (UTN)
U1111-1253-7610
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental wellbeing 318916 0
Anxiety 319258 0
Depression 319259 0
Condition category
Condition code
Mental Health 316896 316896 0 0
Depression
Mental Health 316897 316897 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention ("Quest - Te Whitianga") is a self-administered app available to study participants for download on their personal Android or iOS smart phone, or Chromebook, for self-directed use for the duration of the trial. For this evaluation trial, the treatment period will be approximately two weeks.

The app has been co-designed with Maori and Pasifika young people as part of the HABITs research group. The app consists of six modules, most of which contain at least three ‘levels’, which encourages the user to practise each skill at an increasing level of difficulty. Each module contains interactive activities (e.g. relaxation activity, entries in a gratitude journal, selecting activities to try out, interactive conversations). Module levels generally take less than 5 minutes to complete. The app is highly visual and requires minimum reading. The content is based on evidence-based strategies derived from Cognitive Behavioural Therapy, Interpersonal Therapy (IPT) and positive psychology approaches. The six modules cover the following core concepts:
1. Relaxation and mindfulness: brief slow and controlled breathing exercises
2. Structured problem solving: STEPS (Say what the problem is, Think of solutions, Examine each one, Pick one, See what happens)
3. Activity scheduling: an activity picker exercise designed to motivate the user to do fun, active and new activities to lift mood. Examples include instant activities (e.g. smile, high 5) or fun activities (e.g. shopping, walking the dog, watching a movie, arts activities, relaxation activities).
4. Gratitude Journal: each time a user logs into the app s/he is asked to name three things they are grateful that day.
5. Interpersonal skills; Communication, assertiveness and staying in control of strong emotions
6. How thoughts influence emotions and how to deal with negative thoughts through ‘accept, distract, reframe’ methods.

In the first instance, participants are introduced to the first level of each island (activity) sequentially (in the order: gratitude journal, relaxation, activity scheduling, thoughts and emotions, problem solving, interpersonal skills). Thereafter, participants are able to progress and continue at their discretion. There are no directions given to the participants regarding frequency or duration of use; use of the app is completely at the participants discretion.

Adherence to the intervention will be assessed using app usage metrics including duration and pattern of use as well as completion of modules and activities in the app. The app is linked through secure individual user accounts to the HABITs IT platform.

The "Quest - Te Whitianga" app will be used in an open-label fashion in this open trial.
Intervention code [1] 318511 0
Treatment: Other
Intervention code [2] 318730 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324998 0
Changes in self-reported wellbeing after completion of treatment compared with baseline using the WHO (Five) Wellbeing Index (WHO-5).
Timepoint [1] 324998 0
Baseline. Post-intervention - 2 weeks after intervention commencement.
Secondary outcome [1] 386511 0
Change in self-reported frequency of use of mental health coping skills introduced in the app - assessed using a brief rating scale developed for this trial.
Timepoint [1] 386511 0
Post-intervention - 2 weeks after intervention commencement.
Secondary outcome [2] 386513 0
Acceptability: App ratings from young people using a brief app rating scale developed for this trial. Participants will also be asked to rate their preferred module within the app and provide a brief review.
Timepoint [2] 386513 0
Participants are invited to complete the app rating scale within 24 hours of their first use of the app. They can complete the app rating at any time up during the intervention period and up to 21 days after commencement of the intervention.
Secondary outcome [3] 386515 0
Total time spent using app (seconds)
Timepoint [3] 386515 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as total time spent.
Secondary outcome [4] 386516 0
Number of times the app is accessed during the intervention period
Timepoint [4] 386516 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as number of times the app is accessed.
Secondary outcome [5] 386517 0
Average duration of each app session (seconds)
Timepoint [5] 386517 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as session duration. The raw data will subsequently be analysed to calculate average duration.
Secondary outcome [6] 386518 0
Number of levels of each module completed
Timepoint [6] 386518 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as number of module levels completed.
Secondary outcome [7] 386519 0
Estimate of changes in self-reported stress level using within-app momentary assessments. Momentary assessments are simple visual sliding scale assessments scheduled immediately before and after completion of the gratitude journal activities. This within app likert scale (quantified on a scale from 0-1) collects information on perceived stress. Through the secure connection to our HABITS IT server, this information is passively collected from the app when connected to wifi. We will analyse these data to gauge whether there is an immediate improvement after using a module and/or a pattern of improvement over the course of the intervention period.
Timepoint [7] 386519 0
Evaluated every time participants start and finish the gratitude module.
Secondary outcome [8] 386520 0
Estimate of changes in self-reported life satisfaction using within-app momentary assessments. Momentary assessments are simple visual sliding scale assessments scheduled immediately before and after completion of the gratitude journal module activities. This within app likert scale (quantified on a scale from 0-1) collects information on perceived satisfaction with life. Through the secure connection to our HABITS IT server, this information is passively collected from the app when connected to wifi. We will analyse these data to gauge whether there is an immediate improvement after using a module and/or a pattern of improvement over the course of the intervention period.
Timepoint [8] 386520 0
Evaluated every time participants start and finish the gratitude module.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if:
•They are aged 11-16 years of age (on the day of consent);
•They have access to a smart phone, tablet or Chromebook at home (Android, iOS or Chromebook);
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As this is a universal early prevention trial, there are no exclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Allowing initially for an attrition of approximately 40% and if a minimum of 100 participants are recruited for this study, we would anticipate 60 completing post intervention outcome measures. This sample size will ensure there is 80% power to show moderate effect sizes (0.50 - 0.60) as statistically significant (2-tailed alpha=0.05). Effect sizes of this magnitude would equate to differential changes of about 6 points on the WHO-5. This difference is less that that considered as a minimal clinically significant benefit for the WHO-5 scale from the intervention but is powered to detect a more likely increment for an intervention of this nature based on our existing data on this intervention. We will carry out an interim check of sample attrition (completion of baseline and post-intervention WHO-5) after recruitment and completion of follow-up of the first 30 participants. If study dropout is higher than expected, we will amend our study protocol to reflect the additional participant recruitment required.

Baseline data will be summarised using standard descriptive statistics including means, medians, ranges and standard deviations and frequencies and percentages, as appropriate.
Descriptive data, include means and standard deviations, will be used to describe responses to the primary outcome wellbeing measure, the secondary coping skills checklist, and the within app Likert scales, with changes over time estimated by calculating effect sizes. Changes in the wellbeing measures from baseline to post-intervention and follow-up will be analysed with paired comparisons using the paired t-test or Wilcoxon signed rank tests (if the data is not normally distributed). A two-tailed p-value <0.05 will be taken to indicate statistical significance.
Descriptive summaries including means, medians, ranges and standard deviations and frequencies and percentages will be used to describe app usage behaviour and responses provided in the app rating scale. These descriptive summaries will be estimated for the number of times the app is accessed, the average time spent on each module and in each level within the module, adherence over the 2 weeks and the stability of the platform and the app.
The app rating and usage data will be summarised for the all those completing these scales and additionally will be summarised for Maori/Pasifika and non-Maori, non-Pasifika participants and compared between these two groups. These comparisons will be made using non-parametric Mann-Whitney-U tests and chi-square tests, as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2020
Actual
Date of last participant enrolment
Anticipated
31/05/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 22916 0
New Zealand
State/province [1] 22916 0

Funding & Sponsors
Funding source category [1] 306640 0
Government body
Name [1] 306640 0
Ministry of Business, Innovation and Employment
Country [1] 306640 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Research Office
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 307191 0
None
Name [1] 307191 0
Address [1] 307191 0
Country [1] 307191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306825 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 306825 0
Ethics committee country [1] 306825 0
New Zealand
Date submitted for ethics approval [1] 306825 0
18/06/2020
Approval date [1] 306825 0
26/08/2020
Ethics approval number [1] 306825 0
20/NTB/140

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

Contacts
Principal investigator
Name 105142 0
Dr Karolina Stasiak
Address 105142 0
Department of Psychological Medicine University of Auckland Private Bag 92019 Auckland 1142
Country 105142 0
New Zealand
Phone 105142 0
+64 9 923 3890
Fax 105142 0
Email 105142 0
[email protected]
Contact person for public queries
Name 105143 0
Sarah Hopkins
Address 105143 0
Department of Psychological Medicine University of Auckland Private Bag 92019 Auckland 1142
Country 105143 0
New Zealand
Phone 105143 0
+64 9 923 2015
Fax 105143 0
Email 105143 0
[email protected]
Contact person for scientific queries
Name 105144 0
Karolina Stasiak
Address 105144 0
Department of Psychological Medicine University of Auckland Private Bag 92019 Auckland 1142
Country 105144 0
New Zealand
Phone 105144 0
+64 9 923 3890
Fax 105144 0
Email 105144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A formal data sharing plan for this research has be considered in the context of prioritising cultural sensitivity of indigenous and minority populations and the sensitivity of data on minors participating in this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9028Study protocol  [email protected]
9029Ethical approval  [email protected]



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.