Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001195145
Ethics application status
Approved
Date submitted
22/07/2019
Date registered
27/08/2019
Date last updated
27/08/2019
Date data sharing statement initially provided
27/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the uptake of a mobile phone application (app) to support youth wellbeing and resilience.
Scientific title
Understanding the uptake of “Quest – Te Whitianga”: a HABITs app to support the emotional wellbeing of adolescents.
Secondary ID [1] 298788 0
Nil known
Universal Trial Number (UTN)
U1111-1237-2936
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 313740 0
Depression 313741 0
Condition category
Condition code
Mental Health 312141 312141 0 0
Anxiety
Mental Health 312142 312142 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention ("Quest - Te Whitianga") is an 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. App access is administered online and not facilitated face-to-face. For this uptake trial, the treatment period will be approximately eight weeks.

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
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.

Adherence to the intervention will be described 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 by participants. App usage is entirely at participants discretion.
Intervention code [1] 315075 0
Prevention
Intervention code [2] 315229 0
Treatment: Other
Intervention code [3] 315230 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320803 0
The primary outcome measure is the number of participants who download and login to the Quest – Te Whitianga app at least once (app uptake). This outcome is assessed by accessing standard website and app analytics.
Timepoint [1] 320803 0
Download and login will be measured after access to the app for eight weeks (download/login can happen only once for each participant during this time).
Secondary outcome [1] 372896 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 [1] 372896 0
Post-intervention - at least 2 weeks after intervention commencement.
Secondary outcome [2] 372898 0
Total time spent using app (seconds)
Timepoint [2] 372898 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 [3] 372899 0
Number of times the app is accessed during the intervention period
Timepoint [3] 372899 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 [4] 372900 0
Average duration of each app session (seconds)
Timepoint [4] 372900 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 [5] 372901 0
Number of levels of each module completed
Timepoint [5] 372901 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 [6] 372902 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 [6] 372902 0
Update Evaluated every time participants start and finish the relaxation module.
Secondary outcome [7] 372903 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 [7] 372903 0
Evaluated every time participants start and finish the gratitude module.
Secondary outcome [8] 372904 0
Number of unique visits to our study webpage, assessed by accessing standard website analytics
Timepoint [8] 372904 0
At study close
Secondary outcome [9] 372905 0
Number of clicks through from study webpage to registration on the HABITs portal, assessed by accessing standard website analytics
Timepoint [9] 372905 0
At study close
Secondary outcome [10] 372906 0
Number of complete registrations on the HABITs portal, assessed via electronic monitoring and analytics from our online platform.
Timepoint [10] 372906 0
At study close

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if:
•They are aged 12-22 years of age (on the day of consent);
•They have been given a link to the Quest – Te Whitianga study webpage through links with a partner school or organisation; and
•They have access to a smart phone, tablet or Chromebook at home (Android, iOS or Chromebook);
Minimum age
12 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
9/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 21707 0
New Zealand
State/province [1] 21707 0

Funding & Sponsors
Funding source category [1] 303347 0
Government body
Name [1] 303347 0
Ministry of Business, Innovation and Employment
Country [1] 303347 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] 303375 0
None
Name [1] 303375 0
Address [1] 303375 0
Country [1] 303375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303875 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 303875 0
Ethics committee country [1] 303875 0
New Zealand
Date submitted for ethics approval [1] 303875 0
Approval date [1] 303875 0
13/05/2019
Ethics approval number [1] 303875 0
Ref. 022895

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

Contacts
Principal investigator
Name 95094 0
Dr Karolina Stasiak
Address 95094 0
Department of Psychological Medicine University of Auckland Private Bag 92019 Auckland 1142
Country 95094 0
New Zealand
Phone 95094 0
+64 9 923 3890
Fax 95094 0
Email 95094 0
k.stasiak@auckland.ac.nz
Contact person for public queries
Name 95095 0
Sarah Hopkins
Address 95095 0
Department of Psychological Medicine University of Auckland Private Bag 92019 Auckland 1142
Country 95095 0
New Zealand
Phone 95095 0
+64 9 923 2015
Fax 95095 0
Email 95095 0
s.hopkins@auckland.ac.nz
Contact person for scientific queries
Name 95096 0
Karolina Stasiak
Address 95096 0
Department of Psychological Medicine University of Auckland Private Bag 92019 Auckland 1142
Country 95096 0
New Zealand
Phone 95096 0
+64 9 923 3890
Fax 95096 0
Email 95096 0
k.stasiak@auckland.ac.nz

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 must 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
3328Study protocol  s.hopkins@auckland.ac.nz
3329Ethical approval    378009-(Uploaded-22-07-2019-15-51-08)-Study-related document.pdf



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.