Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001436167
Ethics application status
Approved
Date submitted
8/10/2019
Date registered
16/10/2019
Date last updated
16/10/2019
Date data sharing statement initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Headstrong: a ChatBot to support the emotional wellbeing in older adolescents
Scientific title
Open trial to evaluate engagement and acceptability of
Headstrong: a ChatBot to support the emotional wellbeing in older adolescents
Secondary ID [1] 299492 0
None
Universal Trial Number (UTN)
U1111-1238-3866
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional wellbeing 314727 0
Condition category
Condition code
Mental Health 313061 313061 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Headstrong is a digital intervention that sits on the HABITs (Health Advances through Behaviour Intervention Technologies) platform - a digital ecosystem developed by the University of Auckland to manage a body of research around the use of digital technologies for mental health support.
Participants are directed to this platform, where they first register, then consent electronically to the study and proceed to complete baseline measures. Participants are then instructed (via a link) on how to activate the chatbot using their Facebook Messenger.
The Chatbot is designed for daily use and is hosted via the Facebook Messenger Platform. Users are able to choose their own “Chatbot Persona” (Aroha, Olivia, Manaia, or Ravi) to make the Chatbot more engaging.
The content of the intervention is steeped in cognitive behavioural (CBT) framework that includes relaxation, problem solving, identifying and challenging negative thoughts. Interpersonal skills (communication, negotiation, assertiveness) are also part of the program. Principles of positive psychology (e.g. gratitude journal), goal setting are also included. Other elements such as jokes, distraction games and motivational quotes are used to enhance appeal and engagement.
The focus of the intervention is to teach positive coping skills, increase resilience and emotional wellbeing. A typical daily interaction with the Headstrong chatbot takes about 5 minutes. It consists of:
1) a message/notification from the chatbot at an agreed time
2) brief mood check in (on a 5 point Likert scale using emojis)
3) a choice of an activity (e.g. STEPS aka problem solving or another skill)
4) an option to enter something into the gratitude journal
5) a joke, motivational quote or another 'random' activity' (e.g. a brief relaxation exercise).
Gamification elements (e.g. badges as rewards for completion of activities) are designed to enhance continuous engagement.
Content is delivered in short, easy to digest segments of psycho-education followed by examples and activities for participants to practice.
For this evaluation, the intervention period will be four weeks. Participants are free to use the chatbot as much or as little as they choose during the 4-week period, usage data will be accessed via the HABITs platform to analyse adherence.
The Chatbot has been designed in conjunction with the University of Auckland HABITs research team and Rush Digital (a creative design and technology studio).
Intervention code [1] 315752 0
Prevention
Intervention code [2] 315823 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321612 0
The primary aim of this study is to determine whether a Chatbot (conversational agent) for emotional wellbeing is engaging for older adolescents.
Engagement will be measured via usage data, which is collected for the duration of the 4-week intervention period. When a participant is interacting with the chatbot, the HABITs IT platform uses the HABITs API to send usage information to researchers - date when the chatbot was initiated, frequency of use, when the tool is used (time and date stamp), which activities/days are completed.
Timepoint [1] 321612 0
This outcome is collected for the duration of the intervention period and will be analysed for the period up to completion of post-intervention outcome measures (between 4-6 weeks)
Secondary outcome [1] 375574 0
Participant perception of the Chatbot: chatbot ratings. A scale developed for this study will be used as a satisfaction rating: 7 questions on a 5 point Likert scale, followed by an overall rating on a scale of 0 - 10 (designed for this trial). Participants will be asked to complete it at at post-intervention (between 4-6 weeks) and provide a brief feedback review.
Timepoint [1] 375574 0
4 -6 weeks (post-intervention)
Secondary outcome [2] 375575 0
Self-reported mood ratings ('emojis' on a 5 point scale) momentary assessments within the chatbot conversation. This was designed for this trial.
Timepoint [2] 375575 0
Daily (during the intervention period)
Secondary outcome [3] 375576 0
Personal Wellbeing Measure (ONS4) asked weekly to collect information on life satisfaction; perception of worth of activities in their life; happiness; and anxiety. This is presented within the Chatbot using a simple visual scale assessment with a Likert Scale and emojis.
Timepoint [3] 375576 0
Baseline (0 weeks) and then weekly (e.g. 1,2,3...) and post-intervention (4-6 weeks)
Secondary outcome [4] 375577 0
Changes in self-reported wellbeing after completion of treatment compared with baseline using the WHO (Five) Wellbeing Index (WHO-5)
Timepoint [4] 375577 0
Baseline (0 weeks) & 4-6 weeks
Secondary outcome [5] 375598 0
Sustained use of the chatbot - measured via usage data i.e. frequency of use, when the tool is used (time and date stamp), which activities/days are completed.
Timepoint [5] 375598 0
Up to 8 weeks

Eligibility
Key inclusion criteria
1) Aged 16 years of age or older (on the day of consent);
2) Enrolled or attending a participating New Zealand secondary school, alternative education provide or a partner organisation;
3) They have access to a device that is able to run and support the use of Facebook Messenger.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
This is an open trial and no exclusion criteria exist

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is not required. All participants are given access to the Chatbot
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is an open access trial so all participants are given access to the Chatbot and no blind occurs.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline data will be summarised using standard descriptive statistics including means, medians, ranges and standard deviations and frequencies and percentages, as appropriate.
Descriptive summaries including means, medians, ranges and standard deviations and frequencies and percentages will be used to describe Chatbot usage behaviour and responses provided in the Chatbot rating scale. These descriptive summaries will be estimated for the number of times the Chatbot is accessed, the average time spent on the daily interaction with the Chatbot, adherence over the 4 weeks and the stability of the platform and the Chatbot.
Descriptive data, include means and standard deviations, will be used to describe responses to the within-Chatbot Likert scales and the wellbeing measures. Changes over time will be estimated by calculating effect sizes for the Likert scales and wellbeing measures.
The Chatbot rating and usage data will be summarised for the all those completing these scales and additionally will be summarised for Maori/Pacific and non-Maori, non-Pacific participants and compared between these two groups if sufficiently large. 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
21/10/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
25/02/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 21912 0
New Zealand
State/province [1] 21912 0
Auckland

Funding & Sponsors
Funding source category [1] 303988 0
Government body
Name [1] 303988 0
The Ministry for Business, Innovation and Employment
Country [1] 303988 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The Research Office
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 304161 0
None
Name [1] 304161 0
Address [1] 304161 0
Country [1] 304161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304485 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 304485 0
Ethics committee country [1] 304485 0
New Zealand
Date submitted for ethics approval [1] 304485 0
Approval date [1] 304485 0
07/10/2019
Ethics approval number [1] 304485 0
19/NTA/123

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

Contacts
Principal investigator
Name 97110 0
Dr Karolina Stasiak
Address 97110 0
The Department of Psychological Medicine
The Faculty of Medical and Health Sciences
The University of Auckland
85 Park Road
Grafton 1023
Auckland

Postal Address
Private Bag 92019
Auckland 1142
Country 97110 0
New Zealand
Phone 97110 0
+64 99233890
Fax 97110 0
Email 97110 0
[email protected]
Contact person for public queries
Name 97111 0
Karolina Stasiak
Address 97111 0
The Department of Psychological Medicine
The Faculty of Medical and Health Sciences
The University of Auckland
85 Park Road
Grafton 1023
Auckland

Postal Address
Private Bag 92019
Auckland 1142
Country 97111 0
New Zealand
Phone 97111 0
+64 99233890
Fax 97111 0
Email 97111 0
[email protected]
Contact person for scientific queries
Name 97112 0
Karolina Stasiak
Address 97112 0
The Department of Psychological Medicine
The Faculty of Medical and Health Sciences
The University of Auckland
85 Park Road
Grafton 1023
Auckland

Postal Address
Private Bag 92019
Auckland 1142
Country 97112 0
New Zealand
Phone 97112 0
+64 99233890
Fax 97112 0
Email 97112 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?
The research team may be happy to share de-identified patient data and usage data but will need to be contacted to be discussed
When will data be available (start and end dates)?
To be confirmed
Available to whom?
Please contact the research team to discuss as will be evaluated on a case by case basis
Available for what types of analyses?
To be discussed with the research team.
How or where can data be obtained?
Likely to be provided in a passworded database (eg. excel or spss) file. To be discussed and arranged with the research team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5348Ethical approval  [email protected]
5349Study protocol  [email protected]
5352Informed consent form  [email protected]
5354Statistical analysis plan  [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.