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Trial registered on ANZCTR


Registration number
ACTRN12618000273280
Ethics application status
Approved
Date submitted
15/02/2018
Date registered
22/02/2018
Date last updated
22/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open pilot trial of a prototype emotional wellbeing app for adolescents
Scientific title
A proof of concept study to evaluate the first prototype HABITs app to support emotional wellbeing of adolescents
Secondary ID [1] 294056 0
None
Universal Trial Number (UTN)
U1111-1202-5836
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 306614 0
Depression 306615 0
Condition category
Condition code
Mental Health 305712 305712 0 0
Depression
Mental Health 305713 305713 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention ("the HABITs app") is an app available to study participants for download on their personal Android smart phone for self-directed use for the duration of the trial. For this pilot trial, the treatment period will be approximately three weeks.

The HABITs app is the first prototype of an interactive, gamified app designed to support emotional wellbeing of young people. In its present format (designed as a proof of concept prototype), it consists of three modules providing relaxation training, a gratitude journal and an exercise to identify strategies to deal with unhelpful feelings.
Intervention code [1] 300334 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304791 0
Acceptability of the app - evaluated using Satisfaction ratings (Satisfaction questionnaire developed for purpose) and qualitative feedback (semi-structured interviews) from participants
Timepoint [1] 304791 0
Post-intervention - 3-4 weeks after intervention commencement
Primary outcome [2] 304792 0
Ease of use - evaluated via usage data collected via linkages to secure individual user accounts to the HABITS platform. Specific outcomes include: total time spent using app (seconds), frequency of app usage and module completion.
Timepoint [2] 304792 0
Collected passively for duration of the intervention period.
Secondary outcome [1] 343213 0
Estimated efficacy using changes in self-reported symptoms of depression using Patient Health Questionnaire 9-item depression scale - Adolescent (PHQ-A)
Timepoint [1] 343213 0
Baseline, Post-intervention - 3-4 weeks after intervention commencement.
Secondary outcome [2] 343214 0
Estimated efficacy evaluated using changes in self-reported symptoms of anxiety using the Generalized Anxiety Disorder Screener (GAD-7)
Timepoint [2] 343214 0
Baseline and post-intervention - 3-4 weeks after intervention commencement
Secondary outcome [3] 343215 0
Estimate of efficacy using changes in self-reported symptoms using within-app momentary assessments. Momentary assessents are simple visual sliding scale assessments scheduled immediately before and after completion of each of the three module activities. These within app likert scales (quantified on a scale from 0-1) collect information on perceived stress for the relaxation module, perceived happiness for the gratitude journal and perceived control over unhelpful feelings for the Think-Feel-Do module. 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 [3] 343215 0
Evaluated every time they use the app.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if:
•They are aged 13-16 years of age (on the day of consent);
•They have sufficient English language ability to understand the app;
•They have an Android smart phone;
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be ineligible for this study if:
•They have an intellectual disability or physical limitation that would result in them not being able to use the app/ smart phone;
•They are unable to sufficiently understand the nature of study involvement or to provide written informed consent;

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive data will be used to describe app usage behaviour, including 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 3 weeks and the stability of the platform and the app. Descriptive data, include means and standard deviations, will be used to describe responses to the within-app Likert scales and the PHQ-A and GAD-7. Changes over time will be estimated for this pilot study by calculating effect sizes for the Likert scales, PHQ-A and GAD-7.

Qualitative data will be analysed using a general inductive approach [Thomas, DR. 2016]. In this approach, a detailed review of focus group and interview data is guided by the research questions and emerging themes are identified until all the data are categorised.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/02/2018
Date of last participant enrolment
Anticipated
30/03/2018
Actual
Date of last data collection
Anticipated
30/04/2018
Actual
Sample size
Target
40
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 9589 0
New Zealand
State/province [1] 9589 0
Auckland

Funding & Sponsors
Funding source category [1] 298682 0
Government body
Name [1] 298682 0
Ministry of Business, Innovation and Employment
Country [1] 298682 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] 297853 0
None
Name [1] 297853 0
Address [1] 297853 0
Country [1] 297853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299636 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 299636 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 299636 0
New Zealand
Date submitted for ethics approval [1] 299636 0
02/10/2017
Approval date [1] 299636 0
30/11/2017
Ethics approval number [1] 299636 0
17/NTA/205

Summary
Brief summary
This is a proof of concept pilot study to evaluate the a prototype emotional wellbeing app with a view to refining content and design elements in order to create a 2nd generation emotional wellbeing app in 2018. The main objective of the study is to evaluate acceptability, ease of use and estimate efficacy of the first generation HABITs app for emotional wellbeing. Participants are consented volunteers, aged 13-16 years from participating New Zealand secondary schools. This will be an open pilot trial with 20-40 participants. Students will be recruited via participating schools through pastoral care staff or in response to a presentation to students by the study team. To be eligible they must have sufficient English language ability to understand the app and have access to an Android smart phone. Outcome data will be collected pre- and post-intervention and passive data collection will be used in the three-week intervention period to report on app use on their own Android smartphone. Primary outcomes for acceptability and usability are 1) Usage data, and 2) Satisfaction ratings and qualitative feedback. We will estimate efficacy using changes in self-reported symptoms using PHQ-A and GAD7 and within-app likert scales.
Trial website
Trial related presentations / publications
Public notes
Participant safety considerations
•Any individual who scores >14 on the PHQ-A or reports 2-3 on question 9 will be referred to the guidance counsellor or school pastoral carer for additional support.
•These individuals, and any individual who reports receiving, or having recently received (past 3 months), counselling or a prescription for antidepressant medication, will still be provided access to the intervention and their usage data and feedback on the app will be included in the analyses, but pre-post PHQ-A and GAD-7 data will not be included in any estimated effect sizes.

Contacts
Principal investigator
Name 81118 0
Dr Karolina Stasiak
Address 81118 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 81118 0
New Zealand
Phone 81118 0
+64 9 923 3890
Fax 81118 0
Email 81118 0
[email protected]
Contact person for public queries
Name 81119 0
Sarah Hopkins
Address 81119 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 81119 0
New Zealand
Phone 81119 0
+64 9 923 2015
Fax 81119 0
Email 81119 0
[email protected]
Contact person for scientific queries
Name 81120 0
Karolina Stasiak
Address 81120 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 81120 0
New Zealand
Phone 81120 0
+64 9 923 3890
Fax 81120 0
Email 81120 0
[email protected]

No information has been provided regarding IPD availability


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
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