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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
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Scientific title
A proof of concept study to evaluate the first prototype HABITs app to support emotional wellbeing of adolescents
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Secondary ID [1]
294056
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None
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Universal Trial Number (UTN)
U1111-1202-5836
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
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Depression
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Condition category
Condition code
Mental Health
305712
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0
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Depression
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Mental Health
305713
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
300334
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Acceptability of the app - evaluated using Satisfaction ratings (Satisfaction questionnaire developed for purpose) and qualitative feedback (semi-structured interviews) from participants
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Assessment method [1]
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Timepoint [1]
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Post-intervention - 3-4 weeks after intervention commencement
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Collected passively for duration of the intervention period.
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Secondary outcome [1]
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Estimated efficacy using changes in self-reported symptoms of depression using Patient Health Questionnaire 9-item depression scale - Adolescent (PHQ-A)
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Assessment method [1]
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Timepoint [1]
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Baseline, Post-intervention - 3-4 weeks after intervention commencement.
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Secondary outcome [2]
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Estimated efficacy evaluated using changes in self-reported symptoms of anxiety using the Generalized Anxiety Disorder Screener (GAD-7)
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Assessment method [2]
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Timepoint [2]
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Baseline and post-intervention - 3-4 weeks after intervention commencement
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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Evaluated every time they use the app.
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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;
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Minimum age
13
Years
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
16/02/2018
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Date of last participant enrolment
Anticipated
30/03/2018
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Actual
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Date of last data collection
Anticipated
30/04/2018
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Actual
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Sample size
Target
40
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Accrual to date
5
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Ministry of Business, Innovation and Employment
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Address [1]
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PO Box 1473,
Wellington 6140
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Research Office
University of Auckland
Private Bag 92019
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
297853
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
299636
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
299636
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02/10/2017
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Approval date [1]
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30/11/2017
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Ethics approval number [1]
299636
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17/NTA/205
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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.
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Trial website
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Trial related presentations / publications
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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.
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Contacts
Principal investigator
Name
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Dr Karolina Stasiak
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Address
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Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 3890
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Sarah Hopkins
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Address
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Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 2015
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Karolina Stasiak
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Address
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Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
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Country
81120
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New Zealand
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Phone
81120
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+64 9 923 3890
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Fax
81120
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Email
81120
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[email protected]
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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
No additional documents have been identified.
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