COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. 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
ACTRN12620001109998
Ethics application status
Approved
Date submitted
31/08/2020
Date registered
27/10/2020
Date last updated
27/10/2020
Date data sharing statement initially provided
27/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mixed reality and holographic technologies to deliver cognitive and behavioural therapies for the treatment of symptoms of anxiety among teenagers with asthma
Scientific title
Mixed reality technology as a delivery mechanism for psychological intervention in adolescents with asthma
Secondary ID [1] 302092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 318855 0
Psychological distress 318856 0
Condition category
Condition code
Respiratory 316858 316858 0 0
Asthma
Mental Health 316859 316859 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a qualitative study, seeking to explore the use of mixed reality technologies (augmented reality (AR), virtual reality (VR), holographics) as a delivery mechanism for cognitive and behavioural therapies (CBT) in the treatment of elevated psychological distress among young people with asthma.

The mixed reality resources are yet to be developed. They will be based on a component of CBT, and will be developed by the investigator team's Clinical Psychologist. A needs review for this study is currently underway, which will be used to inform the development of these resources.

To determine facilitators and barriers for use of each mixed reality tool as well as evaluating perceptions of usability and appropriateness to reach target audience, qualitative research will be carried out through focus groups and one-on-one interviews. During the sessions, mixed reality tools will be demonstrated and participants allocated time to interact with the resources themselves. Semi-structured moderator guides based on rigorous, systematic frameworks will be used to direct n=4 focus groups with n=6 young people in each group, conducted separately for age ranges 13-15 and 16-17 years. Two focus groups will also be conducted with n=6 parents in each, as well as one-on-one interviews with n=10 health professionals. Each participant will be involved in only one focus group/interview. Qualitative interviews will be supplemented with a questionnaire including Likert scales to facilitate triangulation of data, and the System Useability Scale to identify useability data. Each participant group will utilise the tools under the same protocol.

One-on-one interviews will run for approximately one hour, while focus groups will run for 2.5 to 3 hours. Interviews and focus groups will take place in meeting spaces in the respiratory department at Women’s Women's and Children’s Children's Hospital (WCH), and paediatric department at Flinders Medical Centre (FMC), and will be staggered to allow for an iterative co-design process of study tools.
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324967 0
Understanding of the feasibility of mixed reality resources for use by youth (13-17 years) through focus groups with young people with asthma.
Timepoint [1] 324967 0
At once-off focus group
Primary outcome [2] 325271 0
Understanding of the feasibility of mixed reality tools for use by youth (13-17 years) through focus groups with parents/caregivers of young people with asthma.
Timepoint [2] 325271 0
At once-off focus group
Primary outcome [3] 325272 0
Understanding of the feasibility of mixed reality tools for use by youth (13-17 years) through interviews with healthcare professionals.
Timepoint [3] 325272 0
At once-off focus group
Secondary outcome [1] 386376 0
Usability of the mixed reality tools will be assessed using the System Usability Scale
Timepoint [1] 386376 0
At once-off focus group

Eligibility
Key inclusion criteria
Inclusion criteria for young people: Young people will be eligible for inclusion in this study if they: are aged between 13 and 17 years; have been formally diagnosed with asthma by a health professional (inpatients or outpatients); have experienced or are currently experiencing heightened symptoms of psychological distress determined by the K10+ scale; have access to a smartphone with the owner’s permission to use it; are English speaking/able to understand written English.

Inclusion criteria for caregivers/parents: Participants will be eligible for inclusion in this study if they: are the caregiver/parent of a child with asthma (aged 13 to 17 years) who currently has/or has reported in the past heightened symptoms of psychological distress (does not need to be the parent/caregiver of a child actively participating in this study); have access to a smartphone and able to use smartphone technology (basic level); are English speaking/able to understand written English.

Inclusion criteria for health professionals: Health professionals will be eligible for inclusion in this study if they: have been practicing in their respective fields for at least 12-months; have access to a smartphone and are able to use smartphone technology (basic level); are English speaking/able to understand written English.
Minimum age
13 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with an intellectual disability or cognitive impairment that would inhibit their ability to provide informed consent and participate in the project will be ineligible to participate. Young people with a history of epilepsy or other contraindication for the use of VR will also be ineligible to participate.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Qualitative data will be coded using three pre-specified lenses to enable insight into different aspects of the mixed reality interventions. This includes: the Theroetical Domains Framework to aid knowledge translation potential, the Theoretical Framework of Acceptability to evaluate acceptability of the mixed reality intervention as a method to deliver CBT to young people with asthma, and the Enlight protocol (an evaluation tool for mobile eHealth interventions) to evaluate quality and therapeutic potential for the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17374 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 17375 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 31103 0
5006 - North Adelaide
Recruitment postcode(s) [2] 31104 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 306511 0
Charities/Societies/Foundations
Name [1] 306511 0
Channel 7 Children's Research Foundation
Address [1] 306511 0
Novita Children's Services, Located at, 341 Port Rd, Hindmarsh SA 5007
Country [1] 306511 0
Australia
Funding source category [2] 306608 0
University
Name [2] 306608 0
University of South Australia
Address [2] 306608 0
GPO Box 2471, Adelaide SA 5001
Country [2] 306608 0
Australia
Funding source category [3] 306609 0
Government body
Name [3] 306609 0
National Health and Medical Research Council (NHMRC)
Address [3] 306609 0
GPO Box 1421
Canberra ACT 2601
Country [3] 306609 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 307039 0
None
Name [1] 307039 0
Address [1] 307039 0
Country [1] 307039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306715 0
Women’s and Children’s Health Network (WCHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 306715 0
72 King William Rd, North Adelaide SA 5006
Ethics committee country [1] 306715 0
Australia
Date submitted for ethics approval [1] 306715 0
Approval date [1] 306715 0
03/06/2019
Ethics approval number [1] 306715 0
Ethics committee name [2] 306793 0
UniSA Human Research Ethics Committee
Ethics committee address [2] 306793 0
GPO Box 2471, Adelaide SA 5001
Ethics committee country [2] 306793 0
Australia
Date submitted for ethics approval [2] 306793 0
28/06/2019
Approval date [2] 306793 0
Ethics approval number [2] 306793 0

Summary
Brief summary
A range of challenges faced by children and adolescents with asthma contribute to their increased experience of psychological distress and lower quality of life than peers without asthma. Psychological interventions such as cognitive and behavioural therapies (CBT) may provide young people with techniques and strategies to manage symptoms of psychological distress and therefore symptoms of asthma, to avoid exacerbations. However, reports indicate low uptake of psychological intervention in this age group, with youth preferring to seek help themselves via internet sources. To improve access to and uptake of evidence-based treatments for elevated psychological distress in adolescents (aged 13-17 years) with asthma, this project will evaluate mixed reality technology (augmented reality, virtual reality, holographic technology) as a delivery mechanism for a component of CBT. Development of mixed reality tools will be guided by a comprehensive protocol for health program development, with direction from experts in Design, Information Technology, Respiratory Medicine, and Psychology. The acceptability of these technologies for use by youth, their parents/guardians, and health professionals will be explored through qualitative research: focus groups and one-on-one interviews. This study will provide essential pilot data to guide development of a fully powered randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104766 0
A/Prof Kristin Carson-Chahhoud
Address 104766 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 104766 0
Australia
Phone 104766 0
+61 08 8302 0453
Fax 104766 0
Email 104766 0
kristin.carson-chahhoud@unisa.edu.au
Contact person for public queries
Name 104767 0
Mrs Kelsey Sharrad
Address 104767 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 104767 0
Australia
Phone 104767 0
+61 08 8302 2734
Fax 104767 0
Email 104767 0
kelsey.sharrad@unisa.edu.au
Contact person for scientific queries
Name 104768 0
Mrs Kelsey Sharrad
Address 104768 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 104768 0
Australia
Phone 104768 0
+61 08 8302 2734
Fax 104768 0
Email 104768 0
kelsey.sharrad@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results