Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001282875
Ethics application status
Approved
Date submitted
4/08/2021
Date registered
23/09/2021
Date last updated
23/09/2021
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Augmented reality technology to deliver cognitive and behavioural therapies for the treatment of symptoms of anxiety among teenagers with asthma
Scientific title
Feasibility of augmented reality technology to deliver cognitive and behavioural therapies for the treatment of symptoms of anxiety among teenagers with asthma
Secondary ID [1] 304959 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 323106 0
Condition category
Condition code
Respiratory 320682 320682 0 0
Asthma
Mental Health 320866 320866 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of Augmented Reality (AR) resources designed to deliver a component of a psychological intervention. Access to these resources will be facilitated via a smartphone app, and a workbook containing information about asthma and mental health (this workbook was developed by research staff and refined by experts in Psychology and Respiratory Health). The intervention will predominantly be delivered via videos and voice-overs presented by the research team's Clinical Psychologist or Paediatric Respiratory Specialist. Participants will be asked to use the app as much as they wish over a 1-month period, and will receive push notifications weekly reminding them to use the app. Useage data will be collected throughout the intervention period.
Intervention code [1] 321349 0
Treatment: Devices
Comparator / control treatment
Control participants will have access to the smartphone app (which will include links to credible online self-help websites and self-monitoring questionnaires), but will not be able to access the AR resources.
Control group
Active

Outcomes
Primary outcome [1] 328503 0
Change in use of smartphone resource, measured through smartphone access logs.
Timepoint [1] 328503 0
Baseline, 1 month post-commencement of intervention
Secondary outcome [1] 399214 0
Change in symptoms of anxiety as measured by the Youth Asthma-related Anxiety Scale
Timepoint [1] 399214 0
Baseline, 1 month post-commencement of intervention
Secondary outcome [2] 399215 0
Change in quality of life as measured by the Paediatric Asthma Quality of Life Questionnaire
Timepoint [2] 399215 0
Baseline, 1 month post-commencement of intervention

Eligibility
Key inclusion criteria
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; have experienced or are currently experiencing heightened symptoms of anxiety determined by self-report; have access to a smartphone with the owner’s permission to use it; are English speaking/able to understand written English.
Minimum age
13 Years
Maximum age
17 Years
Sex
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to intervention or control via computer-generated, centralised randomisation sequence. Consecutively numbered opaque, sealed envelopes will be used to enclose the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to intervention or control via computer-generated randomisation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant flow through the trial will be displayed using a CONSORT diagram. Analysis of the questionnaire data will be descriptive, with counts and percentages for categorical data, and means and standard deviations for continuous data compared between baseline and follow-up. Missing information from quantitative scales and surveys will be accounted for through random imputation. Drop-outs or loss to follow-up will be compared between study arms, and against those remaining in the trial. For continuous outcome variables mixed effects linear models will be used. For other outcome measures mixed effects generalized linear models will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
Date of last participant enrolment
Anticipated
29/10/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20134 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 34855 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 309344 0
Charities/Societies/Foundations
Name [1] 309344 0
Channel 7 Children's Research Foundation
Country [1] 309344 0
Australia
Funding source category [2] 309345 0
University
Name [2] 309345 0
University of South Australia
Country [2] 309345 0
Australia
Funding source category [3] 309347 0
Government body
Name [3] 309347 0
National Health and Medical Research Council (NHMRC)
Country [3] 309347 0
Australia
Funding source category [4] 309348 0
Charities/Societies/Foundations
Name [4] 309348 0
Hospital Research Foundation
Country [4] 309348 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 310312 0
None
Name [1] 310312 0
Address [1] 310312 0
Country [1] 310312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309163 0
Women’s and Children’s Health Network (WCHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 309163 0
72 King William Road, North Adelaide SA 5006
Ethics committee country [1] 309163 0
Australia
Date submitted for ethics approval [1] 309163 0
Approval date [1] 309163 0
19/07/2021
Ethics approval number [1] 309163 0
Ethics committee name [2] 309164 0
UniSA Human Research Ethics Committee
Ethics committee address [2] 309164 0
GPO Box 2471, Adelaide SA, 5001
Ethics committee country [2] 309164 0
Australia
Date submitted for ethics approval [2] 309164 0
02/08/2021
Approval date [2] 309164 0
04/08/2021
Ethics approval number [2] 309164 0
204144

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 augmented reality technology (AR) as a delivery mechanism for a component of CBT. Development of AR tools have been guided by a comprehensive protocol for health program development, with direction from experts in Design, Information Technology, Respiratory Medicine, and Psychology. The practicality and feasibility of these tools for use by youth, their parents/guardians, and health professionals will be explored through this feasibility pilot study with 1-month follow-up. 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 113202 0
A/Prof Kristin Carson-Chahhoud
Address 113202 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 113202 0
Australia
Phone 113202 0
+61 08 8302 0453
Fax 113202 0
Email 113202 0
[email protected]
Contact person for public queries
Name 113203 0
Kelsey Sharrad
Address 113203 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 113203 0
Australia
Phone 113203 0
+61 08 8302 2734
Fax 113203 0
Email 113203 0
[email protected]
Contact person for scientific queries
Name 113204 0
Kristin Carson-Chahhoud
Address 113204 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 113204 0
Australia
Phone 113204 0
+61 08 8302 0453
Fax 113204 0
Email 113204 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePsychological interventions for asthma in children and adolescents.2024https://dx.doi.org/10.1002/14651858.CD013420.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.