Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001095550p
Ethics application status
Submitted, not yet approved
Date submitted
21/08/2024
Date registered
11/09/2024
Date last updated
11/09/2024
Date data sharing statement initially provided
11/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of the Stress Autism Mate application, a smartphone application designed to assist autistic adults in managing stress
Scientific title
Pilot study of the effect of Stress Autism Mate smartphone application on perceived stress and subjective wellbeing in autistic adults
Secondary ID [1] 312483 0
None
Universal Trial Number (UTN)
U1111-1310-7714
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 334431 0
Condition category
Condition code
Mental Health 331059 331059 0 0
Autistic spectrum disorders
Mental Health 331213 331213 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 331561 331561 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Stress Autism Mate smartphone app is a tool designed to support autistic adults to recognise and manage the stress of daily life. Users receive a prompt to complete a two-minute questionnaire twice a day, with a minimum interval of four hours between each questionnaire. Users will be guided through each engagement with the app via a pre-specified order of questions. The questionnaire asks what activities the user has done in the last four-hour interval, whether they felt energised or had positive thoughts during this interval and ends with ten multiple-choice questions about stress signals over the past four-hour interval. Items include ‘Did you feel irritable?’ and ‘Were you dreading activities on your schedule?’ Answers are scored and summed to identify the user’s stress level. Stress Autism Mate verifies the results by asking if they match the user’s perception; if there is a discrepancy, this is recorded on the overview page and can be used as a point of dialogue with a therapist or support person. After calculating the user’s stress level, Stress Autism Mate provides stress management tips which have been personally selected or created by the user. Examples include ‘Go for a walk’ or ‘Listen to some music’. At the end of each day and week, a feedback chart provides a visual overview of stress levels and summarises which activities contributed to feeling more stressed or less stressed. The feedback chart provides an accurate record which enables the user to identify activities which are contributing to stress.

Participants will download the Stress Autism Mate app onto their smartphone for use in their daily environment. They will use the app twice a day with a minimum of four-hour intervals between uses. Participants are requested to use the app only twice a day during the trial period, but are able to increase usage after the study period has concluded. The approximate duration of engagement with the app at each use is 2-4 minutes. They will continue to use the app twice daily for four weeks until the trial ends. Participants will have the option of contacting researchers during the four-week trial to receive assistance with downloading or using the app as needed, and researchers will also reach out via email to offer assistance. The study will collect usage data from the Stress Autism Mate app and self-report.
Intervention code [1] 329062 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338982 0
Perceived stress
Timepoint [1] 338982 0
Baseline, after 4 weeks of use (primary timepoint), and 4 weeks post-completion of intervention
Primary outcome [2] 338983 0
Perceived ability to cope with life challenges
Timepoint [2] 338983 0
Baseline, after 4 weeks of use (primary timepoint), and 4 weeks post-completion of intervention
Primary outcome [3] 338984 0
Subjective wellbeing
Timepoint [3] 338984 0
Baseline, after 4 weeks of use (primary timepoint), and 4 weeks post-completion of intervention
Secondary outcome [1] 438189 0
Researcher questions about stress recognition
Timepoint [1] 438189 0
Baseline, after 4 weeks of use, and 4 weeks post-completion of intervention
Secondary outcome [2] 439385 0
Researcher questions about app usage
Timepoint [2] 439385 0
After 4 weeks of use, and 4 weeks post-completion of intervention
Secondary outcome [3] 439386 0
Researcher questions about adverse effects
Timepoint [3] 439386 0
After 4 weeks of use
Secondary outcome [4] 439610 0
Researcher questions about changes in stress level
Timepoint [4] 439610 0
Baseline, after 4 weeks of use, and 4 weeks post-completion of intervention

Eligibility
Key inclusion criteria
Participants must be aged 18 and older, have either a formal diagnosis of autism or self-identify as autistic, and have experienced feelings of stress in the last month. The study will initially seek participants with a formal diagnosis of autism but will expand to include those who self-identify if additional participants are needed. All participants must have the ability to read and type English (participants will self-select), have a smartphone, and be residents of Australia or New Zealand.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are currently undergoing another intervention for stress.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26486 0
New Zealand
State/province [1] 26486 0

Funding & Sponsors
Funding source category [1] 316902 0
University
Name [1] 316902 0
Deakin University School of Psychology as part of the Doctor of Psychology (clinical) post-graduate program
Country [1] 316902 0
Australia
Primary sponsor type
University
Name
Deakin University School of Psychology
Address
Country
Australia
Secondary sponsor category [1] 319151 0
None
Name [1] 319151 0
Address [1] 319151 0
Country [1] 319151 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315661 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315661 0
Ethics committee country [1] 315661 0
Australia
Date submitted for ethics approval [1] 315661 0
06/05/2024
Approval date [1] 315661 0
Ethics approval number [1] 315661 0

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

Contacts
Principal investigator
Name 135414 0
A/Prof Mark A. Stokes
Address 135414 0
Deakin University, School of Psychology, Faculty of Health, 221 Burwood Highway, Burwood, Vic, 3125, Australia
Country 135414 0
Australia
Phone 135414 0
+61 3 92446865
Fax 135414 0
Email 135414 0
[email protected]
Contact person for public queries
Name 135415 0
Mark A. Stokes
Address 135415 0
Deakin University, School of Psychology, Faculty of Health, 221 Burwood Highway, Burwood, Vic, 3125, Australia
Country 135415 0
Australia
Phone 135415 0
+61 3 92446865
Fax 135415 0
Email 135415 0
[email protected]
Contact person for scientific queries
Name 135416 0
Mark A. Stokes
Address 135416 0
Deakin University, School of Psychology, Faculty of Health, 221 Burwood Highway, Burwood, Vic, 3125, Australia
Country 135416 0
Australia
Phone 135416 0
+61 3 92446865
Fax 135416 0
Email 135416 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?
De-identified individual line-by-line data.
When will data be available (start and end dates)?
Immediately following publication for seven years.
Available to whom?
Other researchers may request access to the data to verify results or perform additional analysis in the future.
Available for what types of analyses?
All analyses
How or where can data be obtained?
Contact principal investigator via email [email protected]


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.