Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000978460
Ethics application status
Approved
Date submitted
22/04/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The SenseVest Trial: Investigating the effect of sensory vests on autistic children's mental health.
Scientific title
Effect, cost-effectiveness and acceptability of a sensory vest on autistic children's anxiety, sensory regulation, self-regulation, sleep and physical activity: a Phase 2 randomised placebo-controlled trial.
Secondary ID [1] 314257 0
MRF2035705
Universal Trial Number (UTN)
Trial acronym
SenseVest
Linked study record
ACTRN12622001244796 is the pilot study that preceded and informed the current trial.

Health condition
Health condition(s) or problem(s) studied:
anxiety 337179 0
autism 337180 0
Condition category
Condition code
Mental Health 333595 333595 0 0
Autistic spectrum disorders
Mental Health 333596 333596 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sensory vest is clothing worn close to the body, generally as an undergarment. The best is made from stretchy, wicking fabric. The vest is sleeveless and covers the torso finishing at the upper hips. Participants will be asked to wear the vest daily for a minimum of 6 continuous hours. Participants will wear the vest for 3 months. Full adherence to this schedule will be defined as meeting 80% of this dosage regime. Participants can wear the vest for longer than 6 hours per day if desired. Participants are to carry out their daily activities as per usual while wearing the vest. No additional tasks or activities above and beyond the study visits and completion of surveys are required. Caregivers of participants are asked to report on hours that the vest was worn for the previous two days, every second day via a prompt notification to their smartphone.
Intervention code [1] 330869 0
Treatment: Devices
Comparator / control treatment
The placebo sensory vest is manufactured from the same fabric and design template as the active sensory vest but is two sizes larger so does not offer any compressive effect.
Control group
Placebo

Outcomes
Primary outcome [1] 341174 0
Child anxiety
Timepoint [1] 341174 0
T0 (study entry) and T4 (study exit-end of 12 weeks of intervention) . T4 is considered the primary endpoint for the primary outcomes.
Primary outcome [2] 342641 0
Child anxiety
Timepoint [2] 342641 0
T1 (baseline, pre-intervention) T2 (1 month following intervention commencement) T3 (2 months following intervention commencement) T4 (study exit-end of 12 weeks of intervention)
Secondary outcome [1] 446651 0
Sensory regulation
Timepoint [1] 446651 0
Study baseline (T1 pre-intervention) Study exit (T4 - end of 12 weeks intervention).
Secondary outcome [2] 446653 0
Sensory regulation - sensory tactile discomfort
Timepoint [2] 446653 0
Every second day via child/parent report on MyCap from intervention commencement until T4, end of 12 weeks intervention
Secondary outcome [3] 446656 0
Goal Attainment Scaling of self-regulation goals
Timepoint [3] 446656 0
T1 (baseline, pre-intervention) T2 (1 month following intervention commencement) T3 (2 months following intervention commencement) T4 (study exit-end of 12 week)
Secondary outcome [4] 446657 0
Sleep quality
Timepoint [4] 446657 0
Study baseline (T1 -one month following intervention commencement ), study exit (T4 - end of 12 weeks intervention).
Secondary outcome [5] 446658 0
Cost-effectiveness
Timepoint [5] 446658 0
Study baseline (T1 - pre-intervention) Study exit (T4 - end of 12 week intervention)
Secondary outcome [6] 446659 0
Acceptability- this will be assessed as a composite outcome.
Timepoint [6] 446659 0
1. Every other day by parent report via MyCap across study baseline (T1 - pre-intervention) until study exit (T4 - end of 12 week intervention), 2. Study exit (T4 - end of 12 week intervention) 3. Study baseline (T1 - pre-intervention) and study exit (T4 - end of 12 week intervention)
Secondary outcome [7] 451343 0
Observed behavioural self-regulation
Timepoint [7] 451343 0
T1 (baseline, pre-intervention) T2 (1 month following intervention commencement) T3 (2 months following intervention commencement) T4 (study exit- end of 12 week intervention)
Secondary outcome [8] 451344 0
Child mood
Timepoint [8] 451344 0
Every other day via MyCap app from intervention commencement to T4 (study exit- end of 12 week intervention).
Secondary outcome [9] 451371 0
Physical activity
Timepoint [9] 451371 0
Completed weekly during intervention until T4 (study exit-end of 12 weeks intervention).
Secondary outcome [10] 451648 0
Sensory regulation
Timepoint [10] 451648 0
Study baseline (T1 - pre-intervention) Study exit (T4 - end of 12 week intervention).
Secondary outcome [11] 451649 0
Sensory regulation
Timepoint [11] 451649 0
Study baseline (T1 - pre-intervention) Study exit (T4 - end of 12 weeks intervention)
Secondary outcome [12] 451650 0
Sleep quality
Timepoint [12] 451650 0
Weekly from intervention commencement to T4 (end of 12 weeks intervention).
Secondary outcome [13] 451651 0
Sleep quality
Timepoint [13] 451651 0
Every other day by parent report via MyCap from intervention commencement to T4 (study exit-end of 12 weeks intervention).
Secondary outcome [14] 451652 0
Cost-effectiveness
Timepoint [14] 451652 0
Study baseline (T1 - pre-intervention) study exit (T4 - end of 12 week intervention)

Eligibility
Key inclusion criteria
1. Child age between 8-12 years
2. Formal diagnosis by qualified practitioner (clinical psychologist, paediatrician or psychiatrist)
3. Can reliably indicate discomfort or pain to a familiar adult using verbal or non-verbal means as assessed by the Pragmatics Profile of Everyday Communication Skills.
4. Experience clinically significant sensory dysregulation (assessed via the Short Sensory Profile)
5. Experience clinically significant anxiety (assessed via Anxiety Scale for Children-Autism Spectrum Disorder
6. Able to attend study visits in either Melbourne or Perth
7. No prior use of sensory clothing
8. Have a legal guardian who can provide informed consent
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not autistic
2. Unable to provide informed consent (parent/guardian)
3. Unable to reliably indicate discomfort
4. No experience of clinically significant sensory dysregulation or anxiety
5. Unable to tolerate sensory or placebo vest
6. Unable to attend study visits in either Melbourne or Perth
7. Has previously used or currently using JettProof sensory clothing (or equivalent)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. The La Trobe University Clinical Trials Platform will independently conduct randomisation using an online randomisation sequence generator (Sealed Envelope) to generate the sequence. The sequence will then be securely uploaded to the project’s REDCap database. Only the trial coordinators at each site will have access to the randomisation page in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks with 1:1 allocation, stratified for site (Vic, WA).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Target sample size: n=140
Sample size calculation - Our pilot data indicated a moderate to high effect for decrease in electrodermal activity during the intervention phase (Cohen’s d range: mean -0.55 to -0.64; median –0.62 to -0.65; p=0.03 for both). Our sample size of 70 per group, provides 80% power to detect a conservatively chosen effect size of 0.5, allowing for up to 10% drop-out.

Baseline characteristics will be reported as mean (sd) or median (IQR) for continuous measurements depending on skew. Discrete data with a small number of possible outcomes (e.g. gender) will be reported as percentages.

Continuous outcomes measured at T1, T2, T3, T4 will be modelled using linear mixed effect models (LMEs) with a random intercept to account for within-participant correlation. Treatment group, and timepoint will be included as factor variables to allow for nonlinear change over time, and an interaction term between group and time will be included to allow for different change trajectories. Analysis and visualisation of model residuals will be carried out. Transformations will be used to adjust for any detected heteroscedastic patterns with a back transformation used to report outcomes on the original scale (e.g. if a log transformation is used, results will be exponentiated back to the original scale and results will be presented as percentage change). If large outliers are detected and these are not rectified by transformations, robust LMEs will be used. If robust methods are used, any differences with the non-robust fitted models will be discussed.

Discrete (count) outcomes measure at T1, T2, T3 and T4 will be modelled using generalised LMEs, with a negative binomial model to allow for likely overdispersion. Treatment group and time will be included as factor variables (as above) and a random intercept included for participant. Model diagnostics will again be carried out via visualisation of deviance residuals.

Analysis of data collected at T1 and T4 will be carried out using ANCOVA (and generalised ANCOVA as appropriate for discrete data), with baseline (T1) and treatment groups as covariates, including interaction terms. Residuals diagnostics will again be used to detected model inadequacies, with transformations and/or robust estimators used accordingly.

All tests will be two-sided tests, and all results reports as estimates, 95% confidence intervals, and p-values. Results associated with p-values > 0.05 will not be reported as ‘no difference’, instead presented in terms of statistical significance and trends to towards such.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 318781 0
Government body
Name [1] 318781 0
Department of Health and Aged Care-Medical Research Future Fund
Country [1] 318781 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 321221 0
None
Name [1] 321221 0
Address [1] 321221 0
Country [1] 321221 0
Other collaborator category [1] 283489 0
Charities/Societies/Foundations
Name [1] 283489 0
Clinikids, The Kids Institute
Address [1] 283489 0
Country [1] 283489 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317388 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 317388 0
Ethics committee country [1] 317388 0
Australia
Date submitted for ethics approval [1] 317388 0
28/04/2025
Approval date [1] 317388 0
08/07/2025
Ethics approval number [1] 317388 0
Ethics committee name [2] 317390 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 317390 0
Ethics committee country [2] 317390 0
Australia
Date submitted for ethics approval [2] 317390 0
26/05/2025
Approval date [2] 317390 0
11/07/2025
Ethics approval number [2] 317390 0

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

Contacts
Principal investigator
Name 140898 0
Prof Alison Lane
Address 140898 0
Olga Tennison Autism Research Centre, La Trobe University, Melbourne Vic 3086
Country 140898 0
Australia
Phone 140898 0
+61 3 9479 2463
Fax 140898 0
Email 140898 0
[email protected]
Contact person for public queries
Name 140899 0
Alison Lane
Address 140899 0
Olga Tennison Autism Research Centre, La Trobe University, Melbourne Vic 3086
Country 140899 0
Australia
Phone 140899 0
+61 3 9479 2463
Fax 140899 0
Email 140899 0
[email protected]
Contact person for scientific queries
Name 140900 0
Alison Lane
Address 140900 0
Olga Tennison Autism Research Centre, La Trobe University, Melbourne Vic 3086
Country 140900 0
Australia
Phone 140900 0
+61 3 9479 2463
Fax 140900 0
Email 140900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.