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Trial registered on ANZCTR


Registration number
ACTRN12622001244796
Ethics application status
Approved
Date submitted
26/08/2022
Date registered
14/09/2022
Date last updated
14/09/2022
Date data sharing statement initially provided
14/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of JettProof Sensory Singlets for Autistic Children
Scientific title
Effectiveness of JettProof Sensory Singlets for Self-Regulatory and Motor Functioning in Autistic Children: A Single Case Series
Secondary ID [1] 307662 0
nil
Universal Trial Number (UTN)
U1111-1280-9257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 327187 0
Condition category
Condition code
Mental Health 324325 324325 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention delivered in this trial is a JettProof sensory singlet composed of CalmTex® – a polyester and elastane sensory fabric that is breathable and moisture wicking, with a 360-degree knitted stretch that moves with the body. JettProof sensory singlets are intended to be fitted closely to the body and worn as a base garment or under other clothing.

This trial will utilize a single-subject A-B-A design over a period of 5 weeks. Week 1 is a pre-intervention/baseline phase (A) whereby children will continue receiving standard care or ‘treatment as usual’ -- defined as as any interventions (e.g., medications, behavioural therapies) the child was receiving prior to enrolment in the trial. Week 2 is a pre-intervention/acclimatization phase (B) allowing children to practice wearing the singlet and increase the duration of daily use in their own time before proceeding to full-scale wearing; a fixed schedule of acclimatization will not be imposed. The researcher will telephone the caregiver during this phase to identify and troubleshoot any issues arising. Weeks 3 and 4 represent the full-scale intervention phase (B) whereby children are encouraged to wear their singlet for at least 6 hours/day. There will be no restrictions regarding wearing times or contexts, nor regarding access to outside care or interventions (including medications), during the intervention phases. Week 5 is a post-intervention/return-to-baseline phase (A) whereby children will cease wearing their singlet and return to standard care or ‘treatment as usual’.
Intervention code [1] 324123 0
Treatment: Devices
Intervention code [2] 324124 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332124 0
Child sympathetic nervous system activity (i.e., heart rate, heart rate variability, electrodermal activity, and motion-based activity) acquired from an Empatica E4 wristband, worn in the context of Laboratory Temperament Assessment Battery (Lab-TAB; Goldsmith et al., 2010) episodes.
Timepoint [1] 332124 0
Measured on five occasions: during the pre-intervention/baseline phase (Week 1), during each week of the intervention phase (Weeks 2-4), and during the post-intervention/return to baseline phase (Week 5).
Primary outcome [2] 332125 0
Child motor coordination as measured by the standardized Movement Assessment Battery for Children-2nd Edition (M-ABC-2; Henderson, Sugden, & Barnett, 2007).
Timepoint [2] 332125 0
Measured on two occasions: during the pre-intervention/baseline phase (Week 1) and during the post-intervention/return to baseline phase (Week 5).
Primary outcome [3] 332126 0
Child motor coordination as measured by the Clinical Observations of Motor and Postural Skills (COMPS-2; B Wilson, Kaplan, Pollock, & Law, 2000).
Timepoint [3] 332126 0
Measured on two occasions: during the pre-intervention/baseline phase (Week 1) and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [1] 412299 0
Child attainment of individualized and meaningful intervention goals as measured by Goal Attainment Scaling (GAS; Kiresuk & Lund, 1994).
Timepoint [1] 412299 0
Measured on two occasions: during the pre-intervention/baseline phase (Week 1) and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [2] 412300 0
Child anxiety as measured by the caregiver-reported Spence Children’s Anxiety Scale-Parent Version (SCAS-P; Nauta et al., 2004).
Timepoint [2] 412300 0
Measured on two occasions: during the pre-intervention/baseline phase (Week 1) and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [3] 412301 0
Child daily affect reported by caregivers via smartphone-based experience sampling.
Timepoint [3] 412301 0
Measured three times per day for the five week duration of the trial, spanning pre-intervention/baseline (Week 1), intervention (each of Weeks 2-4), and post-intervention/return to baseline (Week 5) phases.
Secondary outcome [4] 413576 0
Child nightly sleep reported by caregivers via smartphone-based experience sampling.
Timepoint [4] 413576 0
Measured three times per day for the five week duration of the trial, spanning pre-intervention/baseline (Week 1), intervention (each of Weeks 2-4), and post-intervention/return to baseline (Week 5) phases.
Secondary outcome [5] 413577 0
Child self-regulation as coded from behaviour during semi-structured Lab-TAB (Goldsmith et al., 2010) episodes.
Timepoint [5] 413577 0
Measured on five occasions: during the pre-intervention/baseline phase (Week 1), during each week of the the intervention phase (Weeks 2-4), and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [6] 413578 0
Child reactivity as coded from behaviour during semi-structured Lab-TAB (Goldsmith et al., 2010) episodes.
Timepoint [6] 413578 0
Measured on five occasions: during the pre-intervention/baseline phase (Week 1), during each week of the intervention phase (each of Weeks 2-4), and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [7] 413579 0
Caregiver stress as measured by the Parent Stress Index-4th Edition Short Form (PSI-4-SF; Abiden, 2012).
Timepoint [7] 413579 0
Measured on two occasions: during the pre-intervention/baseline phase (Week 1) and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [8] 413580 0
Caregiver effort expended to support their child as measured by the Parent Effort Scale (PES; Pfeiffer et al., 2017).
Timepoint [8] 413580 0
Measured on two occasions: during the pre-intervention/baseline phase (Week 1) and during the post-intervention/return to baseline phase (Week 5).
Secondary outcome [9] 413581 0
Composite feasibility/acceptability of the intervention, indicated from duration of daily singlet wear reported by caregivers via smartphone-based experience sampling.
Timepoint [9] 413581 0
Measured three times per day for the five week duration of the trial, spanning pre-intervention/baseline (Week 1), intervention (each of Weeks 2-4), and post-intervention/return to baseline (Week 5) phases.
Secondary outcome [10] 413582 0
Composite feasibility/acceptability of the intervention, indicated through semi-structured interviews.
Timepoint [10] 413582 0
Measured on two occasions: pre-intervention at trial entry (Week 0) and during the post-intervention/return to baseline phase (Week 5).

Eligibility
Key inclusion criteria
1. Age between 4 years 0 months and 11 years 11 months 30/31 days at trial entry, and
2. DSM-5 clinical diagnosis of Autism Spectrum Disorder or equivalent DSM-IV diagnosis of Asperger’s Disorder or Autism, and
3. Social Responsiveness Scale-2nd Edition (SRS-2; Constantino & Gruber, 2012) total t score exceeding the cutpoint value of 60 associated with Autism Spectrum Disorder, and
4. Short Sensory Profile (SSP; McIntosh, Miller, Shyu, & Dunn, 1999) total score more than two standard deviations below the normative mean, and
5. Caregiver has a smartphone (iPhone or Android).
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or previous use of JettProof sensory singlets and/or other garments designed for sensory-based needs, and/or
2. Insufficient language and/or communication skills to understand and assent to study procedures and indicate their discomfort reliably as indicated by the caregiver report Pragmatics Profile of Everyday Communication Skills (PPECS; Dewart & Summers, 1995) denoting children’s every day and flexible use of language for a range of relevant functions: making requests for assistance, expressing upset, giving information, and asserting independence.

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
OUTCOME ANALYSES
This single-case feasibility study will combine visual and quantitative analyses of the data. For each participant, scores for each repeated outcome measure (i.e., Empatica E4 recordings, Lab-Tab, GAS, PES-H, PES-C, PSI-4-SF) will be graphically depicted as a time-series with standard deviation bands around each series and the global average for each outcome measure plotted as a reference line. Visual analysis will be employed for an initial examination of within-subject slope and level change across trial phases. Effect sizes will be computed through parametric methods (i.e., standard mean difference [Hedges g]) and non-overlap indices (e.g., Tau-U), with a p-value of < .05 indicative of statistical significance.

ADDITIONAL ANALYSES
The sample will be characterized using descriptive methods (Demographic and Medical History Questionnaire, PPECS) and standard/raw scores (SSP, Vineland-3, M-ABC-2). Feasibility and acceptability of the intervention will be determined by participants’ daily duration of singlet wear and qualitative responses to the semi-structured interview conducted post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/09/2022
Actual
Date of last participant enrolment
Anticipated
24/10/2022
Actual
Date of last data collection
Anticipated
19/11/2022
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312133 0
Government body
Name [1] 312133 0
AusIndustry
Country [1] 312133 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 313408 0
Government body
Name [1] 313408 0
AusIndustry
Address [1] 313408 0
111 Bourke St, Melbourne VIC 3000
Country [1] 313408 0
Australia
Secondary sponsor category [2] 313422 0
Commercial sector/Industry
Name [2] 313422 0
Indasun Pty Ltd
Address [2] 313422 0
PO Box 5281, Kahibah NSW 2290
Country [2] 313422 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311361 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 311361 0
Ethics committee country [1] 311361 0
Australia
Date submitted for ethics approval [1] 311361 0
01/04/2022
Approval date [1] 311361 0
30/05/2022
Ethics approval number [1] 311361 0
HEC22083

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

Contacts
Principal investigator
Name 120838 0
Prof Alison E Lane
Address 120838 0
Olga Tennison Autism Research Centre, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
Country 120838 0
Australia
Phone 120838 0
+61 03 9479 1956
Fax 120838 0
Email 120838 0
[email protected]
Contact person for public queries
Name 120839 0
Alison E Lane
Address 120839 0
Olga Tennison Autism Research Centre, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
Country 120839 0
Australia
Phone 120839 0
+61 03 9479 1956
Fax 120839 0
Email 120839 0
[email protected]
Contact person for scientific queries
Name 120840 0
Alison E Lane
Address 120840 0
Olga Tennison Autism Research Centre, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
Country 120840 0
Australia
Phone 120840 0
+61 03 9479 1956
Fax 120840 0
Email 120840 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16896Study protocol    384445-(Uploaded-26-08-2022-15-08-46)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.