Trial Review

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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
Kingsbury Drive, Bundoora VIC 3086
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
This study will test the use of JettProof sensory singlets among children with a diagnosis of Autism Spectrum Disorder. The primary objective of this trial is to evaluate the effects of JettProof sensory singlets – applied for at least 6 hours/day for a three-week period – on the self-regulatory and motor functioning of autistic children. We hypothesise that application of the JettProof sensory singlet will lead to a reduction in autonomic and behavioural markers of affective and motor dysregulation and the subsequent attainment of individualized goals, relative to standard care.

A second objective is to evaluate the effects of JettProof sensory singlets on additional outcomes related to sensory and motor functioning difficulties for autistic children and their caregivers. We hypothesize that, for children, the application of the JettProof sensory singlet will lead to a reduction in anxiety, less negative and more positive daily affect, and improvements in sleep quality for children and, for caregivers, a reduction in the levels of stress and perceived effort required to assist their children.

A third objective is to assess the feasibility and acceptability of implementing JettProof sensory singlets with autistic children. We anticipate that most children will wear the singlet for 6 hours/day or more during the full-scale intervention phase, and report that it is at least tolerable.

A fourth, exploratory objective is to determine whether there may be sensory characteristics of autistic children that predict differential response to JettProof sensory garments. We hypothesize that JettProof sensory singlets will evidence greater efficacy among children with a dysfunction in proprioceptive and/or vestibular sensory systems.


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
Prof 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
Prof 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
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