None listed
Conditions
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.
Interventions
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 c
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’.
Sponsors
La Trobe University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 11 Years
Healthy volunteers
No
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).
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.
Outcome results
None listed