None listed
Conditions
Brief summary
The primary aim of this study is to assess the effect of a sensory vest on autistic children’s anxiety. Using a randomised controlled trial design, Autistic children aged 8-12 years will be randomly allocated to an experimental (sensory vest) or placebo vest condition. Study participants will wear the vests for 12 weeks, attend monthly study visits with the research team and complete brief online surveys throughout. Child anxiety will be measured by assessing stress response (electrodermal activity via sweat response) during activity and parent report. The secondary aim of the study is to explore the mechanism-of-action and cost-effectiveness of the sensory vest. Specifically, we will examine a) whether the sensory vest affects anxiety symptoms directly or indirectly via sensory regulation, sleep quality and/or physical activity pathways, and b) the cost-effectiveness of sensory vest wear compared to placebo in terms of health-related quality of life from a societal perspective.
Interventions
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. Pa
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.
The sensory vest is clothing worn close to the body, generally as an undergarment. The vest 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. Pa
The sensory vest is clothing worn close to the body, generally as an undergarment. The vest 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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Healthy volunteers
No
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
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)
Outcome results
None listed