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The purpose of the study is to determine if a new device, called the Anxiety Meter, improves recognition and management of psychological arousal associated with anxiety in children with ASD.
Anxiety is a prevalent, persistent, and disabling co-morbidity of autism spectrum disorder (ASD). In addition to its profound negative impact on physical and mental health, anxiety interacts with the core deficits of ASD to exacerbate symptomatology and increase functional impairment. Anxiety treatments efficacious in non-ASD children (e.g., Cognitive-Behavioural Therapy (CBT)) often have reduced potency and limited applicability in the ASD population due to impairments in cognitive ability, communication, emotional awareness, and introspection. Despite the urgency to treat co-morbid anxiety in ASD, there is limited evidence supporting treatment programs in higher-functioning individuals, and no evidence for those who are lower-functioning. In light of the urgent need for treatment of co-morbid anxiety in ASD and the paucity of evidence in this area, the investigators propose a study to establish early evidence on a technology-supported treatment of anxiety in children with ASD. This approach aims to reduce ASD-related barriers to treatment (e.g., deficits in emotional awareness and introspection) by providing children with a visual, real time display of their arousal level.
The proposed treatment focuses on the physiological arousal associated with anxiety. In particular, the investigators propose to use a physiological indicator of anxiety that can objectively measure and promote awareness of physiological arousal. To this end, the investigators have developed the Anxiety Meter, a device that measures arousal-related increases in heart rate using non-invasive wearable sensors and translates these to a visual display of the child's arousal level on a tablet computer. The investigators research questions are:
To investigate the above questions, the investigators propose a randomized controlled trial comparing the Anxiety Meter to a control condition in children with ASD. Both the treatment and control groups will be taught a relaxation technique (three training sessions) and will be asked to apply the technique in a controlled anxiety-inducing task (one testing session). During the testing session, participants will be seated in front of a computer screen and will complete five tasks:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anxiety Meter | Experimental | The Anxiety Meter (experimental) group will receive a real-time display of physiological arousal on the Anxiety Meter during the intervention period in visit #4. |
|
| No Anxiety Meter | No Intervention | The control group will have the Anxiety Meter during the intervention period, but the marker will not move. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anxiety Meter | Device | This is a new device developed to measure changes in heart rate and translate these into a visual display of arousal level in children with autism spectrum disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders | We hypothesize that the proposed intervention will improve the recognition of arousal signs. To examine this hypothesis, our primary outcome measure is the proportion of participants initiating diaphragmatic breathing during the intervention period. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate | We also hypothesis that the intervention will improving the potency of the relaxation technique through enhancing the participant's ability to sustain the breathing until relaxation is achieved. To examine this hypothesis, we will examine the difference in average heart rate between the anxiety (public speaking preparation) and post-intervention periods (public speaking delivery). Heart rate will be obtained from an electrocardiogram (ECG) sensor from Shimmer Research. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Azadeh Kushki, PhD | Holland Bloorview Kids Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G1R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34775994 | Derived | Nguyen J, Cardy RE, Anagnostou E, Brian J, Kushki A. Examining the effect of a wearable, anxiety detection technology on improving the awareness of anxiety signs in autism spectrum disorder: a pilot randomized controlled trial. Mol Autism. 2021 Nov 14;12(1):72. doi: 10.1186/s13229-021-00477-z. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Week 4 |
| Change in self-reported anxiety level | To further examine the hypothesis that the intervention improves symptom management, change in self-reported anxiety level measured by the State-Trait Anxiety Inventory will be examined.The change will be measured between reports obtained before and after the intervention period. | Week 4 |