Examining the Efficacy of the Anxiety Meter for Recognition and Management of Anxiety Signs in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. Primary: Does the Anxiety Meter improve awareness and management of physiological
           arousal induced by anxiogenic stimuli in a controlled setting? Hypothesis: The Anxiety
           Meter will improve awareness and management of symptoms because it promotes awareness of
           arousal - a skill which is impaired in ASD.

        2. Secondary: What demographic and cognitive and behavioural variables predict response to
           the Anxiety Meter? Hypothesis: Age, IQ, sex, and severity of anxiety symptoms at
           baseline will affect treatment response.

      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:

        1. Baseline (30 minutes): After completing the STAI, participants will watch an animated
           movie clip. This task has been used successfully as a "baseline activity" in our
           previous studies in the target population.

        2. Anxiety condition 1 (3 minutes): In this task, participants will be given 3 minutes to
           prepare a 3-minute talk. They will be told that the talk will be delivered to an
           audience of 3 strangers.

        3. Intervention (2 minutes): Both groups will use this time to reflect on their anxiety
           level and apply the relaxation technique if they feel anxious. The treatment group will
           receive a real-time display of physiological arousal on the Anxiety Meter, whereas the
           control group will not receive feedback from the device. Our previous studies indicate
           that five minutes is sufficient for the heart rate to return to baseline. Both groups
           will complete the STAI (attached) as a report of their anxiety levels before and after
           the task.

        4. Anxiety condition 2 (3 minutes): Participants will deliver a 3-minute talk to an
           audience of 3 strangers.

        5. Return-to-baseline (15 minutes): Participants will watch an animated movie clip.
    

Intervention name(s): Anxiety Meter
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment