Autism Spectrum DisorderNCT02160691
Examining the Efficacy of the Anxiety Meter for Recognition and Management of Anxiety Signs in Autism Spectrum Disorder
A study testing Anxiety Meter in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Anxiety Meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 8-18 years of age.
- Primary diagnosis of autism spectrum disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- Full-scale intelligence quotient (IQ) >50.
- Must be able to complete tasks and the relaxation technique. A participant will be deemed able to do the public speaking task if he/she is able to complete Modules 3 or 4 of the Autism Diagnostic Observation Schedule (ADOS) protocol.
- Must show physiological arousal in response to anxiety-inducing stimulus (minimum 2 beats/minute increase in heart rate).
Who cannot join
- Started other treatments within four weeks at the time of the study.
- Completed Cognitive Behavioural Therapy in the past.
- Using beta-blockers.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
About this study
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.
Read the 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:
- 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.
- 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:
- 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.
- 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.
- 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.
- Anxiety condition 2 (3 minutes): Participants will deliver a 3-minute talk to an audience of 3 strangers.
- Return-to-baseline (15 minutes): Participants will watch an animated movie clip.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Anxiety Meter
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety MeterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Anxiety Meter |
| No Anxiety Meter | No intervention | The control group will have the Anxiety Meter during the intervention period, but the marker will not move. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startOct 2015
- Primary completionAug 2020
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azadeh Kushki, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Azadeh Kushki, PhD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160691
- Sponsor's protocol ID
- ANXMT_RCT1
- Status last verified
- Jan 2022
- First submitted
- 5 Jun 2014
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34775994
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of the Anxiety Meter for Recognition and Management of Anxiety Signs in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02160691
- Acronym / sponsor ID
- ANXMT_RCT1
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- 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.
- 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.
- 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.
- Anxiety condition 2 (3 minutes): Participants will deliver a 3-minute talk to an audience of 3 strangers.
- Return-to-baseline (15 minutes): Participants will watch an animated movie clip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety Meter | Experimental | Device: Anxiety MeterThe 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children 8-18 years of age.
- Primary diagnosis of autism spectrum disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- Full-scale intelligence quotient (IQ) >50.
- Must be able to complete tasks and the relaxation technique. A participant will be deemed able to do the public speaking task if he/she is able to complete Modules 3 or 4 of the Autism Diagnostic Observation Schedule (ADOS) protocol.
- Must show physiological arousal in response to anxiety-inducing stimulus (minimum 2 beats/minute increase in heart rate).
Key exclusion criteria (3 listed)
- Started other treatments within four weeks at the time of the study.
- Completed Cognitive Behavioural Therapy in the past.
- Using beta-blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety MeterThis 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. | Device | Anxiety Meter |
Primary outcome
Proportion of responders
Time frame: Week 4
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.
2 secondary outcomes
Change in heart rate
Time frame: Week 4
Change in self-reported anxiety level
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 34775994Nguyen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azadeh Kushki, PhD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Meter in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02160691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.