NCT02160691

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

June 5, 2014

Last Update Submit

January 18, 2022

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in heart rate

    Week 4

  • Change in self-reported anxiety level

    Week 4

Study Arms (2)

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.

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.

Interventions

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.

Anxiety Meter

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Started other treatments within four weeks at the time of the study.
  • Completed Cognitive Behavioural Therapy in the past.
  • Using beta-blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34775994DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Azadeh Kushki, PhD

    Holland Bloorview Kids Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 11, 2014

Study Start

October 1, 2015

Primary Completion

August 1, 2020

Study Completion

November 1, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

CA(1)