Behavioural Responses and Emotional ReactivityNCT07312695
Holly™ Community Trial
A study testing holly device trial in people with Behavioural Responses and Emotional Reactivity, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial summary
This community study is a mixed effectiveness-implementation trial of holly™ for delivering information about arousal levels in paediatric populations. This study will evaluate the community implementation of holly™ and gather preliminary data on its impact on quality of life. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Behavioural Responses and Emotional Reactivity
- What is being tested?
- holly device trial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 13 Apr 2023to 30 Jul 2024
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Strong emotional responses, such as outbursts, shutdowns, and/or meltdowns as reported by parents
Who cannot join
- Use of beta blockers
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
About this study
Official title: A Community Trial of Holly™ for Pediatric Populations in Naturalistic Settings
This community study is a mixed effectiveness-implementation trial of holly™ for delivering information about arousal levels in paediatric populations. This study will evaluate the community implementation of holly™ and gather preliminary data on its impact on quality of life. holly™ is not meant to drive clinical decisions (diagnosis, monitoring, or intervention); instead, it is an informational tool to provide caregivers and children (where appropriate) with visualizations of arousal levels throughout the day and support children's emotional wellbeing.
For this study, the goal is to have families try out holly™ at home. The main objectives are:
Read more
- To evaluate the implementation of holly™ in community settings. Specifically, A (primary)) To evaluate the usability of holly™ in community settings; and B) To evaluate the acceptability and adoption of holly™ in community settings.
- To examine facilitators and barriers to real world implementation of holly™.
Exploratory Objective 1: To examine change (pre/post using holly™) in quality of life and mechanisms that may contribute to changes in quality of life (e.g., irritability, sleep, emotion regulation, anxiety, co-occurring symptoms).
Exploratory Objective 2: To gather preliminary data to explore associations between holly™ measurements and phenotypic and neurobiological characteristics to inform future trials and use cases.
holly™ is a patented and clinically validated algorithm for detecting emotional levels. Children will be given a study smartwatch with the holly™ application on it and asked to wear it for three weeks. Parents will get alerts and information about their child's emotional level on a study smartphone. Parents can use this information to help their child manage feelings as they happen. Parents can also use holly™ to review their child's emotion level history from the past day or days of use. Before and after using holly™, parents and children will be asked to fill out some questionnaires online. When families are finished with their three-week trial, they will be given a pre-paid shipping label to return the study devices to us.
- Being tested
- holly device trial
- Keywords
- wearable, emotion regulation, neurodevelopment disorder, anxiety
- Medical subject headings
- Emotional Regulation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holly device trialDevice
Children will be given a study smartwatch with the holly™ app on it and asked to wear it for three weeks. Parents will get alerts and information about their child's emotional level on a study smartphone. Parents can use this information to help their child manage feelings as they happen. Parents can also use holly™ to review their child's emotion level history from the past day or days of use. Using holly, caregivers and children (where appropriate) will be provide with visualizations of arousal levels throughout the day and can be used to support children's emotional wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| holly device trial | Experimental | Families try out holly™ at home, where the children will be given a study smartwatch with the holly™ app on it and asked to wear it for three weeks. Parents will get alerts and information about their child's emotional level on a study smartphone. Parents can use this information to help their child manage feelings as they happen. Parents can also use holly™ to review their child's emotion level history from the past day or days of use. Receives: Device: holly device trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability - System Usability Scale (SUS)
To evaluate the usability of holly™ in community settings, the investigators will employ a summative evaluation approach through questionnaires. The primary measure will be the System Usability Scale (SUS), a 10-item parent questionnaire generating a score from 0-100 where higher is better. The criteria for success is an average score of 74 or higher on the SUS across the participants as per normative data for the SUS. Caregivers complete the measure following device usage.
Measured: Post-intervention (up to 1 year after completion of the device trial period)
Usability - Post-Study System Usability Questionnaire (PSSUQ)
The Post-Study System Usability Questionnaire (PSSUQ) is a 16-item questionnaire that probes overall usability, system usefulness, information quality, and interface quality with acceptable estimated reliabilities of 0.83 to 0.96. Caregivers complete the measure following device usage.
PSSUQ follows a 7-point Likert Scale (+ NA option). The overall result is calculated by averaging the scores from the 7 points of the scale. It has three sub-scales: system usefulness, information quality, and interface quality. The overall score can range from 1-7. The lower the score, the better the performance and satisfaction.
Measured: Post-intervention (up to 1 year after completion of the device trial period)
Usability - Custom Usability Questionnaire
Children will complete a custom usability questionnaire assessing likeability and comfort of the smartwatch. The measure uses a visual Likert-type scale consisting of 3 items scored from 1 (lowest) to 3 (highest), with higher scores indicating better usability outcomes.
Measured: Post-intervention (up to 1 year after completion of the device trial period)
Acceptability and Adoption - Custom Parent Questionnaire
The Custom Parent Questionnaire will measure users' intention to use holly™ after completion of the study, and extent to which holly™ was integrated in the users' lives, measured as the number of settings where holly™ is used during the trial (home, school, community). Caregivers complete the questionnaire following device usage.
Measured: Post-intervention (up to 1 year after completion of the device trial period)
Acceptability and Adoption - Client Satisfaction Questionnaire (CSQ-8)
Acceptance, operationalized as the users' degree of satisfaction with holly™ and quantified using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measure with high coefficients of internal consistency reliability (Cronbach's alpha of 0.80 or greater) and adequate validity. The instrument will be modified to include a description of the holly™ "service". Total scores range from 8 to 32, with the higher number indicating greater satisfaction. Caregivers complete the measure following device usage.
Measured: Post-intervention (up to 1 year after completion of the device trial period)
Acceptability and Adoption - Adapted version of the Barriers to Treatment Participation Scale
To measure appropriateness, defined as the perceived fit, relevance, and compatibility of holly™ within the users' context, the investigators will be using an adapted version of the Barriers to Treatment Participation Scale, which demonstrates good psychometric properties regarding reliability and structure (internal consistency Cronbach's alpha of 0.85 or greater) and is reasonably valid. Caregivers complete this 32-item questionnaire rating of how much they agree with statements about their expectancies of barriers to treatment participation for their child, using a 5-point Likert scale (1=totally disagree, 5= totally agree). The total score ranges from 32 - 160, with higher score indicating greater barriers (i.e., worse outcome).
Measured: Post-intervention (up to 1 year after completion of the device trial period)
Acceptability and Adoption - Usage logs
The investigators will measure the number of hours holly™ is worn during the three-week trial, and rate of change in usage from week 1 to week 3. This information will be recorded by hollyTM.
Measured: During intervention (3-week device trial).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start13 Apr 2023
- Primary completion12 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioural Responses and Emotional ReactivityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute
- Responsible party
- Principal investigator, Azadeh Kushki, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Azadeh Kushki, PhD., Principal investigator, Hollanf Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312695
- Sponsor's protocol ID
- eREB#0348
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Trial of Holly™ for Pediatric Populations in Naturalistic Settings
- ClinicalTrials.gov ID
- NCT07312695
- Acronym / sponsor ID
- eREB#0348
- Keywords
- wearable, emotion regulation, neurodevelopment disorder, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Ontario Brain Institute
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 31 Dec 2025 (actual)
- 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.
This community study is a mixed effectiveness-implementation trial of holly™ for delivering information about arousal levels in paediatric populations. This study will evaluate the community implementation of holly™ and gather preliminary data on its impact on quality of life. holly™ is not meant to drive clinical decisions (diagnosis, monitoring, or intervention); instead, it is an informational tool to provide caregivers and children (where appropriate) with visualizations of arousal levels throughout the day and support children's emotional wellbeing.
For this study, the goal is to have families try out holly™ at home. The main objectives are:
- To evaluate the implementation of holly™ in community settings. Specifically, A (primary)) To evaluate the usability of holly™ in community settings; and B) To evaluate the acceptability and adoption of holly™ in community settings.
- To examine facilitators and barriers to real world implementation of holly™.
Exploratory Objective 1: To examine change (pre/post using holly™) in quality of life and mechanisms that may contribute to changes in quality of life (e.g., irritability, sleep, emotion regulation, anxiety, co-occurring symptoms).
Exploratory Objective 2: To gather preliminary data to explore associations between holly™ measurements and phenotypic and neurobiological characteristics to inform future trials and use cases.
holly™ is a patented and clinically validated algorithm for detecting emotional levels. Children will be given a study smartwatch with the holly™ application on it and asked to wear it for three weeks. Parents will get alerts and information about their child's emotional level on a study smartphone. Parents can use this information to help their child manage feelings as they happen. Parents can also use holly™ to review their child's emotion level history from the past day or days of use. Before and after using holly™, parents and children will be asked to fill out some questionnaires online. When families are finished with their three-week trial, they will be given a pre-paid shipping label to return the study devices to us.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| holly device trial | Experimental | Device: holly device trialFamilies try out holly™ at home, where the children will be given a study smartwatch with the holly™ app on it and asked to wear it for three weeks. Parents will get alerts and information about their child's emotional level on a study smartphone. Parents can use this information to help their child manage feelings as they happen. Parents can also use holly™ to review their child's emotion level history from the past day or days of use. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Strong emotional responses, such as outbursts, shutdowns, and/or meltdowns as reported by parents
Key exclusion criteria (1 listed)
- Use of 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 |
|---|---|---|
| holly device trialChildren will be given a study smartwatch with the holly™ app on it and asked to wear it for three weeks. Parents will get alerts and information about their child's emotional level on a study smartphone. Parents can use this information to help their child manage feelings as they happen. Parents can also use holly™ to review their child's emotion level history from the past day or days of use. Using holly, caregivers and children (where appropriate) will be provide with visualizations of arousal levels throughout the day and can be used to support children's emotional wellbeing. | Device | holly device trial |
Primary outcome
Usability - System Usability Scale (SUS)
Time frame: Post-intervention (up to 1 year after completion of the device trial period)
To evaluate the usability of holly™ in community settings, the investigators will employ a summative evaluation approach through questionnaires. The primary measure will be the System Usability Scale (SUS), a 10-item parent questionnaire generating a score from 0-100 where higher is better. The criteria for success is an average score of 74 or higher on the SUS across the participants as per normative data for the SUS. Caregivers complete the measure following device usage.
Usability - Post-Study System Usability Questionnaire (PSSUQ)
Time frame: Post-intervention (up to 1 year after completion of the device trial period)
The Post-Study System Usability Questionnaire (PSSUQ) is a 16-item questionnaire that probes overall usability, system usefulness, information quality, and interface quality with acceptable estimated reliabilities of 0.83 to 0.96. Caregivers complete the measure following device usage. PSSUQ follows a 7-point Likert Scale (+ NA option). The overall result is calculated by averaging the scores from the 7 points of the scale. It has three sub-scales: system usefulness, information quality, and interface quality. The overall score can range from 1-7. The lower the score, the better the performance and satisfaction.
Usability - Custom Usability Questionnaire
Time frame: Post-intervention (up to 1 year after completion of the device trial period)
Children will complete a custom usability questionnaire assessing likeability and comfort of the smartwatch. The measure uses a visual Likert-type scale consisting of 3 items scored from 1 (lowest) to 3 (highest), with higher scores indicating better usability outcomes.
Acceptability and Adoption - Custom Parent Questionnaire
Time frame: Post-intervention (up to 1 year after completion of the device trial period)
The Custom Parent Questionnaire will measure users' intention to use holly™ after completion of the study, and extent to which holly™ was integrated in the users' lives, measured as the number of settings where holly™ is used during the trial (home, school, community). Caregivers complete the questionnaire following device usage.
Acceptability and Adoption - Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-intervention (up to 1 year after completion of the device trial period)
Acceptance, operationalized as the users' degree of satisfaction with holly™ and quantified using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measure with high coefficients of internal consistency reliability (Cronbach's alpha of 0.80 or greater) and adequate validity. The instrument will be modified to include a description of the holly™ "service". Total scores range from 8 to 32, with the higher number indicating greater satisfaction. Caregivers complete the measure following device usage.
Acceptability and Adoption - Adapted version of the Barriers to Treatment Participation Scale
Time frame: Post-intervention (up to 1 year after completion of the device trial period)
To measure appropriateness, defined as the perceived fit, relevance, and compatibility of holly™ within the users' context, the investigators will be using an adapted version of the Barriers to Treatment Participation Scale, which demonstrates good psychometric properties regarding reliability and structure (internal consistency Cronbach's alpha of 0.85 or greater) and is reasonably valid. Caregivers complete this 32-item questionnaire rating of how much they agree with statements about their expectancies of barriers to treatment participation for their child, using a 5-point Likert scale (1=totally disagree, 5= totally agree). The total score ranges from 32 - 160, with higher score indicating greater barriers (i.e., worse outcome).
Acceptability and Adoption - Usage logs
Time frame: During intervention (3-week device trial).
The investigators will measure the number of hours holly™ is worn during the three-week trial, and rate of change in usage from week 1 to week 3. This information will be recorded by hollyTM.
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 31 Dec 2025.
- Individual participant dataSharing planned: No
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
Hollanf 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 holly device trial in people with Behavioural Responses and Emotional Reactivity, 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 1 inclusion and 1 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 31 Dec 2025. 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?
Usability - System Usability Scale (SUS) (time frame: Post-intervention (up to 1 year after completion of the device trial period)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.