Holly™ Community Trial

NCT07312695 | Completed

• 1 other identifier: eREB#0348
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.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.
2. 2.To examine facilitators and barriers to real world implementation of holly™.

Conditions

Behavioural Responses and Emotional Reactivity

Keywords

wearable; emotion regulation; neurodevelopment disorder; anxiety

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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).

  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.

  During intervention (3-week device trial).

Other Outcomes (10)

• Relevance to Clinical Outcomes (Effectiveness) - Aberrant Behaviour Checklist (ABC-2)

  Baseline and post-intervention (up to 1 year after completion of the device trial period).

• Relevance to Clinical Outcomes (Effectiveness) - Children's Sleep Habit Questionnaire (CSHQ)

  Baseline and post-intervention (up to 1 year after completion of the device trial period). For POND study participants, baseline CSHQ collected at enrollment, or existing POND CSHQ collected within the last two years.

• Relevance to Clinical Outcomes (Effectiveness) - Emotion Dysregulation Inventory (EDI)

  Baseline and post-intervention (up to 1 year after completion of the device trial period).

Study Arms (1)

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.

Device: holly device trial

Interventions

holly device trial DEVICE

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.

holly device trial

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Strong emotional responses, such as outbursts, shutdowns, and/or meltdowns as reported by parents

You may not qualify if:

• Use of beta blockers

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Ontario Brain Institute: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

MeSH Terms

Conditions

Emotional Regulation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders

Study Officials

• Azadeh Kushki, PhD.

  Hollanf Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 31, 2025
• Study Start: April 13, 2023
• Primary Completion: July 12, 2024
• Study Completion: July 30, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)