Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:51 AM
Study NCT ID:
NCT07312695
Status:
COMPLETED
Last Update Posted:
2025-12-31
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holly™ Community Trial
Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Organization:
Study Overview
Official Title:
A Community Trial of Holly™ for Pediatric Populations in Naturalistic Settings
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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. 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.
For this study, the goal is to have families try out holly™ at home. The main objectives are:
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. 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: