Holly™ Community Trial

Holland Bloorview Kids Rehabilitation Hospital

Status: Completed

Conditions: Behavioural Responses and Emotional Reactivity

Treatments: Device: holly device trial

Study type: Interventional

Funder types: Other

Identifiers

NCT07312695

eREB#0348

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 4 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Use of beta blockers

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

holly device trial

Experimental group

Description:

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.

Treatment:

Device: holly device trial