Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2023-04-13
2024-07-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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holly device trial
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.
holly device trial
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.
Interventions
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holly device trial
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Years
21 Years
ALL
No
Sponsors
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Holland Bloorview Kids Rehabilitation Hospital
OTHER
Ontario Brain Institute
OTHER
Responsible Party
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Azadeh Kushki
Senior Scientist
Principal Investigators
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Azadeh Kushki, PhD.
Role: PRINCIPAL_INVESTIGATOR
Hollanf Bloorview Kids Rehabilitation Hospital
Locations
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Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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eREB#0348
Identifier Type: -
Identifier Source: org_study_id