A Community Trial of Holly™ for Pediatric Populations in Naturalistic Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Usability - System Usability Scale (SUS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Strong emotional responses, such as outbursts, shutdowns, and/or meltdowns as reported by parents
排除标准
- •Use of beta blockers
结局指标
主要结局
Usability - System Usability Scale (SUS)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Azadeh Kushki
Senior Scientist
Holland Bloorview Kids Rehabilitation Hospital