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临床试验/NCT06664944
NCT06664944
已完成
不适用

Technology Exposure and Child Health: Wellness Impact and Social Effects (TECHWISE): An Observational Product Registry Study

Aura1 个研究点 分布在 1 个国家目标入组 912 人2024年11月15日

概览

阶段
不适用
干预措施
Children 8-17 years old
疾病 / 适应症
未指定
发起方
Aura
入组人数
912
试验地点
1
主要终点
Assess ongoing technology use to explore children's online behaviors and derived health behaviors.
状态
已完成
最后更新
17天前

概览

简要总结

The goal of this study is to understand how children's mobile device usage (smartphones or tablets), including social media use and online games, are related to their mental wellness and mental health, as well as some aspects of their physical activity and sleep. This study is available to all children between the ages of 8 and 17 years and a parent/caregiver.

Researchers will compare participant mobile device usage with their survey responses on sleep, stress, mental health, and physical activity, as well as their parent/caregiver's survey responses.

Participants will:

  • run the Aura app with parental controls on their dedicated mobile device
  • complete monthly surveys
  • answer daily questions on mood, stress, sleep and physical activity

The study is fully virtual. Duration is 3 months.

详细描述

Once enrolled, child participants will use their mobile devices as usual, and Aura will collect data on on-line and off-line activity, app usage, social interaction, sleep, location and activity levels. The child participant will complete surveys on a monthly basis, including: * A range of questionnaires about feelings and behaviors that are associated with mental health challenges * Questionnaires that ask about well-being and positive feelings, including relationships with family and friends * Questionnaires that ask about experiences with social media and device usage * A questionnaire about feelings of loneliness * A questionnaire that asks about activity sleep In parallel, the parent participant will complete monthly surveys about the child, including: * Medical history and changes * A range of questionnaires about feelings and behaviors that are associated with mental health challenges * Questionnaires that ask about well-being and positive feelings, including relationships with family and friends

注册库
clinicaltrials.gov
开始日期
2024年11月15日
结束日期
2026年4月13日
最后更新
17天前
研究类型
Observational
性别
All

研究者

发起方
Aura
责任方
Sponsor

入排标准

入选标准

  • Child participants are male, female, non-binary persons, ages 8-17, inclusive
  • Parent/Authorized Legal Guardian willing to provide informed consent; child willing to provide assent
  • Both Parent/Authorized Legal Guardian and child own a mobile device that already has the Aura app or is able to install and run the Aura app, and the appropriate parental control features.
  • Parent/Authorized Legal Guardian and child are willing for child to use a dedicated device for the duration of the study (ie., child cannot share device with a sibling or other family member).
  • Multiple children from the same family are eligible to participate, provided that each enrolled child uses a dedicated device AND is able to complete outcome assessments independently, AND that parent/authorized legal guardian is able to complete assessments for each enrolled child.
  • Both Parent/Authorized Legal Guardian and child willing to share data collected as part of the Aura app and related device applications
  • Consented Parent/Authorized Legal Guardian and child maintain active Aura accounts throughout their study participation
  • Consented Parent/Authorized Legal Guardian and child are able to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
  • Consented Parent/Authorized Legal Guardian and child are to comply with all testing and study requirements

排除标准

  • 未提供

研究组 & 干预措施

Children 8-17 years old

Over 84% of children ages 8 and up have access to a mobile device (smartphone, tablet) and are active on social media. This study focuses on children ages 8-17 to better understand social media usage and how it relates to their mental well-being.

结局指标

主要结局

Assess ongoing technology use to explore children's online behaviors and derived health behaviors.

时间窗: December 2025

Assess ongoing technology use via the Aura app, including social media and other online behaviors, as well as other smartphone derived health behaviors, such as sleep, location, and activity levels.

次要结局

  • Examine bivariate associations between technology use features and mental wellness and mental health outcomes(December 2025)
  • Develop preliminary predictive models that use technology use and smartphone-derived parameters to predict point-in-time mental health outcomes(December 2025)

研究点 (1)

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