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技术影响与儿童健康:健康影响和社会效应(TECHWISE):一项前瞻性、观察性、真实世界研究的方案

Technology Effects and Child Health: Wellness Impact and Social Effects (TECHWISE): Protocol for a Prospective, Observational, Real-World Study.

作者信息

Kollins Scott H, Flannery Jessica, Goetz Karen, Akre-Bhide Samir

机构信息

Aura Sub, LLC, Boston, NC, United States.

出版信息

JMIR Res Protoc. 2025 Jun 19;14:e69358. doi: 10.2196/69358.

DOI:10.2196/69358
PMID:40424191
Abstract

BACKGROUND

There has been controversy over the extent to which technology use in general-and social media exposure specifically-may be associated with adverse youth mental health outcomes. To date, studies have generally been small and exploratory, relying on youth self-reports to characterize technology and social media use patterns. The goal of this study is to explore the associations between objectively collected data, gathered through a commercially available app, and youth mental health outcomes.

OBJECTIVE

The broad goal of this study is to characterize the association between objectively measured technology/social media use and a range of mental health-related outcomes. Three specific aims will be initially addressed. First, we aim to quantify the association between objectively measured smartphone use and measures of well-being. Second, we aim to differentiate types of engagement-specifically, the types of content consumed versus the overall time spent on the device-and examine their association with outcomes. Third, we aim to identify moderating factors, such as age, gender, and socioeconomic status, that might influence these relationships. A secondary broad objective of this research is to establish a freely available data resource that can be accessed by qualified investigators to address a much wider range of questions in the future.

METHODS

Up to 1000 male, female, and nonbinary youth aged 8-17 years (inclusive), along with their primary caregivers, will be enrolled in the study. Youth participants must have their own dedicated iOS- or Android-based smartphone or tablet, and both they and their parents must be willing and able to download and install the data collection app on their devices. The study is open to all US-based participants who meet these 2 criteria. Following electronic consent (eConsent), participants and their caregivers will complete a range of baseline measures electronically, including assessments of psychiatric and social functioning, as well as measures of loneliness, digital stress, and disordered eating. Caregivers will be asked to provide information on the participant's health and mental health history. Youth and caregivers will then complete a similar battery of assessments 1, 2, and 3 months after baseline. Youth participants will also respond to daily questions about their mood, stress, physical activity, and sleep. Both youth and their caregivers will be compensated for completing measures at each time point. The data collection app gathers a wide range of daily data from the participant's device, including temporal patterns of use, the number and frequency of various app usage, social interactions within apps, and keystroke data. A variety of analytic methods will be used to address key questions related to how technology and social media use are associated with mental health and wellness outcomes.

RESULTS

Enrollment for this study began on November 13, 2024. As of May 20, 2025, a total of 106 participants and their caregivers had consented to participate and provided baseline data. An additional 203 children and parents have consented and are currently undergoing eligibility verification and enrollment. Initial data analysis is anticipated to begin in late autumn 2025 or winter 2026, with the expected publication of initial findings in spring 2026.

CONCLUSIONS

This study will be among the largest to date to collect both objective device usage data and validated, clinically relevant outcome measures. In accordance with our data-sharing policies, any qualified investigator will be able to access the study data, provided appropriate steps are followed.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06664944; https://clinicaltrials.gov/ct2/show/NCT06664944.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69358.

摘要

背景

在一般技术使用,特别是社交媒体接触,在多大程度上可能与青少年心理健康不良结果相关这一问题上一直存在争议。迄今为止,研究通常规模较小且具有探索性,依靠青少年自我报告来描述技术和社交媒体使用模式。本研究的目的是探讨通过一款商业应用程序客观收集的数据与青少年心理健康结果之间的关联。

目的

本研究的总体目标是描述客观测量的技术/社交媒体使用与一系列心理健康相关结果之间的关联。最初将解决三个具体目标。第一,我们旨在量化客观测量的智能手机使用与幸福感指标之间的关联。第二,我们旨在区分参与类型,特别是所消费内容的类型与在设备上花费的总时间,并研究它们与结果的关联。第三,我们旨在确定可能影响这些关系的调节因素,如年龄、性别和社会经济地位。本研究的第二个总体目标是建立一个免费的数据资源,合格的研究人员可以访问该资源,以便在未来解决更广泛的问题。

方法

年龄在8至17岁(含)的多达1000名男性、女性和非二元性别的青少年及其主要照顾者将被纳入该研究。青少年参与者必须拥有自己专用的基于iOS或安卓的智能手机或平板电脑,并且他们和他们的父母都必须愿意并能够在其设备上下载并安装数据收集应用程序。该研究对所有符合这两个标准的美国参与者开放。在获得电子同意(eConsent)后,参与者及其照顾者将以电子方式完成一系列基线测量,包括精神和社会功能评估,以及孤独感、数字压力和饮食失调测量。将要求照顾者提供有关参与者健康和心理健康史的信息。青少年和照顾者将在基线后1个月、2个月和3个月完成类似的一系列评估。青少年参与者还将回答有关他们的情绪、压力、身体活动和睡眠的每日问题。青少年及其照顾者在每个时间点完成测量都将获得报酬。数据收集应用程序从参与者的设备收集广泛的每日数据,包括使用的时间模式、各种应用程序使用的数量和频率、应用程序内的社交互动以及按键数据。将使用多种分析方法来解决与技术和社交媒体使用如何与心理健康和幸福感结果相关的关键问题。

结果

本研究于2024年11月13日开始招募。截至2025年5月20日,共有106名参与者及其照顾者同意参与并提供了基线数据。另有203名儿童及其父母已同意,目前正在进行资格验证和招募。预计初步数据分析将于2025年秋末或2026年冬季开始,初步结果预计于2026年春季发表。

结论

本研究将是迄今为止收集客观设备使用数据和经过验证的、与临床相关的结果测量的最大规模研究之一。根据我们的数据共享政策,任何合格的研究人员都能够访问研究数据,前提是遵循适当的步骤。

试验注册

ClinicalTrials.gov NCT06664944;https://clinicaltrials.gov/ct2/show/NCT06664944。

国际注册报告标识符(IRRID):DERR1-10.2196/69358。

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