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

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.

Duke Scholars

Author Scott Haden Kollins Psychiatry, Child & Family Mental Health & Community Psychia ...