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Completed

NCT Number: NCT06664944

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

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.

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Key information

Conditions

Mood Anxiety Disorders Behavior Depression Disorders Eating Disorders Feeding and Eating Disorders Loneliness Mental Disorders Motor Activity Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Signs and Symptoms, Digestive Sleep Stress

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aura

Boston, Massachusetts, 02210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Examine bivariate associations between technology use features and mental wellness and mental health outcomes

    Time frame: December 2025

    Given the wide range of variables that can be derived from the Aura app, and the number of assessments that will be collected, all analyses should be considered exploratory. As an initial exploration of this objective, we will conduct simple bivariate analyses between technology use variables and mental health outcomes. Example questions include:

    • Are the temporal patterns of device usage (eg., more evening or late-night use) associated with sleep or physical activity outcome measures?
    • Does digital stress mediate the relationship between device usage and mental health outcomes?

  2. Develop preliminary predictive models that use technology use and smartphone-derived parameters to predict point-in-time mental health outcomes

    Time frame: December 2025

    Develop preliminary predictive models that use technology use and smartphone-derived parameters to predict point-in-time mental health outcomes, as well as change over time.

    A wide range of analytic techniques will be used to develop and evaluate predictive models to determine whether mental health related outcomes and their change over time can be reliably predicted from device usage data. Example prediction models that may be evaluated but are not limited to the following:

    Do patterns/changes in device-mediated social interactions predict presence/severity of loneliness? Are there specific patterns of keyboard data (specific search terms, text messaging sentiment, etc.) that predict changes in mood or anxiety outcomes? Related, do patterns of keyboard activity map onto daily ratings of mood/stress/anxiety? Can patterns of device usage predict changes in health care utilization over time?

Sponsors and collaborators

Lead sponsor

Aura

Industry

Registry information

Official study title

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

Acronym: TECHWISE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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