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

Aura

Status: Enrolling

Conditions: Physical Activity; Eating Disorders; Depression Disorders; Loneliness; Mood; Anxiety Disorders; Sleep; Stress

Study type: Observational

Funder types: Industry

Identifiers

NCT06664944

20243405

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Child participants are male, female, non-binary persons, ages 8-17, inclusive
2. Parent/Authorized Legal Guardian willing to provide informed consent; child willing to provide assent
3. 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.
4. 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).
5. 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.
6. Both Parent/Authorized Legal Guardian and child willing to share data collected as part of the Aura app and related device applications
7. Consented Parent/Authorized Legal Guardian and child maintain active Aura accounts throughout their study participation
8. 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
9. Consented Parent/Authorized Legal Guardian and child are to comply with all testing and study requirements

Trial design

1,000 participants in 1 patient group

Children 8-17 years old

Description:

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.